Stage: clinical T1 >= 1.0 cm, T2 or T3, N0-3, M0; participants with multicentric or bilateral disease are eligible if at least one lesion meets stage eligibility criteria for the study (i.e., >= 1.0 cm operable breast cancer) and no tumor is human epidermal growth factor receptor 2 (HER2)-positive (3+ by immunohistochemistry [IHC] or in situ hybridization [ISH] amplified >= 2.0); in this circumstance, the investigator must determine which will represent the target lesion to be assessed for response; this should remain consistent throughout the study; the target lesion should be selected on the basis of its size (lesion with the longest diameter) and suitability for accurate repetitive measurementsXx_NEWLINE_xXHER 2 status: tumors must be HER2 negative defined as HER2 0 or 1+ by immunohistochemical (IHC) assays and/or lack of gene amplification by fluorescence in situ hybridization (FISH) defined as a ratio < 2 on invasive tumor; a tumor is considered HER2+ if 3+ by IHC or ISH amplified >= 2.0Xx_NEWLINE_xXEstrogen receptor (ER) and progesterone receptor (PgR) status by immunohistochemistry must be known; ER positive tumors are allowed in patients for whom the treating investigator has determined neoadjuvant chemotherapy is appropriateXx_NEWLINE_xXER(+) and/or PR(+) by IHC (? 10% staining or Allred score ? 4)Xx_NEWLINE_xXHER2 0, 1+, or 2+ by IHC if HER2 testing is performedXx_NEWLINE_xXHer-2 negative, defined as:\r\n* In-situ hybridization (ISH) ratio of < 2.0 (if performed)\r\n* Immunohistochemistry (IHC) staining of 0-2 positive (+) (if performed) \r\n* Deemed to not be a candidate for Her-2 directed therapyXx_NEWLINE_xXEligible tumor-node-metastasis (TNM) stages include:\r\n* Estrogen receptor (ER) and progesterone receptor (PR) negative (defined as < 1% staining for ER and PR by IHC): T2 or T3 N0, T0-3N1-3\r\n** Note: Patients with T1, N1mi disease are NOT eligible\r\n* ER and/or PR positive (defined as >= 1% staining for ER and/or PR on IHC): T0-3N1-3 or T3N0\r\n** Note: Patients with T0N0, T1N0 and T1, N1mi disease are NOT eligible\r\n* ER and/or PR positive (defined as >= 1% staining for ER and/or PR on IHC): T0-3N1-3 or T3N0\r\n** Note: Patients with T0N0, T1N0, T2N0 and T1-2, N1mi disease are NOT eligible\r\n* The eligibility of neo-adjuvant subjects can be assessed on the basis of clinical (c)TNM or pathologic (yp)TNM; the same eligible TNM combinations apply; patients may be eligible if they meet eligibility requirements at either time point, as long as they do not have T4 disease prior to therapyXx_NEWLINE_xXPatients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2, for whom standard adjuvant endocrine therapy is planned; estrogen and progesterone receptor positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologist (CAP) guidelines as either estrogen receptor (ER) or progesterone receptor (PR) >= 1% positive nuclear staining; HER-2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using immunohistochemistry (IHC), in situ hybridization (ISH) or both; HER-2 is negative if a single test (or all tests) performed in a tumor specimen show: a) IHC negative (0 or 1+) or b) ISH negative using single probe or dual probe (average HER-2 copy number < 4.0 signals per cell by single probe or HER-2/chromosome enumeration probe [CEP] ratio < 2.0 with an average copy number < 4.0 signals per cell by dual probe); if HER-2 IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+; HER-2 equivocal is not eligibleXx_NEWLINE_xXHistologic documentation of women or men with node positive, HER2 negative, anatomic stage II or III breast carcinoma and high risk node negative (defined as estrogen receptor [ER] and progesterone receptor [PR] negative and tumor size > 2 cm) within one year of diagnosis and free of recurrence; patients with pN1mic are eligible; if neoadjuvant therapy was received, either initial clinical stage (determined by physical and or radiologic examination) or post-operative pathologic stage can be used for eligibility purposes, with the higher stage determining eligibility; histologic documentation of node positivity is required; bilateral breast cancers are allowed, as long as both cancers are HER2 negative and at least one of the cancers meets eligibilityXx_NEWLINE_xXAny ER/progesterone receptor (PgR) status allowedXx_NEWLINE_xXThe tumor must have been determined to be human epidermal growth factor receptor 2 (HER2)-negative as follows:\r\n* Immunohistochemistry (IHC) 0-1+; or\r\n* IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to centromere enumerator probe 17 (CEP17) < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells; or\r\n* ISH non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cellsXx_NEWLINE_xXThe tumor must have estrogen receptor (ER)-and progesterone receptor (PgR)-status assessed using current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; patients are eligible if the tumor staining meets one of the following criteria:\r\n* ER-negative and PgR- negative by ASCO/CAP guidelines, OR\r\n* ER or PgR stains are positive in 1-9% of cells and neither is positive in >= 10% of cellsXx_NEWLINE_xXPatients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry [IHC] and/or in situ hybridization [ISH]) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy\r\n* Note: If HER2 status has not been clearly determined (i.e. equivocal/indeterminate), then patients should not be enrolledXx_NEWLINE_xXFemale and male patients must have histologically confirmed invasive breast cancer that meets the following criteria:\r\n* Clinical stage II-III (American Joint Committee on Cancer [AJCC] 7th edition) at diagnosis, based on initial evaluation by clinical examination and/or breast imaging; no metastatic disease allowed\r\n* ER- and PR- should meet one of the following criteria:\r\n** =< 10% cells stain positive, with weak intensity score (equivalent to Allred score =< 3)\r\n** =< 1% cells stain positive, with weak or intermediate intensity score (equivalent to Allred score =< 3)\r\n* HER2 negative (not eligible for anti-HER2 therapy) will be defined as:\r\n** Immunohistochemistry (IHC) 0, 1+ without in situ hybridization (ISH) HER2/neu chromosome 17 ratio OR\r\n** IHC 2+ and ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells OR\r\n** ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells without IHC\r\n** NOTE: patients that originally present with synchronous bilateral tumors are eligible provided both tumors are TNBC, and at least one of them fulfills the remainder eligibility criteria of the protocol; multifocal or multicentric breast cancers are eligible as long as all tumors fulfill eligibility criteria\r\n** NOTE: patients that have a discrepancy in ER/PR/HER2 status between original diagnosis and surgical specimen (only applicable if ER/PR/HER2 status were repeated; repeating it is not mandatory) are not eligible for study participation (i.e. ER/PR/HER2 has to fulfill above criteria in both scenarios)Xx_NEWLINE_xXPatients must have metastatic and/or recurrent (distant or locoregionally recurrent) breast cancer and be HER2 non-over expressing per 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) HER testing guidelines (0 or 1+ by immunohistochemistry [IHC]; and/or HER2 ratio < 2.0 and HER2 copy number < 4 signals/cell by in-situ hybridization [ISH])\r\n* Local Regional Recurrence\r\n** In the breast (after preserving therapy)\r\n** In the chest wall (after mastectomy)\r\n** In the ipsilateral/parasternal/infra-or supraclavicular lymph nodes\r\n** In the skin of the chest wall (not breast)\r\n** In the reconstructed breastXx_NEWLINE_xXPatients must also meet at least one of the following criteria:\r\n* Triple negative: histologically confirmed primary and/or metastatic site that is estrogen receptor (ER)-negative (=< 1%), progesterone receptor (PR)-negative (=< 1%), and HER2–negative\r\n* BRCA mutation: previously confirmed deleterious breast cancer 1, early onset (BRCA1) or breast cancer 2, early onset (BRCA2) germline mutation or suspected deleterious BRCA1 or BRCA2 germline mutation if the classification being used is the 5-tier classification; documentation of germline test results are requiredXx_NEWLINE_xXInvasive breast cancer is estrogen receptor (ER) positive with an Allred score of 6, 7 or 8 by local institution standard protocol; if an Allred score is not reported on the diagnostic pathology report, ER positivity in > 66% cells is eligible; if ER positivity is =< 66%, the staining intensity (weak, intermediate, strong) is needed to calculate the Allred score to determine eligibilityXx_NEWLINE_xXInvasive breast cancer is human epidermal growth factor receptor 2 (HER2) negative; a patient is considered to have HER2 negative breast cancer if one of the following if one of the following applies: \r\n* 0 or 1+ by immunohistochemistry (IHC) and in situ hybridization (ISH) not done\r\n* 0 or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) < 2\r\n* 2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) < 2Xx_NEWLINE_xXTumor ER Allred score between 0-5 or HER2 positive by IHC (3+) or amplified by FISH > 2.0Xx_NEWLINE_xXEstrogen receptor (ER) and/or progesterone receptor (PR) positive histologically confirmed adenocarcinoma of the breast with staining of >= 1% cells will be considered positive; receptor status may be based on any time during treatment prior to study randomization, and from any site (i.e. primary, recurrent, or metastatic)Xx_NEWLINE_xXPatients whose tumors have HER2 immunohistochemistry (IHC) 3+, in situ hybridization (ISH) >= 2.0, or average HER2 copy number >= 6.0 signals per cell are not eligible; receptor status may be based on any time during treatment prior to study randomization, and from any site (i.e. primary, recurrent, or metastatic)Xx_NEWLINE_xXPatients must have had estrogen receptor (ER) analysis performed on the primary breast tumor before neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP guideline recommendations for hormone receptor testingXx_NEWLINE_xXPatients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer; patients who have a primary tumor that is either HER2-positive or HER2-negative are eligibleXx_NEWLINE_xXPatients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicatedXx_NEWLINE_xX* For patients who underwent initial surgery and received adjuvant chemotherapy\r\n** Triple negative breast cancer (TNBC) patients must have been axillary node-positive (>= pN1, any tumor size) or axillary node negative (pN0) with invasive primary tumor pathological size > 2 cm (>= pT2)\r\n** Estrogen receptor (ER) and/or progesterone receptor (PgR) positive/human epidermal growth factor receptor (HER) 2 negative patients must have had >= 4 pathologically confirmed positive lymph nodes\r\n* For patients who underwent neoadjuvant chemotherapy followed by surgery\r\n** TNBC patients must have residual invasive breast cancer in the breast and/or resected lymph nodes (non-pathological complete response [pCR])\r\n** ER and/or PgR positive/HER2 negative patients must have residual invasive cancer in the breast and/or the resected lymph nodes (non-pCR) AND a clinical pathologic stage (CPS) & estrogen receptor status nuclear grade (EG) score >= 3Xx_NEWLINE_xXHistologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the two following phenotypes:\r\n* TNBC defined as:\r\n** ER and PgR negative defined as immunohistochemistry (IHC) nuclear staining < 1%\r\n** HER2 negative (not eligible for anti-HER2 therapy) defined as:\r\n*** IHC 0, 1+ without in situ hybridization (ISH) OR \r\n*** IHC 2+ and ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells OR \r\n*** ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells (without IHC)\r\n* ER and/or PgR positive, HER2 negative breast cancer defined as:\r\n** ER and/or PgR positive defined as IHC nuclear staining >= 1%; AND\r\n** HER2 negative (not eligible for anti-HER2 therapy) defined as:\r\n*** IHC 0, 1+ without ISH OR\r\n*** IHC 2+ and ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells OR\r\n*** ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells (without IHC)Xx_NEWLINE_xXPatients with multifocal or multicentric invasive disease are eligible as long as all the lesions for which HER2 characterization is available are HER2 negativeXx_NEWLINE_xXPatients must have histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)- and HER2-negative (triple-negative, TNBC) or ER, PR, and HER2 equivocal status and must not have received and not be planning to receive adjuvant anti-HER2 or endocrine therapies after completion of neoadjuvant chemotherapy; patients who are HER2 positive by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines are ineligible; HER2 negative and HER2 equivocal cases as per ASCO CAP guidelines that do not receive HER2-targeted therapy are eligible; patients with weekly ER or PR positive disease, defined as ER and/or PR < 5% by immunohistochemistry, are eligible if the treating physician considers the patient not eligible for adjuvant endocrine therapy; residual disease must be >= 1 cm in greatest dimension, and/or have positive lymph nodes (ypN+) observed on pathologic exam\r\n* NOTE: Immunohistochemistry (IHC)-positive isolated tumor cells in the lymph node (N0 [i+]) are not considered node-positive and these patients also must have >= 1 cm residual invasive cancer in the breast in order to be eligibleXx_NEWLINE_xXKnown estrogen, progesterone, and HER2 status of either primary tumor or metastasis; \r\n* Note: estrogen, progesterone and HER2 status of metastasis preferred for stratificationXx_NEWLINE_xXHER2-overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by fluorescent in situ hybridization [FISH] or silver in situ hybridization [SISH] >= 2.0)Xx_NEWLINE_xXPatients must have histologically confirmed ER+ and/or PR+, HER2-, early invasive breast cancer.Xx_NEWLINE_xXPatients must have histologically documented unresectable stage III or IV triple negative breast cancer (TNBC) and a known BRCA 1/2 mutation present; TNBC patients must be Her-2 negative, estrogen receptor (ER) negative (defined as less than 3% ER by immunohistochemistry [IHC]) and progesterone receptor (PR) negative breast cancer (defined as less than 3% PR staining by IHC)Xx_NEWLINE_xXNewly diagnosed triple negative breast cancer (TNBC) clinical stage Ic, II, or III\r\n* Estrogen receptor (ER) and progesterone receptor (PR) < 10%\r\n* HER2 negative based on one of the following:\r\n** Immunohistochemistry (IHC) 0 or 1+\r\n** IHC 2+ and fluorescence in situ hybridization (FISH) negative\r\n** IHC 2+ and FISH equivocal and no indication for HER2 targeted therapy based on the treating investigators discretion (i.e., HER2: CEP17 ratio < 2.0 or HER2 total copy number < 6)Xx_NEWLINE_xXEstrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) testing performed on the primary breast tumor; when applicable, testing must have been performed prior to neoadjuvant chemotherapyXx_NEWLINE_xXThe study is open to all males and females who meet the following inclusion criteria at\n        screening and baseline to participate in the study.\n\n        To be included to participate in this study each patient must:\n\n          -  be ? 18 years of age;\n\n          -  have an Eastern Cooperative Oncology Group performance status of 0-1 (not declining\n             within past 2 weeks, see Appendix 1);\n\n          -  have confirmed HER2 gene amplified tumor fluorescence in-situ hybridization (FISH,\n             HER2/cep17 ratio > 2) or HER2 overexpression (IHC 3+) or documented HER2 gene\n             mutation. Documentation of HER2 status using FDA approved test(s) for HER2 testing\n             specific for HER2 breast and gastric cancer is required prior to screening;\n\n          -  for part 1:\n\n               1. Patients with HER2 positive (defined as documented overexpression or\n                  amplification or mutation) metastatic breast cancer who have experienced disease\n                  progression following at least 2 prior anti-HER2 therapies for metastatic disease\n                  that contain trastuzumab with or without pertuzumab, prior T-DM1, or lapatinib\n                  therapy is required;\n\n               2. Patients with HER2 positive metastatic gastric cancer who have disease\n                  progression on prior trastuzumab therapy;\n\n               3. other HER2-positive solid tumors (defined as documented overexpression or\n                  amplification or mutation) that have no approved targeted agent as standard of\n                  care\n\n          -  for part 2:\n\n               1. Patients with HER2 positive metastatic breast cancer who have experienced disease\n                  progression after at least 2 prior anti-HER2 therapies for metastatic disease\n                  that contain trastuzumab with or without pertuzumab, prior T-DM1, or lapatinib\n                  therapy is required;\n\n               2. Patients with documented HER2 mutated NSCLC whose disease progressed on prior\n                  therapy;\n\n               3. Patients in Part 2 extension must have at least one measurable lesion as defined\n                  by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria;\n\n          -  Left ventricular ejection fraction within institutional limits of normal (by multi\n             gated acquisition scan or echocardiography;\n\n          -  have the required screening laboratory values including the following parameters:\n\n               1. Absolute neutrophil count ? 1.5×109/L (1,500/mm3);\n\n               2. Platelets ? 75×109/L (75,000/mm3);\n\n               3. Hemoglobin ? 9.0 g/dL (90 g/L);\n\n               4. Total bilirubin ? 1.5× upper limit of normal (ULN);\n\n               5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ? 2.5×ULN;\n                  for patients with liver metastases, ALT and AST ? 5×ULN;\n\n               6. Serum creatinine ? 1.5×ULN;\n\n          -  have a life expectancy of > 12 weeks;\n\n          -  for female patients who are of child bearing potential, a negative serum pregnancy\n             test result before study entry. A female patient of childbearing potential is one who\n             is biologically capable of becoming pregnant. This includes women who are using\n             contraceptives or other means of birth control or whose sexual partners are either\n             sterile or using contraceptives;\n\n          -  and who have provided informed consent by signing the informed consent form.\n\n        Main Exclusion Criteria:\n\n        Patients who meet any of the criteria listed below will not be eligible for participation\n        in this study. A patient will not be eligible for study participation if:\n\n          -  is unable or unwilling to swallow pyrotinib;\n\n          -  has been < 2 weeks since the last radiotherapy, chemotherapy, hormone therapy, surgery\n             or molecule-target therapy (< 6 weeks if chemotherapy included nitrosoureas or\n             mitomycin);\n\n          -  the bone or skin is the only site of disease (for Part 2 extension only);\n\n          -  has pleural or peritoneal only disease;\n\n          -  has uncontrolled ? grade 2 hypokalemia and hypomagnesemia;\n\n          -  has had other cancer(s) within 5 years prior to screening with the exception of\n             contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or\n             adequately treated basal or squamous cell carcinoma of the skin;\n\n          -  has active central nervous system (CNS) metastases, as indicated by clinical symptoms,\n             cerebral edema, and/or progressive growth (patients with a history of CNS metastases\n             or cord compression are allowable if they have been definitively treated and have been\n             clinically stable for at least 4 weeks, and off steroids and anticonvulsants, before\n             first dose of study drug);\n\n          -  has either QTcF prolongation (> 470 ms for female and > 450 ms for male), a known\n             history of QTcF prolongation or Torsade de Pointes; or is on drugs that are required\n             for existing medical conditions and that may result in QT prolongation (e.g.,\n             anti-arrhythmic drugs); patients who use medications that have a minimal impact on the\n             QTcF interval in the Arizona-CERT criteria are allowed to participate in this study at\n             Investigator's discretion based on his/her clinical assessment);\n\n          -  has a significant chronic or recent acute gastrointestinal disorder with diarrhea as a\n             major symptom (e.g., Crohn's disease, malabsorption, or ? grade 2 diarrhea of any\n             etiology at baseline);\n\n          -  has participated in any other investigational drug clinical studies within the last 4\n             weeks;\n\n          -  is concurrently receiving other anti-tumor therapies at time of study screening visit;\n\n          -  has an active infection (per Investigator judgment);\n\n          -  has a history of immunodeficiency including seropositive for human immunodeficiency\n             virus, or has other acquired or congenital immunodeficient disease;\n\n          -  has evidence of uncontrolled heart disease, including (1) congestive heart failure\n             (New York Heart Association functional classification) of ? 2), (2) angina requiring\n             treatment (3) myocardial infarction within the past 12 months, or (4) any clinically\n             significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment\n             or intervention;\n\n          -  has allergies or a known history of hypersensitivity to any components of the\n             pyrotinib;\n\n          -  is female and of childbearing potential (WOCBP) who is unwilling or unable to use an\n             acceptable method (barrier methods only) to avoid pregnancy for the entire study\n             period and for up to 28 days post last dose;\n\n          -  is female and pregnant (or found to be pregnant at screening) or breastfeeding;\n\n          -  evidence of significant medical illness or an abnormal laboratory finding, which\n             according to the Investigator's judgment, will substantially increase the risk of\n             participation in and completion of the study. Including, but not limited to, serious\n             ongoing infection (ie, requiring intravenous antibiotic or antiviral agent),\n             uncontrolled major seizure disorder, or significant pulmonary disorder (e.g.\n             interstitial pneumonitis, pulmonary hypertension); hypertension (> grade 3), severe\n             diabetes (uncontrolled > grade 3 hyperglycemia), serious ongoing infection or thyroid\n             disease;\n\n          -  has a known history of neurological psychiatric disease including epilepsy or dementia\n             that would interfere with patient's ability to participate in the study or to provide\n             consent;\n\n          -  has had prior exposure to any other investigational HER2 targeted agents within 4\n             weeks of screening visit.\n\n          -  is currently taking strong CYP3A4 inhibitor or concomitant meds.Xx_NEWLINE_xXMetastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expressionXx_NEWLINE_xXParticipants must have histologically confirmed HER2+ invasive breast cancer (immunohistochemistry [IHC] 3+ and/or fluorescence in situ hybridization [FISH] positive [HER2/chromosome 17 centromere [CEP17] >= 2 and/or > 6 HER2 gene copies per nucleus]); note: central confirmation of HER2 status is not requiredXx_NEWLINE_xXFor Cohort E only: Patients must have histologically confirmed HER2+ (IHC 3+ and/or FISH positive [HER2/CEP17 >= 2 and/or > 6 HER2 gene copies per nucleus]) and hormone receptor positive (estrogen receptor [ER]+ and/or progesterone receptor [PR]+ >= 1%), metastatic breast cancerXx_NEWLINE_xXHER2+ and HER2- patients are eligibleXx_NEWLINE_xXPrimary tumors and/or metastatic lesions must demonstrate HER2-neu overexpression by immunohistochemistry (IHC 3+) or amplification by in situ hybridization based on the following:\r\n* Single-probe average HER2 copy number >= 6.0 signals/cell\r\n* Dual-probe HER2/chromosome enumeration probe 17 (CEP17) ratio >= 2.0 with an average HER2 copy number >= 4.0 signals/cell\r\n* Dual-probe HER2/CEP17 ratio >= 2.0 with an average HER2 copy number < 4.0 signals/cell\r\n* Dual-probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number > 6.0 signals/cell\r\nPatients may be estrogen and/or progesterone positive (>= 1%) or negative (< 1%); hormone receptor status will be a stratification factorXx_NEWLINE_xXFor Phase 2a, subjects with one of the following tumor types will be enrolled: i. Urothelial cancer with HER2 or HER3 mutation ii. Biliary tract cancer with HER2 or HER3 mutation iii. Breast cancer with HER2 or HER3 mutation iv. Breast cancer with HER2 amplification or overexpression v. NSCLC with HER2 or HER3 mutation vi. CRC with HER2 mutation or amplification vii. Other tumors with HER2 mutation/amplification/overexpression or HER3 mutation (gastric/GEJ, endometrial).Xx_NEWLINE_xXKnown positivity for HER2 (as defined by a positive IHC test of 3+ or IHC of 2_ with fluorescent in situ hybridization [FISH])Xx_NEWLINE_xXAssessment of HER2 status in patients with breast cancer should follow the 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria (37) as practicable.Xx_NEWLINE_xXEstrogen receptor positive (ER+) breast cancer patients must have received and progressed on fulvestrant and be post-menopausalXx_NEWLINE_xXMetastatic breast cancer with any evidence of estrogen receptor (ER) or progesterone receptor (PR) positivity in >= 1% cells in biopsy specimens from either a primary or metastatic site is eligibleXx_NEWLINE_xXEvidence of HER2 positive metastatic breast cancer in either a primary or metastatic site, if 3+ by an immunohistochemistry (IHC) method defined as uniform membrane staining for HER2 in 10% or more of tumor cells or demonstrate HER2 gene amplification by an in situ hybridization (ISH) method (single probe, average HER2 copy number >= 6.0 signals/cell; dual probe HER2/chromosome enumeration probe [CEP] 17 ratio >= 2.0 with an average HER2 copy number >= 4.0 signals/cell; dual probe HER2/CEP 17 ratio >= 2.0 with an average HER2 copy number < 4.0 signals/cell; and HER2/CEP17 ratio < 2.0 with an average HER2 copy number >= 6.0 signals/cell) or amplified by fluorescence in situ hybridization (FISH) > 2.0; high average copy number of HER2 (>= 6.0 signals/cell) is considered positive regardless of the HER2/CEP17 ratioXx_NEWLINE_xXHER2 negative metastatic breast carcinoma defined as 0 or 1+ by IHC or with a FISH ratio (HER2 gene copy/ chromosome 17) < 2 if IHC 2+ by local institution standard protocolXx_NEWLINE_xXCohort B Safety Run-In (Ribociclib + PDR001 + Fulvestrant): Hormone receptor (HR)-positive, HER2-negative metastatic breast cancer according to ASCO CAP guidelinesXx_NEWLINE_xXExpansion Cohort B (Ribociclib + PDR001 + Fulvestrant): Hormone receptor (HR)-positive, HER2-negative metastatic breast cancer according to ASCO CAP guidelinesXx_NEWLINE_xXHistological confirmation of HER2-positive advanced breast cancer; HER2+ is defined by 2013 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelinesXx_NEWLINE_xXParticipants with locally advanced or metastatic, histologically documented TNBC (absence of human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PR] expression), not amenable to surgical therapyXx_NEWLINE_xXThe following disease subtypes are eligible:\r\n* Triple negative disease (defined as estrogen receptor [ER] < 10%, progesterone receptor [PR] < 10%, HER2 negative)\r\n* Hormone receptor positive, HER2 negative disease with evidence of progression on at least two prior lines of hormone therapy\r\n* HER2 positive disease with evidence of disease progression on trastuzumab, pertuzumab, T-DM1 and oral tyrosine kinase inhibitor unless contraindicated with no other HER2 targeted therapy options available (patients in this category will be classified by ER status)\r\n** Histologically confirmed HER2+ breast carcinoma, with HER2+ defined by in situ hybridization (ISH) or fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) methodology using standard criteria.\r\n** Cardiac function must be determined within 4 weeks of study entry to be >= institutional lower limit of normal (LLN) using echo or multigated acquisition scan (MUGA)Xx_NEWLINE_xXHER2 positive patients by local laboratory testing.Xx_NEWLINE_xXtrastuzumab in case of HER2-positiveXx_NEWLINE_xXEither the primary tumor and/or the metastasis must have been tested for estrogen receptor (ER), progesterone receptor (PR) and HER2; patient must have HER2+ breast cancer per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines 2013Xx_NEWLINE_xXHistologically or cytologically confirmed locally advanced or metastatic gastric cancer and HER2 IHC 3+ or positive for HER2 gene amplification ORXx_NEWLINE_xXParticipants with histologically or cytologically confirmed hormone receptor (HR)-positive, Her2-negative metastatic breast cancer; central confirmation of HR positivity is not requiredXx_NEWLINE_xXHistologically confirmed HER2-positive metastatic breast cancer (HER-2 3+ by immunohistochemistry); if immunohistochemistry (IHC) score of 2, fluorescence in situ hybridization (FISH) ratio must be greater than 2.0; if FISH less than 2.0, HER2 copy number must be greater than 6; NOTE: Brain lesions are not required to have pathologic confirmation; estrogen receptor (ER)-positive patients are allowedXx_NEWLINE_xXSAFETY RUN-IN: Women diagnosed with pathologically confirmed metastatic triple negative invasive breast cancer (centrally confirmed immunophenotype negative for all three receptors estrogen receptor [ER], progesterone receptor [PR] and human epidermal growth factor receptor 2 [HER2])Xx_NEWLINE_xXSAFETY RUN-IN: Hormone receptor status (ER and PR) both =< 5% by immunohistochemistry, and HER2 status confirmed by means of immunohistochemistry (with 0 or 1+ indicating negative status) or fluorescence in situ hybridization (with amplification ratio < 2.0 indicating negative status)Xx_NEWLINE_xXSAFETY RUN-IN: Patients with hormone-receptor positive breast cancer (ER and/or PR > 5%), and with HER-2 positive breast cancer (by means of immunohistochemistry with 3+ indicating positive status or fluorescence in situ hybridization with amplification ratio >= 2.0 indicating positive status)Xx_NEWLINE_xXRANDOMIZED PHASE II CLINICAL TRIAL: Women diagnosed with pathologically confirmed triple negative invasive breast cancer, metastatic (locally confirmed immunophenotype negative for all three receptors ER, PR, HER2)Xx_NEWLINE_xXRANDOMIZED PHASE II CLINICAL TRIAL: Hormone receptor status (ER and PR) both =< 5% by immunohistochemistry, and HER2 status confirmed by means of immunohistochemistry (with 0 or 1+ indicating negative status) or fluorescence in situ hybridization (with amplification ratio < 2.0 indicating negative status)Xx_NEWLINE_xXRANDOMIZED PHASE II CLINICAL TRIAL: Patients with hormone-receptor positive breast cancer (ER and/or PR > 5%), and with HER-2 positive breast cancer (by means of immunohistochemistry with 3+ indicating positive status or fluorescence in situ hybridization with amplification ratio >= 2.0 indicating positive status)Xx_NEWLINE_xXParticipants must have histologically confirmed invasive breast cancer, with locally advanced or metastatic disease; patients without pathologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation; for subjects in Cohort C, the tumor must also be hormone receptor positive, defined as demonstrating at least 1% tumor cell nuclei staining positive for either ER or progesterone receptor (PR)Xx_NEWLINE_xXThe primary tumor, and/or metastasis must have been tested for ER, PR and HER 2, and be HER2 positive as defined by the 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelinesXx_NEWLINE_xXFor Part B exclusively (RO6874281 in combination with trastuzumab), participants with metastatic or recurrent or locally advanced human epidermal growth factor receptor 2 (HER2)-positive breast cancer, as defined by the College of American Pathologists HER2 testing guidelines, who have progressed on at least two lines of HER2-directed therapies in the metastatic setting and the last therapy prior to going on study has to contain a HER2-directed antibody; baseline left ventricular ejection fraction (LVEF) of >=50% (measured by echocardiography) predose on Cycle 1 Day 1Xx_NEWLINE_xXParticipants must NOT have HER2 positive status based on American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines defined as:\r\n* Immunohistochemistry (IHC) 3+ based on circumferential membrane staining that is complete, intense -AND/OR – \r\n* Fluorescence in situ hybridization (FISH) positive based on one of the three following criteria:\r\n** Single-probe average HER2 copy number >= 6.0 signals/cell; OR\r\n** Dual-probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number >= 6.0 signals/cell; OR\r\n** Dual-probe HER2/CEP17 ratio >= 2.0Xx_NEWLINE_xXHistologically documented HER2-positive and HER2-negative (cohort E only) breast cancerXx_NEWLINE_xXBreast cancer must be estrogen receptor (ER)-negative, and HER-2 negative according to College of American Pathologists (CAP)/American Society of Clinical Oncology (ASCO) biomarkers testing guidelines; tumors may be progesterone receptor (PgR) positive with an Allred score of less than 5Xx_NEWLINE_xXHistologically confirmed triple negative breast cancer (estrogen receptor [ER] < 10%, progesterone receptor [PR] < 10%, Her2neu immunohistochemistry [IHC] 0 or 1 or fluorescence in situ hybridization [FISH]/in situ hybridization [ISH] negative)Xx_NEWLINE_xXPatients must harbor a tumor HER2/neu+ based upon IHC staining score of “3+” or 2+ with confirmed gene amplification by fluorescence in situ hybridization (FISH) to be includedXx_NEWLINE_xXPrimary and/or metastatic breast tumor must be negative for over-expression of estrogen and progesterone receptors; patients with weak estrogen receptor and/or progesterone receptor expression (< 10% on immunohistochemistry [IHC]) will be eligibleXx_NEWLINE_xXPrimary and/or metastatic breast tumor must be negative for human epidermal growth factor receptor (HER-2/neu) over-expression based on immunohistochemistry (IHC) (0 or 1+, 2+ if fluorescence in-situ hybridization [FISH] test is negative) or FISH (HER2/copy number of centromere of chromosome 17 [CEP17] ratio < 2.0 or < 4 Her-2/neu signals per nucleus)Xx_NEWLINE_xXHistologically or cytologically confirmed invasive breast cancer of the following subtype:\r\n* TRIPLE NEGATIVE (estrogen receptor [ER]-negative, progesterone receptor [PR]-negative, and HER2-negative disease); triple-negative patients will be defined per American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines\r\n* HER2-POSITIVE: HER2-positive patients will be defined per ASCO-CAP guidelines\r\n* HORMONE REFRACTORY: patients with ER/PR-positive disease according to ASCO-CAP guidelines above may be considered if they have disease progression after two lines of hormonal therapy (administered in the adjuvant or metastatic setting), or are deemed clinically hormone-resistant taking into consideration the rate of progression of disease or a short interval of time on first line hormonal therapy before progression; clinically hormone resistant patients MUST also be discussed with the Study Chair, Study co-Chair (Roisin Connolly, MBBCh), or designee in advance for approval\r\n** NOTE: ASCO-CAP guidelines state that ER and PR assays be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls; HER2-positive is defined as HER2 immunohistochemistry (IHC) 3+, in situ hybridization (ISH) >= 2.0, or average HER2 copy number >= 6.0 signals\r\n** NOTE: a patient who has a change in receptor status (e.g. PR negative to positive) may be stratified as triple negative or hormone positive, contrary to the most recent receptor testing, for the purposes of the study, based upon the clinical course at the discretion of the Study Chair, Study co-Chair (Roisin Connolly, MBBCh), or designee in advance for approvalXx_NEWLINE_xXPatients with pathologically documented metastatic triple negative breast cancer (TNBC), eligible for treatment with paclitaxel. Paraffin-embedded tissue must be available from metastatic sites, if reasonably accessible, or from the primary tumor, to confirm the diagnosis of TNBC and for correlative studies (only on metastatic tissue). Fifteen slides can be obtained if the full block is not available to be sent or released. TNBC will be defined as breast cancer with <1% ER+ and <1% PgR+ cells, and HER2 immunohistochemistry score of 0 or 1+ and/or in situ hybridization (ISH) with HER2 gene copy number <4 or a ratio of less than 2 between HER2 gene copy number and centromere of chromosome 17. Patients whose metastatic disease is TNBC are eligible even when their primary tumor expressed hormone receptors and/or HER2.Xx_NEWLINE_xXRecovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v.4.0) from toxicities related to any prior treatments, unless adverse event(s) (AE[s]) are clinically nonsignificant and/or stable on supportive therapy:\r\n* Cohort 1: HER2-positive, defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) 2013 guidelines: \r\n** IHC 3+ based on circumferential membrane staining that is complete, intense OR\r\n** FISH positive based on one of the three following criteria:\r\n*** Single-probe average HER2 copy number >= 6.0 signals/cell; OR\r\n*** Dual-probe HER2/chromosome 17 centromere (CEP17) ratio < 2.0 with an average HER2 copy number >= 6.0 signals/cell; OR\r\n*** Dual-probe HER2/CEP17 ratio >= 2.0\r\n* Cohort 2: Hormone receptor positive (estrogen receptor [ER]-positive and/or progesterone receptor [PR]-positive, defined as >= 1% staining by immunohistochemistry) and HER2-negative\r\n* Cohort 3: Triple negative (ER-negative, PR-negative, HER2-negative)Xx_NEWLINE_xXHormone receptor (HR) status of the invasive component must be documented before trial enrollment; the tumor must be HR-positive; HR will be considered positive if staining is 1% or greater for ER and/or PR; this will be determined at the enrolling institution for purposes of study participation and enrollment onto the trial; subsequently, HR status will be confirmed by central pathology review, but this central review will not be required prior to enrolling the patient; HER2 status will be determined locally only, based upon current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelinesXx_NEWLINE_xXEstrogen receptor positive, progesterone receptor positive, HER2 negativeXx_NEWLINE_xXHER2 negative in the primary tumor as defined by:\r\n* Grade 0 or 1+ staining intensity (on a scale of 0 to 3) by means of immunohistochemistry (IHC) analysis OR\r\n* Grade 2+ staining intensity by means of IHC analysis with gene amplification on fluorescence in situ hybridization (FISH) < 2.0 OR\r\n* Gene amplification on fluorescence in situ hybridization (FISH) < 2.0Xx_NEWLINE_xXHave a diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer for Parts A to E, G, and I.Xx_NEWLINE_xXTumor positive or negative for expression of hormone receptors (< 1% or > 1%) and overexpressing HER2 by immunohistochemistry (IHC) (3+), or, HER2-amplified by fluorescence in situ hybridization (FISH) or by alternative gene testingXx_NEWLINE_xXENDOCRINE RESISTANT COHORT: Clinical T2-T4c at diagnosis or screening, any N, M0 invasive ER+ (Allred score at least 3 or > 1% ER positivity) and HER2 negative (0 or 1+ by IHC or FISH negative or equivocal) breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node\r\n* Note: patients with invasive breast cancer that is ER positive (pos), HER2 negative (neg) or equivocal or DCIS in the contralateral breast are eligible; multi-focal diseases are not excluded; the dominant lesion will be followed per protocolXx_NEWLINE_xXHave a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer • Prior combined CDK 4/6 inhibitor and endocrine therapy and 1 or 2 prior lines of chemotherapyXx_NEWLINE_xXBreast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (triple-negative breast cancer; TNBC);Xx_NEWLINE_xXEither the primary tumor and/or metastatic tumor must be triple-negative as defined below:\r\n* Hormone receptor status: the invasive tumor must be estrogen receptor (ER)- and progesterone receptor (PR)-negative, or staining present in < 1% by immunohistochemistry (IHC)\r\n* HER2 status: the invasive tumor must be human epidermal growth factor receptor 2 negative (HER2-negative) by the American Society of Clinical Oncology College of American Pathologists (ASCO CAP) guidelines\r\n* Note: In cases where both primary tumor and metastatic sample(s) have been tested for ER, PR, and HER2, the triple-negative status of the most recent sample should be usedXx_NEWLINE_xXPathologically confirmed HER2-positive MBC by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in situ hybridization with a ratio of HER2-gene signals to centromere 17 signals ? 2.0 or average HER2 copy number ? 6.0 signals/cells)Xx_NEWLINE_xXHistopathological diagnosis of metastatic or inoperable locally advanced triple negative breast cancer (TNBC) that meets the following criteria:\r\n* Triple negative is generally defined as estrogen receptor (ER) < 1%, progesterone receptor (PR) < 1%, and HER2 negative according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines by local testing according to institutional standards\r\n** Note: for tumors with equivocal interpretation of receptor status (e.g., ER/PR >= 1% “weak” or “faint” staining), the principal investigator will have final determination of triple-negative status; for tumors with discrepant receptor results between 2 or more biopsies (including metastatic and/or early stage biopsies), the principal investigator will have final determination of triple negative status, but in general the most recent biopsy can be used for eligibility purposes; if receptor testing is not available on a metastatic biopsy, the primary tumor test result is acceptable\r\n* Metastatic or inoperable locally advanced disease is defined as either: histologically confirmed metastatic breast cancer by biopsy; or locally advanced breast cancer that, in the opinion of the treating physician, is not amenable to curative intent surgical resection; or, radiological or clinical evidence suggestive and supportive of metastatic disease without a documented metastatic biopsy, provided the patient has a prior diagnosis of TNBC that otherwise meets the eligibility criteria\r\n* Ductal, lobular, mixed, or metaplastic histologyXx_NEWLINE_xX<1% staining by immunohistochemistry (IHC) for estrogen (ER) and progesterone (PR) receptors, 0 or 1+ IHC for human epidermal growth factor receptor 2 (HER2), ORXx_NEWLINE_xXNegative for HER2 amplification by in situ hybridization (ISH) for 2+ IHC disease.Xx_NEWLINE_xXLocal testing on the diagnostic core must have determined the tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines. (If local testing has determined a tumor to be HER2 equivocal or to have a borderline ER/PgR status (% IHC staining < 10% for both) and other eligibility criteria are met, material may be submitted for central testing to determine eligibility.)Xx_NEWLINE_xXCentral testing for ER, PgR, and HER2 will be performed, and the tumor must be determined to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP Guidelines Recommendations. Material from either the diagnostic core biopsy or the research biopsy can be used for central testing depending on local preferences and standards.Xx_NEWLINE_xXPatients with synchronous bilateral or multicentric HER2-negative breast cancer are eligible as long as the highest risk tumor is ER-negative and PgR-negative and meets stage eligibility criteria. All of the other invasive tumors must also be HER2-negative by ASCO/CAP Guidelines based on local testing. Central testing to confirm TNBC status is only required for the highest risk tumor.Xx_NEWLINE_xXFemale or male subjects whose advanced HER2 expressing cancer has failed standard of care treatments, or for whom such therapy is not acceptable to the subject. Subjects with advanced breast and gastric cancer who test positive for HER2 by ASCO/CAP criteria (either IHC or FISH) must have received prior treatment with a trastuzumab containing therapy. Subjects who have been previously treated with pertuzumab, TDM-1, lapatinib, or other available and accessible HER2-directed therapies or investigational therapies are eligible.Xx_NEWLINE_xXTumor tissue local laboratory HER2 testing results (clinical pathology report) based on FDA or other regulatory agency approved, validated or commercially available IHC or ISH HER2 assay. Pre-screening for HER2 is allowed only for subjects with breast and gastric cancer, GE junction or esophageal cancer, where applicable. Subjects with other types of cancer must have previously tested for HER2 status by HER2 IHC or ISH assay.Xx_NEWLINE_xXParticipant has human epidermal growth factor receptor 2 (HER2) negative breast cancer as defined by American Society of Clinical Oncology (ASCO)-College of American Pathologists guidelines.Xx_NEWLINE_xXHistologically documented TNBC (negative human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PgR] status)Xx_NEWLINE_xXPart 2, Cohort 5, Postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer who have failed prior treatment with a CDK 4/6 inhibitor in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy.Xx_NEWLINE_xXInvasive disease must have been tested for estrogen receptor (ER), progesterone receptor (PR) and HER2; participants must have hormone-receptor positive, HER2-negative breast cancer defined as:\r\n* ER > 1% or PR > 1%\r\n* HER2-negative per American Society of Clinical Oncology (ASCO) College of American Pathologist (CAP) guidelines, 2013Xx_NEWLINE_xXEither the primary invasive tumor and/or the metastasis must be triple-negative, defined as:\r\n* Hormone-receptor poor, estrogen receptor (ER)- and progesterone receptor (PR)-negative, or staining present in < 1% by immunohistochemistry (IHC)\r\n* HER2-negative: 0 or 1+ by IHC, or fluorescence in situ hybridization (FISH) < 2.0Xx_NEWLINE_xXHistologically confirmed metastatic ER positive (+) and/or PR+ and HER2 negative (-) breast cancer who are candidates for palbociclib in combination with either letrozole or fulvestrant per treating physicianXx_NEWLINE_xXPart A) Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or ER-positive and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting and are no longer a candidate for hormonal therapy (not enrolling new patients);Xx_NEWLINE_xXPart E) ER-positive and/or PR-positive/HER2- disease and received no more than 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting.Xx_NEWLINE_xXHistologically or cytologically confirmed HER2-negative (0 or 1+ by immunohistochemistry [IHC] or non-amplified by fluorescent in situ hybridization [FISH]) breast cancer that is stage IVXx_NEWLINE_xXINCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASHINGTON UNIVERSITY [WASH U] GENOMICS AND PATHOLOGY SERVICES [GPS] LABORATORY): Tumor tissue tested positive for HER2 mutation; mutations outside the list will be assessed on a case-by-case basis by the study team to determine eligibility\r\n* Note: HER2 mutations listed and detected by Guardant360 are also eligibleXx_NEWLINE_xXINCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): To be eligible for the Part II fulvestrant-naive ER+ cohort, prior treatment with fulvestrant is not allowed; in addition, ER and/or progesterone receptor (PR) positivity by institutional standard is required on pathology from the most recent tumor specimen if biopsy was done unless the tissue source (for example, pleural effusion or ascites or bone biopsy) may yield false negative ER and/or PR result, in which case the pathology from an earlier time point could be used and a discussion with the study chair is requiredXx_NEWLINE_xXINCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLINICAL LABORATORY IMPROVEMENT ACT [CLIA] CERTIFIED LOCATION): Histologically or cytologically confirmed HER2-negative (0 or 1+ by IHC or non- amplified by FISH) breast cancer that is stage IVXx_NEWLINE_xXInvasive disease must have been tested for estrogen receptor (ER), progesterone receptor (PR), and HER2 and participants must have hormone receptor-positive, HER2-negative breast cancer (ER > 1% or PR > 1%, AND HER2-negative per American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines, 2013)Xx_NEWLINE_xXAll patients must have one of the following pathologically documented recurrent tumor types with FRalpha positivity by the Ventana immunohistochemistry (IHC):\r\n* Ovarian, primary peritoneal, fallopian tube (with exclusion of low grade, clear cell or sarcomatoid histologies for ovarian cancer) >= 25% of tumor staining >= 2+ intensity\r\n* Endometrial >= 25% of tumor staining >= 2+ intensity\r\n* TNBC confirmed by medical history of HER2-negative (confirmed by IHC 0, 1+ regardless of fluorescence in situ hybridization [FISH] ratio; IHC 2+ with FISH ratio < 2.0 or HER2 gene copy < 6.0; FISH ratio of 0, indicating gene deletion; when positive and negative in situ hybridization controls are present); estrogen receptor (ER) negative (confirmed as ER expression =< 1% positive tumor nuclei); progesterone receptor (PR) negative (confirmed as PR expression =< 1% positive tumor nuclei): >= 25% of tumor staining >= 1+ intensityXx_NEWLINE_xXNewly diagnosed ER-positive, HER2-negative breast cancer. ER-positive is defined as ? 1% immunohistochemical (IHC) staining of any intensity. HER2 test result is negative if a single test (or both tests) performed show:Xx_NEWLINE_xXIn situ hybridization negative based on:Xx_NEWLINE_xXDual-probe HER2/CEP17 ratio < 2 with an average HER2 copy number < 4.0 signals/cell.Xx_NEWLINE_xXHER2-expressing cancer as follows: Part 1: Any locally advanced (unresectable) and/or metastatic HER2-expressing (HER2 1+, 2+, or 3+ by IHC) cancer that has progressed after receipt of all therapies known to confer clinical benefitXx_NEWLINE_xXHER2-overexpressing (3+ by IHC) or HER2 2+ and FISH positive breast cancer must have progressed after prior treatment with trastuzumab, pertuzumab, and T?DM1Xx_NEWLINE_xXHER2-overexpressing (3+ by IHC) or HER2 2+ and FISH positive gastric cancer must have progressed after prior treatment with trastuzumab Part 2: ? Locally advanced (unresectable) and/or metastatic cancer that has progressed after receipt of all therapies know to confer clinical benefit (unless ineligible to receive a specific therapy) as follows:Xx_NEWLINE_xXCohort 1: HER2 IHC 2+/FISH negative breast cancerXx_NEWLINE_xXCohort 2: HER2 IHC 3+ or HER2 IHC 2+/FISH positive breast cancerXx_NEWLINE_xXCohort 3: HER2 IHC 2+/FISH negative gastric/GEJ cancerXx_NEWLINE_xXCohort 4: HER2 IHC 3+ or HER2 IHC 2+/FISH positive gastric/GEJ cancerXx_NEWLINE_xXCohort 5: Any other HER2 IHC 3+ or FISH positive cancerXx_NEWLINE_xXHER2 IHC 1+ or IHC2+/FISH- breast cancer patients who have received at least 1 and no more than 3 prior systemic chemotherapy regimensXx_NEWLINE_xXHER2 IHC 3+ or IHC 2+/FISH+ breast cancer patients who have received prior therapy with trastuzumab, pertuzumab, and T-DM1, at least 1 and no more than 3 prior systemic chemotherapy regimensXx_NEWLINE_xXHER2 IHC 2+ or 3+ FISH+ or FISH- gastric/GEJ cancer patients who have received at least 1 and no more than 3 prior systemic chemotherapy regimens.Xx_NEWLINE_xXInvasive breast cancer between 0.5 cm and 5 cm in size diagnosed by needle core biopsy, estrogen receptor positive (ER+) or estrogen receptor negative (ER-), Her2neu positive or negative, tumor grade 2 or 3Xx_NEWLINE_xXTriple-negative breast cancer (defined as estrogen receptor [ER] and progesterone receptor [PR] < 10% positive; HER2 0-1+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] ratio < 2.0)Xx_NEWLINE_xXHistologically confirmed estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor 2 (HER2)-negative adenocarcinoma of the breast with measurable metastatic or locally advanced diseaseXx_NEWLINE_xXKnown HER2-, ER-positive, or PR-positive breast cancer by local laboratory assessmentXx_NEWLINE_xXPatients enrolling in the triple negative breast cancer (estrogen receptor negative [ER-]/progesterone receptor negative [PR-]/human epidermal growth factor receptor 2 negative [Her2-]) group, cohort 3, must have a negative family history of HBOC syndrome, or negative gBRCA1/2m test; a family history of HBOC is defined by National Comprehensive Cancer Network (NCCN) Genetic/Familial High-Risk Assessment: Breast and Ovarian guidelineXx_NEWLINE_xXTriple negative (ER-/PR-/HER2-) (Note: This group of patients must have received at least 1 and up to 3 prior chemotherapy regimens in the advanced setting.)Xx_NEWLINE_xXPART I: Adults with malignant soft tissue and bone tumors and recurrent or progressive, metastatic solid tumors who have progressed on standard therapies with known benefit but for whom anti-HER2 therapy is not clinically indicated:\r\n* Patients with ovarian, cervical, colon, gastric/gastroesophageal junction, non-small cell lung, renal cell, bladder, malignant soft tissue and bone tumor, prostate cancer or other solid tumors that is known to be HER2 1+, 2+ or 3+ by immunohistochemistry (IHC) OR have a Vysis fluorescent in situ hybridization (FISH) result >= 1.8\r\n* Patients with breast cancer that is known to be HER2 1+ or 2+ by IHC or with a Vysis FISH result of 1.8 - < 2.2Xx_NEWLINE_xXPART II: Patients with breast cancer, gastric, gastroesophageal junction or other caners with 1+ to 3+ HER2/neu expression by IHC or a Vysis FISH result > 2.2Xx_NEWLINE_xXPhase II: Patients must have histologically or cytologically confirmed adenocarcinoma of the breast associated with the following clinical stage: IIB, IIIA, IIIB, or IIIC (see AJCC staging criteria, 7th edition); the tumor must be human epidermal growth factor receptor 2 (Her2)/neu negative (by DAKO HercepTest, fluorescence based in situ hybridization [FISH], or other approved assay)Xx_NEWLINE_xXPart B2: Participants must have advanced, recurrent, or metastatic breast cancer that is refractory to aromatase inhibitors (AI) with either disease recurrence or disease progression; must be hormone receptor positive (HR+) and human epidermal growth factor receptor 2 (HER2)-negative; must be of postmenopausal status or beginning ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonistXx_NEWLINE_xXTumor negative for expression of hormone receptors (< 1%) and not over-expressing HER2 by immunohistochemistry (IHC) (0-1), or in case of IHC of 2, negative by fluorescence in situ hybridization (FISH) or by alternative gene testingXx_NEWLINE_xXConfirmation of HER2 positivity:\r\n* Phase I only: Patients with leptomeningeal disease from ependymomas, gliomas, and medulloblastoma will be eligible for phase I but are not required to have HER2 analysis; HER2 testing is only required for breast cancer patients with leptomeningeal metastases; HER2 positive (immunohistochemistry [IHC] 3+ and/or FISH positive; IHC 2+ HER2 patients are eligible with reflex FISH positive testing with the ratio >= 2.0) breast cancer patients with leptomeningeal metastases by magnetic resonance imaging (MRI) or CSF (if MRI is negative) are eligible\r\n* Phase II only: ALL patients with HER2+ cancers of other histology will be allowed to enroll in phase II if they have leptomeningeal disease\r\n* NOTE: review will be performed for cases not reviewed at the participation institution for confirmation, but will not preclude patients from entering the trial (pathology report showing HER2 positivity is sufficient for registration)Xx_NEWLINE_xXHistologically confirmed metastatic triple negative breast cancer with measurable disease by RECIST 1.1 criteria hormone receptor (HR) defined as positive for the purposes of this study, if expression of estrogen receptor (ER) and/or progesterone receptor (PR) expression is greater than 10% by immunohistochemistry (IHC) and HER2 negative or non-amplified is determined by the current American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) criteria, which are as follows: HER2 testing by IHC as 0 or 1+. If HER2 is 2+, ISH (in situ hybridization) must be performed.Xx_NEWLINE_xXClinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is:\r\n* ER/progesterone receptor (PR)-positive (> 1% cells) by immunohistochemistry (IHC) and HER2 negative per American Society of Clinical Oncology (ASCO) guidelines (by IHC or fluorescence in situ hybridization [FISH])\r\n* Previously exposed to an aromatase inhibitor (AI) or a selective estrogen-receptor modulator/ downregulator (SERM; SERD) + a CDK4/6 inhibitor\r\n* Appropriate candidates for chemotherapy\r\n* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria that has not been previously irradiated and which can be followed by computed tomography (CT) or magnetic resonance imaging (MRI).\r\n* Amenable to biopsy at the time of study entry.Xx_NEWLINE_xXMetastatic triple negative breast cancer (TNBC), as defined by: \r\n* Estrogen receptor (ER) and progesterone receptor (PR) negative as defined as ER < 10% and PR < 10% by immunohistochemistry according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for hormone receptor testing\r\n* Human epidermal growth factor receptor 2 (HER2) non-amplified per ASCO/CAP guidelines, defined as: \r\n** immunohistochemistry (IHC) score 0/1+\r\n** IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells; or\r\n** ISH non-amplified with a ratio of HER2 to chromosome enumeration probe 17 (CEP17) < 2.0, and if reported, average HER2 gene copy number < 4 signals/cellsXx_NEWLINE_xXHas confirmed HR+ and HER2 negative breast cancer with known metastatic disease. HR defined as positive if expression greater than 10% by immunohistochemistry (IHC). HER2 negative or non-amplified is determined by the current American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) criteria which are as follows: HER2 testing by IHC as 0 or 1+. If HER2 is 2+, ISH (in situ hybridization) must be performed. HER2 is positive if: i. IHC 3+ based on circumferential membrane staining that is a. complete, intense ii. ISH positive based on: a. single-probe average HER2 copy number >= 6.0 signals/cell. b. Dual-probe HER2/CEP17 ratio >= 2.0 with an average HER2 copy number >= 4.0 signals/cell c. Dual-probe HER2/CEP17 ratio >= 2.0 with an average HER2 copy number < 4.0 signals/cell d. Dual-probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number >= 6.0 signals/cell.Xx_NEWLINE_xXHER2-positive gastric/GEJ cancer must have received prior trastuzumab, cisplatin (or carboplatin or oxaliplatin or investigational platinum agent) and 5-fluorouracil (5-FU)/capecitabine HER2-Positive Solid Tumor Specific Inclusion CriteriaXx_NEWLINE_xXCOHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Patients must have histologically confirmed persistent or recurrent invasive metastatic hormone receptor positive, HER2 normal breast cancer for which standard curative measures do not exist or are no longer effective; hormone receptor positive is defined as estrogen receptor (ER) positive >= 10% by immunohistochemistry (IHC) and/or progesterone receptor (PR) positive >= 10% by IHC; HER2 will be considered negative per American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines (HER2 test result as negative if a single test (or both tests) performed show: 1) IHC 1+ as defined by incomplete membrane staining that is faint/barely perceptible and within >10% of the invasive tumor cells; 2) IHC 0 as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within =< 10% of the invasive tumor cells; or 3) in situ hybridization (ISH) negative based on: a) single-probe average HER2 copy number < 4.0 signals/cell or b) dual-probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number < 4.0 signals/cell)and HER2 testing must have been performed in a laboratory accredited by the College of American Pathologists (CAP) or another accrediting entityXx_NEWLINE_xXCOHORT 2: TRIPLE NEGATIVE BREAST CANCER: Patients must have histologically or cytologically confirmed persistent or recurrent invasive, metastatic triple negative breast cancer (TNBC) for which standard curative measures do not exist or are no longer effective; TNBC, defined as ER negative (ER < 10%), PR negative (PR < 10%); HER2 will be considered negative per ASCO-CAP guidelines (HER2 test result as negative if a single test (or both tests) performed show: 1) IHC 1+ as defined by incomplete membrane staining that is faint/barely perceptible and within > 10% of the invasive tumor cells; 2) IHC 0 as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within =< 10% of the invasive tumor cells; or 3) ISH negative based on: a) single-probe average HER2 copy number < 4.0 signals/cell or b) dual-probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number < 4.0 signals/cell) and HER2 testing must have been performed in a laboratory accredited by the College of American Pathologists (CAP) or another accrediting entityXx_NEWLINE_xXPatients must have histologically confirmed clinical stage II or III estrogen receptor negative (ER-) progesterone receptor (PR) - HER2 positive (+) (per College of Pathologists [CAP] criteria) invasive ductal carcinoma of the breastXx_NEWLINE_xXEstrogen receptor (ER) and progesterone receptor (PR) < Allred score of 3 or =< 5% positive staining cells in the invasive component of the tumor (provided the patient is being treated as triple negative breast cancer)Xx_NEWLINE_xXHuman epidermal growth factor receptor 2 (HER2) negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+ according to National Comprehensive Cancer Network (NCCN) guidelinesXx_NEWLINE_xXDocumentation of estrogen receptor positive ((ER+), human epidermal growth factor receptor 2 (HER2 negative (HER2-)) tumor.Xx_NEWLINE_xXHistologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer based on the most recently available tumor biopsy collected from the patient. Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative.Xx_NEWLINE_xXTumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (<5%), any HER2 status, or MammaPrint Low, ER positive, HER2/neu positive by any one of the three methods used (IHC, FISH, TargetPrint™)Xx_NEWLINE_xXHistory of biopsy-proven HER2-overexpressing breast cancer and radiographic evidence of metastatic disease, or locally recurrent unresectable disease; the HER2 status can be determined either by immunohistochemistry (IHC) (IHC score, 3+) or by fluorescence in situ hybridization (FISH) (as defined by HER2/CEP-17 ratio >= 2.0, or HER2 copy number >= 6); patients must have received prior trastuzumab, independent of response to prior trastuzumab, and a taxane (in any disease setting, e.g. neo-adjuvant, adjuvant, metastatic)Xx_NEWLINE_xXTumor must be estrogen receptor and/or progesterone receptor positive (i.e hormone receptor positive [HR+] and HER-2 negative as defined by the American Society of Clinical Oncology/College of American Pathologists [ASCO-CAP] guidelines: HR+ is defined as expression of ER and/progesterone receptor [PR] in >= 1% of cells, or HR+ by local laboratory or regional definition; HER2? is defined as a HER2 immunohistochemistry [IHC] score of 0 or 1+, or an IHC score of 2+ accompanied by a negative fluorescence, chromogenic, or silver in situ hybridization test indicating the absence of HER2 gene amplification, or a HER2/CEP17 ratio of < 2.0, or local clinical guidelinesXx_NEWLINE_xXCore biopsy proven estrogen negative (< 1%), progesterone negative (< 1%), and HER2-neu negative (+1 by immunohistochemistry and/or fluorescence in situ hybridization [FISH] ratio < 2.0) invasive breast cancerXx_NEWLINE_xXHuman epidermal growth factor 2 (HER2) positive and estrogen receptor (ER) or progesterone receptor (PR) positive tumors: must be refractory to hormonal therapy (e.g. aromatase inhibitor, tamoxifen or fluvestrant) and previously treated with at least 2 regimens containing at least two anti-HER2 agents (e.g. trastuzumab and pertuzumab).Xx_NEWLINE_xXHER2 negative and either ER or PR positive tumors: must be refractory to hormonal therapy (e.g. aromatase inhibitor, tamoxifen or fulvestrant) and previously treated with at least 2 chemotherapy containing regimens.Xx_NEWLINE_xXHER2 positive and ER and PR negative tumors: must have failed at least 2 regimens containing at least two anti-HER2 agents (e.g. trastuzumab and pertuzumab).Xx_NEWLINE_xXEstrogen-receptor and progesterone-receptor expression both < 10% by immunohistochemistry (IHC) and HER2 negative by IHC or non-amplified as determined by the current American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) criteria; if patient has more than one histological result, the most recent one has to be considered for inclusionXx_NEWLINE_xXPatients must have HER2 status determined by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC); HER2 status of positive or negative are both eligible for the studyXx_NEWLINE_xXHER2-positive tumor status;Xx_NEWLINE_xXClinical stage IV or inoperable locoregional recurrent invasive mammary carcinoma that is:\r\n* ER+ and/or progesterone receptor (PgR)+ (>= 1% positive stained cells) by immunohistochemistry (IHC)\r\n* HER2-negative (by IHC or fluorescence in situ hybridization [FISH], per American Society of Clinical Oncology [ASCO] guidelines)\r\n* FGFR1, FGFR2, FGF3 or FGF4 amplified (may be determined by local assessment through either targeted capture next generation sequencing [NGS], plasma cell-free tumor [cf] DNA or FISH [in the case of FGFR1 amplifications]* in 50% of the patients participating in the expansion cohort of the trial [not necessary in the escalation cohort])\r\n** Cases will be considered as FGFR1-positive (‘amplified’) under one of the following conditions:\r\n*** The FGFR1/CEN8 ratio is >= 2.0\r\n*** The average number of FGFR1 signals per tumor cell nucleus is >= 6\r\n* Evaluable (may have either measurable or non-measurable disease)Xx_NEWLINE_xXAny receptor status (estrogen receptor, progesterone receptor, HER2 receptor); patients who are hormone receptor (HR)+ should also no longer be candidates for hormonal-based therapy; patients who are HER2+ should have progressed on or no longer be candidates for available HER2 directed therapy; hormonal therapy must be stopped prior to day 1 of treatmentXx_NEWLINE_xXHave diagnosis of triple negative breast cancer (defined as estrogen receptor [ER] < 1% by immunohistochemistry [IHC], progesterone receptor [PR] < 1% by IHC, Her 2 negative by  American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines)Xx_NEWLINE_xXCOHORT 2 (HORMONE RECEPTOR POSITIVE [HR+])Xx_NEWLINE_xXHave a diagnosis of ER+ breast cancer (defined as ER > 1% by IHC)Xx_NEWLINE_xXPositive for HPV by p16 immunohistochemistry (IHC) or in situ hybridization (ISH).Xx_NEWLINE_xXDISEASE SPECIFIC EXPANSION COHORTS: Breast cancers patients enrolled on this study must have:\r\n* Metastatic or advanced (incurable and unresectable) HER2 negative breast cancer regardless of estrogen receptor status (both hormone receptor positive and triple negative patients are eligible)\r\n* Received hormonal therapy, as appropriate based on their hormone receptor status; hormone receptor positive patients who have not received endocrine therapy for recurrent/metastatic disease are eligible, permitted their physician feels they are not appropriate for first line endocrine therapy, for example for high risk visceral metastatic diseaseXx_NEWLINE_xXPatients must have either:\r\n*Hormone receptor (HR) negative and HER-2 negative (TNBC) metastatic breast cancer and have not received prior chemotherapy for metastatic disease and should have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line); demonstrated HER-2 negative MBC (0 or 1+ by immunohistochemistry [IHC] or non-amplified by fluorescence in situ hybridization [FISH]) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAPA) guidelines; Or\r\n* Histologically or cytologically confirmed estrogen receptor (ER) positive and HER-2 negative metastatic breast cancer are eligible if they have progressed on single agent or combination endocrine therapy (e.g. AI/palbociclib or everolimus) indicating an endocrine-refractory diseaseXx_NEWLINE_xXHistologically or cytologically confirmed HER2-positive (3+ by IHC or amplified by FISH) according to ASCO/CAP guidelines\r\n* Note: A HER2 result of 2+ by ICH is equivocal and requires a reflex test (same specimen using the alternative test) or new test (new specimen, if available, using same or alternative test)Xx_NEWLINE_xXAny estrogen receptor (ER), progesterone receptor (PR), HER2 statusXx_NEWLINE_xXEstrogen receptor (ER) and progesterone receptor (PR) less than Allred score of 3 or less than 1% positive staining cells in the invasive component of the tumorXx_NEWLINE_xXHER2 negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+Xx_NEWLINE_xXPatients must have histologically confirmed HER2-positive breast cancer for which standard curative measures do not exist or are no longer effective; HER2 testing must have been performed in a laboratory accredited by the College of American Pathologists (CAP) or another accrediting entityXx_NEWLINE_xXHistopathologically or cytologically documented TNBC or TN-IBC. Tumors must have been confirmed negative for ER and PR by IHC (<1% positive tumor nuclei, as per ASCO-CAP guideline recommendations) and negative for HER2 by IHC or fluorescent or chromogenic in situ hybridization (FISH or CISH). Patients with equivocal HER2 results by IHC should have their negativity status confirmed by FISH.Xx_NEWLINE_xXPatients must have histologically confirmed HER2-negative breast cancer (defined as immunohistochemistry [IHC] 0 or 1+ and/or fluorescence in situ hybridization [FISH] < 2.0), that is metastatic in stageXx_NEWLINE_xXSubjects must be estrogen receptor (ER) positiveXx_NEWLINE_xXHormone receptor positive (defined as estrogen receptor [ER] and/or progesterone receptor [PR] positive), HER2 negative breast cancer that is clinically staged II-III with no known metastatic disease. ER and/or PR defined as positive if expression > 10% by immunohistochemistry (IHC). HER2 negative or non-amplified as determined by the current American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) criteria which are as follows: HER2 testing by immunohistochemistry (IHC) as 0 or 1+. If HER2 is 2+, ISH (in situ hybridization) must be performed. HER2 is positive if: IHC 3+ based on circumferential membrane staining that is complete, intense ISH positive based on: 1) Single-probe average HER2 copy number >= 6.0 signals/cell, 2) Dual-probe HER2/CEP17 ratio >= 2.0; c,e with an average HER2 copy number >= 4.0 signals/cell, 3) Dual-probe HER2/CEP17 ratio >= 2.0; c,e with an average HER2 copy number < 4.0 signals/cell, 4) Dual-probe HER2/CEP17 ratio < 2.0; c,e with an average HER2 copy number >= 6.0 signals/cellXx_NEWLINE_xXEither the primary tumor and/or metastatic tumor must be triple-negative as defined below:\r\n* Hormone receptor status: the invasive tumor must be estrogen receptor (ER)- and progesterone receptor (PR) negative, or staining present in < 1% by immunohistochemistry (IHC)\r\n* HER2 status: the invasive tumor must be human epidermal growth factor receptor 2 negative (HER2-negative) by the American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines\r\n* In cases where both primary tumor and metastatic sample(s) have been tested for ER, PR, and HER2, then the triple-negative status of the tumor should be determined from the most recent sample availableXx_NEWLINE_xXTumor is hormone receptor (HR)+ (estrogen receptor and/or progesterone receptor positive with at least 10% expression of either receptor by local immunohistochemical staining) and HER2 negative based on local assessmentXx_NEWLINE_xXWomen diagnosed with pathologically confirmed HER2-overexpressing breast cancer, that is locally recurrent, unresectable or metastatic (negative or positive for ER/PR, and positive for HER2)Xx_NEWLINE_xXHER2 status confirmed positive by means of immunohistochemistry (IHC) or in situ hybridization (ISH) according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) 2013 guidelines; it is considered positive if scored as 3+ by an IHC method defined as uniform membrane staining for HER2 in 10% or more of tumor cells or demonstrate HER2 gene amplification by an ISH method (single probe, average HER2 copy number >= 6.0 signals/cell; dual probe HER2/CEP17 ratio >= 2.0 with an average HER2 copy number >= 4.0 signals/cell; dual probe HER2/chromosome enumeration probe (CEP)17 ratio >= 2.0 with an average HER2 copy number < 4.0 signals/cell; HER2/CEP17 ratio < 2.0 with an average HER2 copy number >= 6.0 signals/cell)Xx_NEWLINE_xXConfirmed invasive triple-negative breast cancer defined as estrogen receptor (ER) < 10%; progesterone receptor (PR) < 10% by immunohistochemistry (IHC) and HER2 0-1+ by IHC or 2+, fluorescence in situ hybridization (FISH) < 2, gene copy number < 4Xx_NEWLINE_xXCohort 1: Phase 1b: subject must have HER2 + (regardless of hormonal receptor status) primary metastatic or locally advanced breast cancer (IBC or Non-IBC); HER2 positive status is defined as strongly positive (3+) staining score by immunohistochemistry (IHC), or gene amplification using fluorescence in situ hybridization (FISH), if performed; if IHC is equivocal (2+), assays using FISH require gene amplification based on recent American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guideline: dual-probe HER2/CEP17 ratio is >= 2.0 and/or an average HER2 copy number >= 6.0 signals/cell; IBC is determined by using international consensus criteria: onset: rapid onset of breast erythema, edema and/or peau d’orange, and/or warm breast, with/without an underlying breast mass; duration: history of such findings no more than 6 months; extent erythema occupying at least 1/3 of whole breast; pathology: pathologic confirmation of invasive carcinomaXx_NEWLINE_xXCohort 1: Phase II: patient must have HER2+ (regardless of hormonal receptor status) stage III IBCXx_NEWLINE_xXCohort 2 patient must have HER2-/HR+ stage III IBC; HER2 negative status, which determined by assays using IHC require negative (0 or 1+) staining score; if IHC is equivocal (2+) staining score, assays using FISH require the absence of gene amplification: dual-probe HER2/CEP17 ratio is < 2.0 and an average HER2 copy number < 4.0 signals/cell; if HER2 testing result is confirmed at M D Anderson Cancer Center (MDACC), it does not require centralized repeat testing; hormone receptor (HR) positivity is determined by estrogen receptor (ER) >= 10% and /or progesterone receptor (PR) >= 10% by IHC stainingXx_NEWLINE_xXQualifying risk status, at diagnosis utilizing receptor testing by American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, meeting one of the following:\r\n* Histologically positive axillary lymph nodes\r\n* Primary tumor that is estrogen receptor (ER)/progesterone receptor (PR)/Her2 negative\r\n* Primary tumor that is ER+/Her2 negative/lymph node negative with Breast Cancer Recurrence Score of >= 25 per the Genomic Health Oncotype diagnosis (DX) breast cancer test\r\n* Evidence of residual disease in the breast on pathological assessment after neoadjuvant chemotherapyXx_NEWLINE_xXPatients must have histologically confirmed hormone receptor positive (ER and/or progesterone receptor [PR]), human epidermal growth factor receptor 2 (HER2) negative, early invasive breast cancer; ER, PR and HER2 measurements should be performed according to institutional guidelines, in a Clinical Laboratory Improvement Amendments (CLIA)-approved setting in the United States (US) or certified laboratories for non-US regions; cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines; central confirmation is not required for ER, PR, or HER statusesXx_NEWLINE_xXPatients with equivocal HER2 in situ hybridization results according to current ASCO/CAP guidelines are allowed, as long as the clinician has determined that they should be treated as HER2 negativeXx_NEWLINE_xXPatients with multifocal or multi-centric disease are eligible if the treating clinician has determined the patient should be treated as ER+ and HER2- negativeXx_NEWLINE_xXBilateral breast cancers are allowed if the treating clinician has determined the patient should be treated as ER+ and HER2- negativeXx_NEWLINE_xXDocumented HER2 mutation.Xx_NEWLINE_xXPatients/subjects with HER2 positive tumor that have not been treated with trastuzumab prior to enrollmentXx_NEWLINE_xXMost recent tumor biopsy or surgical resection specimen must be either estrogen receptor (ER) positive, progesterone receptor (PgR) positive, or both, as defined by immunohistochemistry (IHC) >= 1% (as per the American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)Xx_NEWLINE_xXHuman epidermal growth factor receptor 2 (HER2)-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+; if IHC is 2+ (i.e. indeterminate), a negative in situ hybridization (fluorescence in situ hybridization [FISH], chromogenic in situ hybridization [CISH], or silver in situ hybridization [SISH]) test is required by local laboratory testing; (as per the ASCO-CAP guidelines)Xx_NEWLINE_xXPatients must have histologically confirmed, metastatic or unresectable malignancy of the following types: (a) non-small cell lung cancer (NSCLC), (b) triple-negative breast cancer (TNBC; defined by estrogen receptor [ER] < 1%, progesterone receptor [PR] < 1% and HER2 1+ or less by immunohistochemistry [IHC]; if HER-2 expression is 2+, a negative fluorescence in situ hybridization [FISH] testing is required) (c) pancreatic adenocarcinoma (PDAC), or (d) small cell lung cancer (SCLC)Xx_NEWLINE_xXHistological confirmation of triple negative breast cancer defined as:\r\n* Her2/neu by fluorescence in situ hybridization (FISH) (ratio =< 1.8) or immunohistochemistry (IHC) (0 or 1+)\r\n* Estrogen receptor (ER) and progesterone receptor (PR) expression < 10%Xx_NEWLINE_xXKnown ER, PgR and HER2 statuses.Xx_NEWLINE_xXHistologically proven invasive breast carcinoma with triple negative receptor status (estrogen receptor, progesterone receptor and HER2 negative by immunohistochemistry [IHC] and/or fluorescence in situ hybridization [FISH]); patients who are weekly positive for the estrogen or progesterone receptor (i.e. =< 10%) are eligibleXx_NEWLINE_xXIs HER2 normal, defined as HER2 0 or 1+ by immunohistochemistry (IHC) and negative by fluorescence in situ hybridization (FISH) if performed; or HER2 is 2+ by IHC and negative by FISH; or HER2 negative by FISH if IHC is not performed.Xx_NEWLINE_xXHas positive estrogen receptor (ER) or progesterone receptor (PR) status. ER or PR >= 10%.Xx_NEWLINE_xXHave documented testing for human epidermal growth factor receptor 2 (HER2-neu) overexpressing, and for those with tumors overexpressing HER2-neu, have documented progression on Trastuzumab-containing therapyXx_NEWLINE_xXBreast cancer determined to be HER2-negative per current American Society of Clinical Oncologists/College of American Pathologists (ASCO/CAP) HER2 guidelines (if immunohistochemistry [IHC] was performed, IHC 0 or 1+; if fluorescence in situ hybridization [FISH] or other in situ hybridization test, dual probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number < 4.0 signals/cell)Xx_NEWLINE_xXBreast cancer determined to be hormone receptor-positive or hormone receptor-negative defined as follows:\r\n*  Hormone receptor-positive: >= 10% staining by IHC for either estrogen receptor (ER) or progesterone receptor (PgR)\r\n* Hormone receptor-negative: < 10% staining by IHC for both ER and PgRXx_NEWLINE_xXEstrogen receptor (ER)+ Her2- breast cancerXx_NEWLINE_xXEstrogen receptor (ER)+ Her2- breast cancerXx_NEWLINE_xXHER2 positive (immunohistochemistry [IHC] 3+ and or fluorescence in situ hybridization [FISH] amplified) or triple receptor negative (triple negative [TN], estrogen receptor [ER]/progesterone receptor [PR] < 10% HER2 negative [IHC 1+ or 2+ FISH non-amplified]) receiving any standard routine clinical NST regimenXx_NEWLINE_xXPatient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.Xx_NEWLINE_xXPatient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.Xx_NEWLINE_xXNew diagnosis of invasive cyclin D1 +, estrogen receptor (ER)+, progesterone receptor (PR) +/-, Her2- breast cancer\r\n* Cyclin D1 positive as defined as a total immunohistochemical score of 5 or greater\r\n* Hormone receptor positive as defined as >= 10% positive stained cells\r\n* HER2-normal (immunohistochemistry [IHC] score 0-1 or fluorescence in situ hybridization [FISH] negative [in-situ hybridization (ISH) ratio =< 2.0 status])Xx_NEWLINE_xXIndeterminate or negative HER2 statusXx_NEWLINE_xXPatients must have a metastatic tumor negative for HER2; the lack of HER2 overexpression by immunohistochemistry (IHC), is defined as 0 or 1+ whereas hyperexpression is defined as 3+; if equivocal IHC, 2+, the tumor must be non-gene amplified by fluorescence in situ hybridization (FISH) performed upon the primary tumor or metastatic lesion (ratio < 2 and HER2 copy number < 4)Xx_NEWLINE_xXPatients must have negative HER2 expression on immunohistochemistry (IHC) (defined as 0 or 1+) or fluorescence in situ hybridization (FISH) analysis; if HER2 is 2+, negative HER2 expression must be confirmed by FISH (HER2/cep17 ration < 2, and/or copy number less than 6); ER and PgR expression should be less than 10%Xx_NEWLINE_xXHave at least 2 of the following high risk features associated with her DCIS-high grade (grade II-III), palpable mass, hormone receptor negative (less than 1%), Her2 positive, young age (less than 45 years old), and large size (greater than 5 cm)Xx_NEWLINE_xXHistory of ER positive (+) (>= 10% of cells positive on hematoxylin and eosin stain [H&E]), HER2 negative (?) breast cancer disease, either as a\r\n* History of primary, operable ER+/HER2? invasive breast cancer OR\r\n* History of de novo metastatic breast cancer that is ER+/HER2?\r\n** Note: HER2? (negative) disease defined as one of the following:\r\n*** HER2 immunohistochemistry (IHC) expression of 0, 1+ and in-situ hybridization (ISH) non-amplified\r\n*** HER2 IHC expression of 0, 1+ and ISH not done\r\n*** HER2 IHC expression of 2+ and ISH non-amplified\r\n*** IHC not done and ISH non-amplified; Note: supporting documentation such as a pathology report from their primary diagnosis that indicates ER+/Her2- invasive breast cancer or a biopsy report of de novo metastatic breast cancer that is ER+/HER2? should be submitted through the RAVE databaseXx_NEWLINE_xXThe current cancer must over express HER2 as determined by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)Xx_NEWLINE_xXHistologically confirmed adenocarcinoma of the breast that is Her2 negative (by DAKO Herceptest, fluorescence in situ hybridization [FISH], or other approved assay)Xx_NEWLINE_xXExpress at least 1 of the hormone receptors [HR; estrogen receptor (ER) or progesterone receptor (PR)] by immunohistochemistry (IHC) to fulfill the requirement for HR+ disease on the primary tumor or metastatic lesion of the breast cancer. ER and PR assays are considered positive if there is at least 1% positive tumor nuclei in their sample as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) or local guidelines.Xx_NEWLINE_xXTo fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization (ISH) as defined in the relevant ASCO/CAP or local guidelines.Xx_NEWLINE_xXMost recent HR and HER2 receptor testing should be used to determine eligibility.Xx_NEWLINE_xXPatients must have histologically or cytologically confirmed clinical stage T2-3 N0-2 triple negative (estrogen receptor/progesterone receptor < 1% HER2 0-1 by immunohistochemistry [IHC] or unamplified by fluorescence in situ hybridization [FISH]) invasive ductal carcinomaXx_NEWLINE_xXPrimary, invasive, estrogen receptor (ER) and/or progesterone receptor (PR)-positive, HER2 negative breast cancer; ER-and/or PR–positive breast cancer is defined by > 10% staining by immunohistochemistryXx_NEWLINE_xXHave histologically confirmed adenocarcinoma of the breast that is either TNBC or HR positive/HER-2 negative; TNBC is defined as: estrogen receptor (ER)/progesterone receptor (PR) < 1% and HER-2 negative disease (Immunohistochemistry [IHC] 0-1+ or 2+ with HER2/17 ratio on Fluorescence In Situ Hybridization [FISH] =< 1.8) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; HR positive is defined as: ER/PR >= 1% and HER-2 negative as per ASCO/CAP guidelinesXx_NEWLINE_xXDocumentation of the following receptors based on local testing from most recent assessment:\r\n* ER-positive and/or PR-positive tumor (>= 1% positive stained cells)\r\n* HER2-negative tumor; NOTE: HER2-negative is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (FISH/CISH/SISH) defined as a HER2/CEP17 ratio < 2, for single probe assessment a HER2 copy number < 6 or per current American Society Clinical Oncologists (ASCO)-College of American Pathologists (CAP) or National Comprehensive Cancer Network (NCCN) guidelinesXx_NEWLINE_xXPatients must have histologically or cytologically confirmed stage I-III triple negative breast cancer\r\n* Estrogen receptor (ER) and progesterone receptor (PR) must be < 10% by standard assay methods\r\n* Human epidermal growth factor receptor 2 (HER2) must be either 0, 1+ by immunohistochemistry (if 2+, in situ hybridization method used to define HER2) OR have HER2: 17 centromere signal of < 2.0 using a standard in situ hybridization methodXx_NEWLINE_xXDose Expansion Cohort Group 1 and 2: Patients must have a diagnosis of histologically confirmed metastatic TNBC defined as negative for estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2 (HER2); patients must have received either adjuvant chemotherapy or first line chemotherapy for metastatic disease; negative for estrogen and progesterone receptor includes the following:\r\n* Local pathology report classifies them as negative\r\n* Allred score of 2 or below\r\n* < 1% positive stainingXx_NEWLINE_xXINCLUSION CRITERIA FOR TNBC: Histologically confirmed diagnosis of metastatic TNBC; i.e. breast cancer that is estrogen receptor (ER) negative (=< 10%), progesterone receptor (PR) negative (=< 10%), and human epidermal growth factor receptor 2 (HER2) negative (0 or 1+ by immunohistochemistry or negative for gene amplification by fluorescence in situ hybridization [FISH])Xx_NEWLINE_xXEstrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor (? 1% positive stained cells) based on local laboratory resultsXx_NEWLINE_xXHER2-negative breast cancer based on local laboratory results (test to be used as per local practice); HER2-negative tumor is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (fluorescence in situ hybridization [FISH]/chromogenic in situ hybridization [CISH]/silver-enhanced in situ hybridization [SISH]) defined as a HER2/CEP17 ratio < 2 or for single probe assessment a HER2 copy number < 4Xx_NEWLINE_xXPatients must have triple-negative breast cancer defined as estrogen receptor (ER) < 10%; progesterone receptor (PR) < 10% by immunohistochemistry (IHC) and human epidermal growth factor receptor 2 (HER2) 0-1+ by IHC or 2+, fluorescence in situ hybridization (FISH) non-amplifiedXx_NEWLINE_xXFor cohorts 2, 3, 4, documented HER2 amplification identified through next generation sequencing by Memorial Sloan-Kettering Cancer Center (MSK)-Integrated Mutation Profiling for Actionable Cancer Targets (IMPACT) or at another Clinical Laboratory Improvement Amendments (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH) with HER2/ centromeric probe for chromosome 17 (CEP17) ratio >= 2.0 at a CLIA laboratory; patients with HER2 amplification identified by another method or criteria must be approved by the principal investigator and may enroll in the “other” cohort 4Xx_NEWLINE_xXClinical stage IV invasive mammary carcinoma that is estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2) negative (triple negative) previously documented by conventional methods (immunohistochemistry [ISH], fluorescence in situ hybridization [FISH]); ER negative is defined as expression of ER in =< 5% cells, PR negative is defined as expression of PR in =< 5% cells, HER2 negative (acceptable methods of HER2 analysis include IHC [0, 1+], fluorescence in situ hybridization [FISH] with HER2/chromosome 17 centromere [CEN-17] ratio < 2, and/or chromogenic in situ hybridization [CISH] with HER2/CEN-17 ratio < 2), as previously documented by histological analysisXx_NEWLINE_xXMinimum number of prior treatments required given standard nab-paclitaxel dosing:\r\n* If HER2 negative: none; Note: Subjects with hormone-receptor positive tumors (estrogen receptor positive [ER+] and/or progesterone receptor positive [PR+]) must have failed available appropriate lines of hormonal therapy (eg, ovarian suppression or ablation, selective estrogen receptor modulators, aromatase inhibitors, estrogen receptor antagonists, etc), unless intolerant to hormonal therapy or hormonal therapy is not considered to be clinically appropriate\r\n* If HER2 positive: two prior regimens containing HER2 targeted therapies in the inoperable locally advanced and/or metastatic setting; prior therapy for inoperable locally advanced/metastatic disease should include trastuzumab plus pertuzumab as well as ado-trastuzumab; pertuzumab and ado-trastuzumab must have been previously used, unless for reasons that include, but are not limited, to the following: intolerance to pertuzumab and/or ado-trastuzumab, medical contraindication, regimen declined by patient, treating investigator discretion, or medical insurance coverage issues which prevented administration of pertuzumab or ado-trastuzumab; these reasons must be reviewed with the study chairs and documented in the medical record and care report form; patients who relapse within 12 months of completing neoadjuvant/adjuvant pertuzumab or ado-trastuzumab would be considered as having progressed on that regimen\r\n* There is no maximum number of prior treatments allowed in the metastatic settingXx_NEWLINE_xXBreast cancer determined to be estrogen receptor (ER)-negative and progesterone receptor (PgR)-negative defined for this study as < 10% tumor staining by immunohistochemistry (IHC)\r\n* Note: Eligibility should be based on the ER and PgR status reported at the time of the most recent biopsy or resectionXx_NEWLINE_xXBreast cancer determined to be HER2-negative per current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) HER2 Guidelines\r\n* Note: Eligibility should be based on the HER2 status reported at the time of the most recent biopsy or resectionXx_NEWLINE_xXThe invasive cancer must be HER2-low, defined as immunohistochemistry (IHC) 0-1+, or with a fluorescence in situ hybridization (FISH) ratio of < 1.8 if IHC is 2+ or if IHC has not been performedXx_NEWLINE_xXThe invasive cancer must be estrogen receptor alpha (ER)-positive, defined as having ER staining by IHC in >= 10% of malignant tumor cellsXx_NEWLINE_xXPatient must have histologically or cytologically confirmed breast cancer that is now metastatic; any estrogen receptor (ER), progesterone receptor (PR) or human epidermal growth factor receptor 2 (HER2) status is allowedXx_NEWLINE_xXTriple-negative breast cancer defined as estrogen receptor (ER) < 10%; progesterone receptor (PR) < 10% by immunohistochemistry (IHC) and human epidermal growth factor receptor 2 (HER2) 0-1 positive (+) by IHC or 2+, fluorescence in situ hybridization (FISH) < 2, gene copy number < 4Xx_NEWLINE_xXEstrogen Receptor-positive pathologyXx_NEWLINE_xXPatients must have a histologically documented (either primary or metastatic site) diagnosis of breast cancer that is HER2 non-overexpressing by immunohistochemistry, namely 0 or 1; if they have an equivocal immunohistochemistry, 2, the tumor must be non-gene amplified by fluorescence in situ hybridization (FISH) performed upon the primary tumor or metastatic lesion (ratio < 2 and HER2 copy number < 4); estrogen receptor (ER) positivity is defined as 1% or greater; progesterone receptor (PR) positivity will be defined as a result of greater than 10%; documentation of ER and PR status should be available at registration; the expansion cohort will only include HER2-negative, ER and PR-negative patientsXx_NEWLINE_xXPatients with histologically confirmed diagnosis of locally-advanced, inoperable, metastatic and/or treatment-refractory triple negative breast cancer (TNBC). *Treatment refractory disease is defined as the persistence of tumor lesions following at least one intervention that may include chemotherapy, radiation and/or surgery, or any combination thereof. *Patients must have both ER and PR staining < 5% and be HER2-negative. Patients with ER or PR staining of 5-10%, but who have historically been treated as TNBC may also be enrolled. *Patients must not have disease that, in the opinion of the investigator, is considered amenable to potentially curative treatment.Xx_NEWLINE_xXEstrogen receptor (ER) and progesterone receptor (PR) expression both < 10% by immunohistochemistry (IHC) and human epidermal growth factor receptor 2 (HER2) negative or non-amplified as determined by the current American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) criteria which are as follows: HER2 testing by IHC as 0 or 1+; if HER2 is 2+, ISH (in situ hybridization) must be performed; HER2 is positive for gene amplification if: - IHC 3+ based on circumferential membrane staining that is complete, intense - ISH positive based on: \r\n* Single-probe average HER2 copy number >= 6.0 signals/cell\r\n* Dual-probe HER2/chromosome enumeration probe (CEP)17 ratio >= 2.0; with an average HER2 copy number >= 4.0 signals/cell\r\n* Dual-probe HER2/CEP17 ratio >= 2.0; with an average HER2 copy number < 4.0 signals/cell\r\n* Dual-probe HER2/CEP17 ratio < 2.0; with an average HER2 copy number >= 6.0 signals/cellXx_NEWLINE_xXHormone receptor positive and HER2 negative breast cancer; patients with HER2/neu positive tumors irrespective of their hormone receptor status will be excluded; at least 10% of tumor cell nuclei should be immunoreactive for hormone receptors (ER and/or PR) to be deemed eligible for the study; Her2/neu negative is defined as:\r\n* Immunohistochemistry (IHC) score of 0 (no staining is observed or membrane staining that is incomplete and is faint/barely perceptible and within =< 10% of tumor cells) OR\r\n* IHC score of 1 (incomplete membrane staining that is faint/barely perceptible and within < 10% of tumor cells) OR\r\n* Fluorescence in situ hybridization (FISH) HER2/chromosome enumeration probe 17 (CEP17) ratio of < 1.8 or average HER2 gene copy number of < 4 signals/nucleus for test systems without an internal control probe\r\n* Equivocal results for HER2/neu (defined as: IHC 2+ or FISH HER2/CEP17 ratio of 1.8-2.2 or average HER2 gene copy number 4-6 HER2 signals/nucleus for test systems without an internal control probe) should prompt reflex test (same specimen using an alternative method) or order a new test (new specimen if available, using IHC or FISH)Xx_NEWLINE_xXHER2/neu positive or estrogen and progesterone receptor negative breast cancer; patients with triple negative breast cancer are also excludedXx_NEWLINE_xXDocumentation of estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor (>= 1% positive stained cells) based on most recent tumor biopsy (unless bone-only disease, discuss with the Study Chair if results in different biopsies are discordant in terms of hormone receptor positivity) utilizing an assay consistent with local standardsXx_NEWLINE_xXDocumented human epidermal growth factor receptor 2 (HER2)-negative tumor based on local testing on most recent tumor biopsy: HER2-negative tumor is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (fluorescence in situ hybridization [FISH]/chromogenic in situ hybridization [CISH]/silver in situ hybridization [SISH]) defined as a HER2/centromeric probe for chromosome 17 (CEP17) ratio < 2 or for single probe assessment a HER2 copy number < 4Xx_NEWLINE_xXStage 1, 2 or 3 invasive breast cancer which is triple negative; triple negative breast cancer is defined as estrogen receptor (ER) < 1%, progesterone receptor (PR) < 1% and HER2 0 or 1+ or fluorescence in situ hybridization (FISH) not amplified if IHC 2+Xx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY)\r\nPatients must have histologically confirmed persistent or recurrent triple-negative breast cancer (TNBC) for which standard curative measures do not exist or are no longer effective; estrogen receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2 (HER2) status needs to be documented either by an outside source or at National Cancer Institute (NCI)Xx_NEWLINE_xXEstrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) (HER2 status is not required for women diagnosed with DCIS)Xx_NEWLINE_xXHER-2+ (HER2 status is not required for women diagnosed with DCIS)Xx_NEWLINE_xXER+ statusXx_NEWLINE_xXDisease must be ER+ and HER2-Xx_NEWLINE_xXFor phase 1b: HER2 negative, as defined for phase II; any ER/PR (negative or positive) can be enrolled in the phase 1b portionXx_NEWLINE_xXFor phase II: ER negative (defined as expression of ER in =< 1% cells), PR negative (defined as expression of PR in =< 1% cells), HER2 negative (acceptable methods of HER2 analysis include IHC [0, 1+], fluorescence in situ hybridization [FISH] with HER2/centromere on chromosome 17 [CEN17] ratio < 2, and/or chromogenic in situ hybridization [CISH] with HER2/CEN-17 ratio < 2), as previously documented by histological analysisXx_NEWLINE_xXConfirmed invasive triple-negative breast cancer defined as estrogen receptor (ER) < 10%; progesterone receptor (PR) < 10% by immunohistochemistry (IHC) and human epidermal growth factor receptor 2 (HER2) 0-1+ (by IHC), or 2+ (fluorescence in situ hybridization [FISH] < 2, gene copy number < 4)Xx_NEWLINE_xXAT THE TIME OF INFUSION: Recurrent or refractory HER2-positive GBM\r\n* Immunohistochemistry (IHC) or reverse transcriptase-polymerase chain reaction (RT-PCR) will be used to determine HER2 positivity; results will be compared to standard controls; HER2 expression in tumors on IHC should be ? grade 1 and ?1+ intensity score; wherein grades are defines as: grade 0: no staining; grade 1: 1-25%; grade 2: 26-50% and grade 3: 51-100% of cell staining for HER2 and intensity scores are: negative; 1+; 2+ and 3+ using breast cancer standard arrays as a guide for intensityXx_NEWLINE_xXAT THE TIME OF INFUSION: Available autologous transduced T lymphocytes with ? 15% expression of HER2 CAR determined by flow cytometry and killing of HER2-positive targets ? 20% in cytotoxicity assayXx_NEWLINE_xXKnown HER2 statusXx_NEWLINE_xXEstrogen receptor (ER) and progesterone receptor (PR) less than Allred score of 3 or less than 1% positive staining cells in the invasive component of the tumorXx_NEWLINE_xXHuman epidermal growth factor receptor 2 (HER2) negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+Xx_NEWLINE_xXHas histological confirmation of HER2 normal breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d’orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis of inflammatory breast cancer regardless estrogen receptor (ER)/progesterone receptor (PR) status; OR has histological confirmation of triple negative breast carcinoma (HER2 normal, ER/PR < 10%) without clinical diagnosis of IBCXx_NEWLINE_xXIs HER2 normal, defined as HER2 0 or 1+ by immunohistochemistry (IHC) and negative by fluorescence in situ hybridization (FISH) if performed; or HER2 is 2+ by IHC and negative by FISH; or HER2 negative by FISH if IHC is not performedXx_NEWLINE_xXHistologically confirmed metastatic or recurrent triple-negative (i.e. estrogen receptor =< 5%, progesterone receptor =< 5%, HER2-negative via immunohistochemistry [IHC] or fluorescent in situ hybridization [FISH] per American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guidelines 2013) breast cancerXx_NEWLINE_xXThe invasive cancer must have been confirmed to be human epidermal growth factor receptor 2 (HER2)-negative at some point in a given patient’s disease history (can be from any tumor specimen from a given patient, including archived primary, recurrent, or metastatic tumor), defined as immunohistochemistry (IHC) 0-1+, or with a fluorescent in situ hybridization (FISH) ratio of < 1.8 if IHC is 2+ or if IHC has not been performedXx_NEWLINE_xXPatients with HER2(-) statusXx_NEWLINE_xXEstrogen receptor negative - defined as less than or equal to 5% staining by immunohistochemistry (IHC)Xx_NEWLINE_xXProgesterone receptor negative - defined as less than or equal to 5% staining by IHCXx_NEWLINE_xXHuman epidermal growth factor receptor (HER) 2 negative defined as 0 or 1+ using IHC or a ratio of less than 2.0 on fluorescence in situ hybridization (FISH) testing; HER 2 of 2+ on IHC should have a ratio of less than 2.0 on FISH testing to be considered HER2 negativeXx_NEWLINE_xXEstrogen receptor (ER) and progesterone receptor (PR) less than Allred score of 3 or less than 1% positive staining cells in the invasive component of the tumor; patients not meeting this pathology criteria, but have been clinically treated as having triple negative breast cancer (TNBC), can be enrolled at principal investigator (PI) discretionXx_NEWLINE_xXHuman epidermal receptor 2 (HER2) negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+Xx_NEWLINE_xXWomen with previously untreated, unilateral stage II-III breast cancer, ER/PgR/HER2 negative (ER =< 5%, PgR =< 5%, HER2 0-1+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] =< 2.0); if clinically negative lymph nodes, tumor size should be minimum 1.0 cm and identifiable under office-based ultrasound guidanceXx_NEWLINE_xXPatients must have estrogen receptor (ER) analysis performed prior to study entry. If ER analysis is negative, then progesterone receptor (PgR) analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)Xx_NEWLINE_xXBreast cancer must be determined by local testing to be human epidermal growth factor receptor 2 (HER2)-positive prior to study entry using American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) HER2 test guidelines.Xx_NEWLINE_xXClinical T2-T4c, any N, M0 invasive estrogen receptor positive (ER+) (Allred Score of 6-8) and human epidermal growth factor receptor 2 negative (HER2-) (0 or 1+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] negative for amplification) breast cancer by American Joint Committee on Cancer (AJCC) 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node; patients with T1c tumors are eligible if they are considered candidates for neoadjuvant endocrine therapyXx_NEWLINE_xXCOHORT II: Core biopsy demonstrating breast cancer and receptors that are estrogen receptor (ER) or progesterone receptor (PR) positiveXx_NEWLINE_xXCOHORT II: Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsyXx_NEWLINE_xXPatients with progesterone receptor positive (PR+) tumors are allowedXx_NEWLINE_xXHuman epidermal growth factor receptor 2 (HER2) negative by fluorescent in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+Xx_NEWLINE_xXEstrogen receptor (ER) less than Allred score of 3 or less than 1% positive staining cells in the invasive component of the tumorXx_NEWLINE_xXClinically node negative, hormone receptor positive (+). HER2 negative (-), with <25% intraductal component in the aggregate.Xx_NEWLINE_xXPatients must have had histologically confirmed stage I-III breast carcinoma that is positive for estrogen receptor (ER) and/or progesterone receptor (PR)Xx_NEWLINE_xXHER2 positive breast cancer, defined by immunohistochemical staining for HER2 protein of 3+ intensity and/or amplification of the HER2 gene on fluorescence in situ hybridization (FISH) >= 2.0 on breast specimen or biopsy of a metastatic siteXx_NEWLINE_xXHER2 therapy naive or currently receiving non-lapatinib HER2 targeted therapyXx_NEWLINE_xXEstrogen receptor (ER), progesterone receptor (PR), and HER2/neu status documented by core needle biopsy of the primary tumor and/or regional lymph node must be known prior to beginning systemic therapyXx_NEWLINE_xXHER2 overexpression of tumor by either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH); tumors tested by IHC must be 3+ positive; tumors tested by FISH must have a ratio of HER2:CEP17 > 2.0; when both tests are performed, the FISH result must be positiveXx_NEWLINE_xXEstrogen and/or progesterone receptor positiveXx_NEWLINE_xXStep 2 subjects only: newly diagnosed, operable, triple negative breast cancer, i.e. estrogen receptor (ER)/progesterone receptor (PR)-negative, human epidermal growth factor receptor (her2)/neu-negative, with tumor size between 2–5 cm (T2) as measured by either clinical breast exam, mammogram, ultrasound or magnetic resonance imaging (MRI), with or without ipsilateral axilla node involvement (N0 or N1)Xx_NEWLINE_xXSubjects must not have been diagnosed with estrogen receptor negative (ER-) AND progesterone receptor negative (PR-) breast cancer (patients must have either an ER or PR positive status)Xx_NEWLINE_xXMust have ER positive disease with ER/PR report available.Xx_NEWLINE_xXFor tumors that are invasive, HER2 must be performed (positive or negative is acceptable).Xx_NEWLINE_xXHistologically documented metastatic or locally advanced unresectable breast cancer that is estrogen receptor (ER) and progesterone receptor (PR) < 10% expression and does not over-express HER2 protein (immunohistochemistry [IHC] 0, 1+, or 2+ and fluorescence in situ hybridization [FISH] < 2.0)Xx_NEWLINE_xXHER2-negative and hormone receptor-positive status (common breast cancer classification tests)Xx_NEWLINE_xXHave either human epidermal growth factor receptor 2 positive (HER2+) (Study Part A) or HER2- (Study Part B) breast cancer.Xx_NEWLINE_xXPatients with histologically confirmed adenocarcinoma of the breast that does not over-express HER-2/neu; this is defined as fluorescent in situ hybridization (FISH) negative, or 0, 1+ or 2+ by immunohistochemistry (IHC); IHC 2+ tumors must be FISH negative with an amplification ratio of less than 2.0; patients must not be eligible for therapy of known curative potential for metastatic breast cancer if it is identified during the course of the studyXx_NEWLINE_xXDiagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive sarcoma, not treatable by surgical resectionXx_NEWLINE_xXDiagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive sarcoma, not treatable by surgical resection and with disease progression after receiving at least one prior systemic therapyXx_NEWLINE_xXAvailable autologous transduced cytotoxic T lymphocytes with >= 15% expression of HER2 CAR and killing of HER2-positive targets >= 20% in cytotoxicity assayXx_NEWLINE_xXMust have histologically or cytologically confirmed triple negative (estrogen receptor [ER]-/progesterone receptor [PR]-/HER2-) or estrogen poor invasive breast cancer\r\n* NOTE: ER and PR negative or estrogen poor is defined as any one of the following:\r\n** Local pathology report classifies them as negative\r\n** Allred score of 2 or below for ER and PR\r\n** < 5% weakly positive staining for ER and PR\r\n* NOTE: HER2- is defined as follows: \r\n** HER2 will be considered negative if scored 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of < 2.0 or < 6 copies per cellXx_NEWLINE_xXHas documented HER2 negative expression according to American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelinesXx_NEWLINE_xXHas documented hormone (estrogen and/or progesterone) receptor (HR)-positive diseaseXx_NEWLINE_xXER+ve tumours defined as ?1% of tumour cells positive for ER on IHC staining or an IHC score (Allred) of ?3Xx_NEWLINE_xXER with <1% of cells positive on IHC or an IHC score (Allred) of ?2Xx_NEWLINE_xXHER2 with 0, 1+ or 2+ intensity on IHC and no evidence of amplification of the HER2 gene on ISHXx_NEWLINE_xXHER2 status negativeXx_NEWLINE_xXHER2 overexpression by immunohistocytochemistry (IHC) of 2+ or 3+, in the primary tumor or metastasis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by fluorescence in situ hybridization (FISH)Xx_NEWLINE_xXSubjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samplesXx_NEWLINE_xXThe tumor specimen obtained at the time of diagnosis of locally recurrent or metastatic disease must have been demonstrated to be HER2-positive based on central testing; HER2-positive is defined as HER2/chromosome enumeration probe 17 (CEP17) ratio >= 2.0 or >= 6 average HER2 copy number per cell by in situ hybridization (ISH) or IHC 3+ by current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines; sites must send biopsy specimens for central testing which have been determined to be HER2-positive or HER2-equivocal on local testingXx_NEWLINE_xXThe tumor specimen obtained at the time of diagnosis used for HER2 testing must also have central testing for estrogen receptor (ER) and progesterone receptor (PgR) according to current ASCO/CAP guideline; patients with < 1% ER and PgR staining by IHC will be classified as negativeXx_NEWLINE_xXThe tumor specimen obtained at the time of diagnosis used for HER2 and ER/and PgR testing must also have central testing for PD-L1 status; patients who are negative or positive are eligibleXx_NEWLINE_xXConfirmed diagnosis of ER-positive, HER2-negative advanced breast cancer, not amenable to curative therapyXx_NEWLINE_xXA diagnosis of invasive breast cancer, with or without an in situ component, that is: \r\n* Originally identified by screening mammography \r\n* Characterized by standard diagnostic mammography +/- breast ultrasound\r\n* Clinically node negative \r\n* Confirmed by breast magnetic resonance imaging (MRI) in a facility that maintains active American College of Radiology (ACR) accreditation to be of low clinical stage (=< 2 cm, node negative, unifocal invasive)\r\n* Estrogen receptor (ER) and progesterone receptor (PR) Allred scored, each > 5/8\r\n* Her2 negative using American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines\r\n* ki?67 proliferation scored, < 20%\r\n* Clinical Nottingham grade 1 or 2\r\n* Scored on the MammaPrint 70-gene breast cancer recurrence assay as low riskXx_NEWLINE_xXPatients who will participate in the endocrine therapy cohort must have invasive breast cancer that is estrogen receptor (ER)+ (? 1% ER staining by immunohistochemistry [IHC])Xx_NEWLINE_xXHistologically or cytologically confirmed ER+ HER2- breast cancer; ER-positivity is to follow local guidelines; if immunohistochemistry (IHC) HER2 is 2+, a negative fluorescence in situ hybridization (FISH) test is requiredXx_NEWLINE_xXPatient has disease that is hormone-receptor positive (estrogen receptor [ER] and/or progesterone receptor [PR] positive [+], HER-2/neu negative [-]) or triple-negative (ER/PR/HER-2/neu -).Xx_NEWLINE_xXEstrogen receptor negative – defined as less than 1% staining by immunohistochemistry (IHC)Xx_NEWLINE_xXProgesterone receptor negative – defined as less than 1% staining by IHC\r\n* HER2 negative defined as 0 or 1+ using IHC or a ratio of less than 2.0 on fluorescence in situ hybridization (FISH) testing; HER2 of 2+ on IHC should have a ratio of less than 2.0 on FISH testing to be considered HER2 negativeXx_NEWLINE_xXDocumentation of HER2 negative breast cancer at the time of protocol registration; (Note: HER2 negativity is defined as 0 or 1+ by immunohistochemistry OR nonamplified or equivocal by fluorescence in situ hybridization [FISH]; status may be defined on the basis of historic results on the breast primary or a metastatic site, whichever is most recent; repeat biopsies are not required for participation in this protocol)Xx_NEWLINE_xXKnown hormone receptor status at the time of protocol registration; (Note: estrogen receptor [ER] and/or progesterone receptor [PgR] status are considered positive with a cut-off of >= 1% invasive tumor cells; status may be defined on the basis of historic results on the breast primary or a metastatic site, whichever is most recent; repeat biopsies are not required for participation in this protocol)Xx_NEWLINE_xXTNBC defined as ER and PR negative (<1%) and HER-2 negative (FISH negative or IHC 0-1+)Xx_NEWLINE_xXCompletely resected unilateral or bilateral primary carcinoma of the breast without clinical evidence of disease, negative for estrogen receptor (ER) and progesterone receptor (PR) (cut-off for positivity is > 1% positive tumor cells with nuclear staining), and negative for HER2 as defined by one of the four situations delineated below: \r\n* HER2 immunohistochemistry (IHC) expression of 0 or 1+ and in-situ hybridization non-amplified\r\n* HER2 IHC expression of 0 or 1+ and in-situ hybridization not done\r\n* HER2 IHC expression of 2+ and in-situ hybridization non-amplified\r\n* IHC not done and in-situ hybridization non-amplified\r\n* Note: central review is not requiredXx_NEWLINE_xXPatients must have known estrogen receptor (ER), progesterone receptor (PR), and HER2 status defined as triple-negative breast cancer (TNBC), defined as:\r\n* ER and PR =< 10% by immunohistochemistry, and HER2-negative (as per American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guidelines, defined as immunohistochemistry [IHC] 0 or 1+, or fluorescence in situ hybridization [FISH] ratio < 2.0 or HER2 copy number < 6.0)Xx_NEWLINE_xXHER2+ as 3+ by IHC or in-situ hybridation (ISH) amplified.Xx_NEWLINE_xXImmunohistochemical studies must demonstrate the invasive component of the tumor to be estrogen receptor positive (ER+) (>= 10%) or progesterone receptor positive (PR+), human epidermal growth factor receptor 2 negative (HER2-) and grade 1 or 2Xx_NEWLINE_xXNewly diagnosed histologically confirmed stage I-III, estrogen receptor (ER), progesterone receptor (PR) and HER2 negative invasive breast cancer as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard National Comprehensive Cancer Network (NCCN) practice guidelines (Theriault et al, 2013)Xx_NEWLINE_xXPathologically confirmed squamous cell carcinoma of the head and neck OR pathologically confirmed invasive breast adenocarcinoma with documented estrogen receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2 (HER2) status and radiographic evidence of distant metastatic diseaseXx_NEWLINE_xXHead and neck cancer OR metastatic breast for which standard therapy is not curative\r\n* NOTE: Patients with ER/PR positive, HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease and no longer be candidates for standard endocrine therapy; patients with HER2 positive breast cancer irrespective of ER/PR status must have received or no longer be candidates for standard HER2 directed therapy (i.e., trastuzumab, pertuzumab, trastuzumab emtansine, and lapatinib); patients with ER/PR/HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease; ER/PR and HER2 status are defined by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelinesXx_NEWLINE_xXClinical stage operable I, II or III invasive mammary carcinoma, which is estrogen receptor (ER)-positive by immunohistochemistry (IHC) and human epidermal growth factor receptor 2 (Her2)-negative by Hercep test (0 or 1+) or not overexpressed by fluorescent in situ hybridization (FISH)Xx_NEWLINE_xXEstrogen receptor (ER) and progesterone receptor (PR) negative; defined as ER =< 10% and PR =< 10% staining by immunohistochemistry (IHC)Xx_NEWLINE_xXHER2 negative in the primary or metastatic tumor tissue defined as:\r\n* Immunohistochemistry (IHC) grade 0 as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within =< 10% of the invasive tumor cell; OR\r\n* IHC 1+ as defined by incomplete membrane staining that is faint/barely perceptible and within > 10% of the invasive tumor cell; OR\r\n* IHC grade 2+ staining intensity by means of IHC analysis with no gene amplification below; OR\r\n* No gene amplification on in situ hybridization (ISH) based on:\r\n** Single-probe average HER2 copy number < 4.0 signals/cell OR\r\n** Dual-probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number < 4.0 signals/cellXx_NEWLINE_xXPSTAT3 SCREENING: Patients must have known estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) status defined as either:\r\n* Triple-negative breast cancer, defined as: ER and PR < 10% by immunohistochemistry, and HER2-negative (defined as IHC 0 or 1+, or fluorescent in situ hybridization [FISH] ratio < 2.0) (Note, in patients who have ER, PR, HER2 results available on both primary and metastatic biopsy, results of the metastatic biopsy should take precedence in defining tumor phenotype)\r\n* Or, inflammatory breast cancer with any ER, PR, HER2 statusXx_NEWLINE_xXPatients must have known ER, PR, and HER2 status defined as either:\r\n* Triple-negative breast cancer, defined as: ER and PR < 10% by immunohistochemistry, and HER2-negative (defined as IHC 0 or 1+, or FISH ratio < 2.0)\r\n* Or, inflammatory breast cancer with any ER, PR, HER2 statusXx_NEWLINE_xXThe subject must have histologically or cytologically confirmed metastatic estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+) and human epidermal growth factor receptor 2 (HER2) negative breast cancer; (stains may be performed on either primary or metastatic tumor samples, ER and PR assays will be considered positive if there are at least 1% positive tumor nuclei in the sample as per American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guidelines, HER2 negative as per ASCO/CAP guidelines)Xx_NEWLINE_xXTumors must be HER2 negative defined as HER2 0 or 1+ by immunohistochemistry (IHC) assays and/or lack of gene amplification by fluorescence in situ hybridization (FISH) defined as a ratio < 2 on invasive tumor by local reviewXx_NEWLINE_xXEstrogen receptor (ER) and progesterone receptor (PgR) status by IHC must be known; tumor must be ER and PR negative (=< 5% staining) by local reviewXx_NEWLINE_xXEstrogen receptor positive tumor and/or progesterone receptor positive tumorXx_NEWLINE_xXEstrogen receptor negative and progesterone receptor negative tumorXx_NEWLINE_xXHistologically and/or cytologically confirmed diagnosis of ER+ and/or progesterone receptor positive (PR+) breast cancer by local laboratoryXx_NEWLINE_xXHER2-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+; if IHC is 2+, a negative in situ hybridization (fluorescence in situ hybridization [FISH], chromogenic in situ hybridization [CISH], or silver in situ hybridization [SISH]) test is required by local laboratory testingXx_NEWLINE_xXHistologically confirmed TNBC, defined as negative immunohistochemical staining for estrogen and progesterone receptors (=< 5% of nuclei positive by immunohistochemistry [IHC]) and human epidermal growth factor receptor 2 (HER2) negative (IHC 0-1+ or HER2-neu negative according to American Society of Clinical Oncology and the College of American Pathologists [ASCO-CAP] guideline)Xx_NEWLINE_xXHistologically proven HER-2 negative breast cancer (HER-2 negative defined as HER immunohistochemistry [IHC] 0 or 1+ and/or HER-2 fluorescence in situ hybridization [FISH] negative); HER-2 negative breast cancer includes hormone positive (estrogen receptor [ER] and/or progesterone receptor [PR] positive) breast cancer and triple negative breast cancer (TNBC)Xx_NEWLINE_xXEstrogen (ER) and/or progesterone (PR)-positive at primary diagnosis and at metastatic diagnosis where tissue is available (defined as > or = 1% of staining nuclei)Xx_NEWLINE_xXHuman epidermal growth factor receptor 2 (HER2)/neu-negative breast cancer by standard criteria (immunohistochemistry [IHC] < 3+ or fluorescence in situ hybridization [FISH] negative if IHC 2+) at primary diagnosisXx_NEWLINE_xXHER2 positive disease as defined by 3+ IHC or positive FISH (both in primary and metastatic sites)Xx_NEWLINE_xXPatients with histologically confirmed, metastatic HER2+ (by immunohistochemistry [IHC] 3+ or fluorescence in situ hybridization [FISH] ratio >= 2.0) breast cancerXx_NEWLINE_xXThe tumor must have been determined to be HER2-postive as follows:\r\n* Immunohistochemistry (IHC) 3+ or\r\n* In situ hybridization (ISH)-positive (defined by ratio of HER2 to circulating endothelial progenitors [CEP]17 >= 2.0 or HER2 gene copy number >= 6 per nucleus)Xx_NEWLINE_xXThe tumor must have been determined to be estrogen receptor (ER) and/or progesterone (PgR) positive assessed by current American Society of Clinical Oncology (ASCO)/College of American Pathologist (CAP) guideline recommendations for hormone receptor testing; patients with >= 1% ER or PgR staining by IHC are considered positiveXx_NEWLINE_xXPatients with HER2+ (immunohistochemistry [IHC] 3+ or fluorescence in situ hybridization [FISH]+ R/G > 2.0 or silver-enhanced in situ hybridization [SISH]+ HER2/chromosome 17 centromere [CEP17] > 2.0) breast cancer with documented central nervous system (CNS) recurrence or progression (potential participants with newly diagnosed brain metastasis who have not received prior treatment for their lesions in the brain are eligible)Xx_NEWLINE_xXAny estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel aloneXx_NEWLINE_xXPatients have positive HER2 expression by immunohistochemistry (IHC) (3+) or fluorescence in situ hybridization (FISH) testing (> 2.0 ratio)Xx_NEWLINE_xXHER2/neu negative disease (performed on primary tumor and/or metastatic lesion using commercially available/approved assay in local institutional or reference laboratory), according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelinesXx_NEWLINE_xXNational Comprehensive Cancer Network (NCCN) guidelines recommend for metastatic breast cancer “…biopsy documentation of first recurrence, if possible, and determination of hormone receptor status (estrogen receptor [ER] and progesterone receptor [PR]) and HER2 status….”; therefore, histologic and/or cytologic confirmation of metastatic disease is encouraged whenever feasible, but not required; in some circumstances, histologic confirmation may not be feasible (eg, bone metastases not amenable to biopsy and elevated cancer antigen [CA]27-29 tumor marker); for patients who have had histologic confirmation of metastatic disease, it is required that the biopsy confirm that the metastatic tumor is ER and/or PR positive, and HER2/neu negative; for patients in whom biopsy confirmation of metastatic disease is not feasible, it is required that the primary tumor be ER and/or PR-positive and HER2/neu negativeXx_NEWLINE_xXHER2 positive breast cancer (immunohistochemistry [IHC] 3+ or fluorescent in situ hybridization [FISH] ratio of >= 2.0)Xx_NEWLINE_xXCONDITIONS FOR PATIENT ELIGIBILITY PRIOR TO STEP 2 REGISTRATION (HER2-POSITIVE PATIENTS ONLY)Xx_NEWLINE_xXHistologically confirmed diagnosis of recurrent or residual epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, OR histologically confirmed metastatic breast cancer, that is estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)/neu negative (as determined by local pathology laboratory)Xx_NEWLINE_xXDiagnosis of advanced stage or metastatic HER2-positive cancer (immunohistochemistry or reverse transcriptase-polymerase chain reaction [RT-PCR] is used to determine HER2 positivity)Xx_NEWLINE_xXDiagnosis of advanced stage or metastatic HER2-positive cancer with disease progressed after receiving at least one prior systemic therapy (immunohistochemistry or RT-PCR is used to determine HER2 positivity)Xx_NEWLINE_xXAvailable autologous transduced EBV-specific cytotoxic T lymphocytes with >= 15% expression of HER2 CAR determined by flow-cytometry and killing of HER2-positive targets >= 20% in cytotoxicity assayXx_NEWLINE_xXHave histologically confirmed invasive breast cancer that is estrogen receptor (ER) negative (=< 10%), progesterone receptor (PR) negative (=< 10%) and human epidermal growth factor receptor 2 (HER2) normal (=< 10% of cells) by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)Xx_NEWLINE_xXPatients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2 status; estrogen and progesterone receptor positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either estrogen receptor (ER) or progesterone receptor (PR) >= 1% positive nuclear staining; HER-2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using immunohistochemistry (IHC), in situ hybridization (ISH) or both; HER-2 is negative if a single test (or all tests) performed in a tumor specimen show: a) IHC negative (0 or 1+) or b) ISH negative using single probe or dual probe (average HER-2 copy number < 4.0 signals per cell by single probe or HER-2/CEP ration < 2.0 with an average copy number < 4.0 signals per cell by dual probe); if HER-2 IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+; HER-2 equivocal is not eligibleXx_NEWLINE_xXPatients must harbor a tumor HER2/neu+ based upon IHC staining score of “3+” or 2+ with confirmed gene amplification by FISH to be includedXx_NEWLINE_xXDocumented HER2 overexpression or gene-amplified tumor (immunohistochemistry [IHC] 3+ or IHC 2+ with confirmatory fluorescence in situ hybridization [FISH]+).Xx_NEWLINE_xXEstrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancerXx_NEWLINE_xXHistologically-confirmed metastatic adenocarcinoma of the breast with either invasive primary tumor or metastatic tissue confirmation of HER2+ status as defined by immunohistochemistry (IHC) with score of 3+, or, if 2+ with confirmatory fluorescence in situ hybridization (FISH) ratio of >= 2.0Xx_NEWLINE_xXEstrogen receptor (ER) and progesterone receptor (PgR) negative.Xx_NEWLINE_xXHuman epidermal growth factor receptor 2 (HER2) negative as per American Society of Clinical Oncology/College of American Pathologists guidelines.Xx_NEWLINE_xXPatients must have stage IV gastric or GEJ adenocarcinoma with HER2 overexpression and/or amplification as determined by next generation sequencing assay, (immunohistochemistry [IHC] 3+) or fluorescent in situ hybridization (FISH+ is defined as HER2:chromosome 17 centromere probe [CEP17] ratio >= 2.0); MSKCC confirmation of HER2 status is not mandatory prior to enrollment and treatment on study; for patients with outside HER2 testing, if sufficient tissue is available HER2 testing will be repeated at MSKCC for purpose of analysis and will not impact the patient's eligibilityXx_NEWLINE_xXPatients with advanced or metastatic breast cancer must have disease that is HER2-negative, estrogen receptor-negative, and progesterone receptor-negative (ie, TNBC). Patients with advanced or metastatic disease may have up to 4 lines of cytotoxic therapy. Neoadjuvant and adjuvant therapies are not counted towards lines of therapy.Xx_NEWLINE_xXPathologically confirmed HER2-positive MBCXx_NEWLINE_xXDocumented HER2+ breast cancer defined as: 3+ by immunohistochemistry (IHC) or with amplification by in situ hybridization with ratio >= 2.0; results from the local lab are acceptable; eligibility will not be affected by hormone receptor statusXx_NEWLINE_xXPatient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by local laboratory and has HER2 negative breast cancerXx_NEWLINE_xXSubjects must meet at least one of the following two criteria:\r\n* Histologically proven TNBC defined as estrogen receptor (ER) immunohistochemistry (IHC) =< 10%, progesterone receptor (PgR) IHC =< 10% and human epidermal growth factor receptor (HER)-2 negative disease per 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) HER testing guidelines (0 or 1+ by IHC; and/or HER2 ratio < 2.0 and HER2 copy number < 4 signals/cell by fluorescence in situ hybridization [FISH])\r\n* Confirmed germline BRCA1 or BRCA2 mutation associated breast cancer regardless of the subtype of breast cancerXx_NEWLINE_xXHER-2 positive by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) 2013 guidelines, confirmed by central testing confirmed by central testing (NeoGenomics Laboratories): \r\n* Immunohistochemistry (IHC) 3+ based on circumferential membrane staining that is complete, intense AND/OR\r\n* FISH positive based on one of the three following criteria:\r\n** Single-probe average HER2 copy number >= 6.0 signals/cell OR\r\n** Dual-probe HER2/chromosome 17 centromere (CEP17) ratio < 2.0 with an average HER2 copy number >= 6.0 signals/cell OR\r\n** Dual-probe HER2/CEP17 ratio >= 2.0\r\n* NOTE: HER-2 status must be confirmed to be positive by central review prior to patient starting protocol therapy; patients previously having had HER2 testing at NeoGenomics Laboratories, Inc. (formerly Clarient Laboratories) do not need to undergo retesting for central confirmation of HER2 status; ductal carcinoma in situ (DCIS) components should not be counted in the determination of HER2 statusXx_NEWLINE_xXEstrogen receptor (ER)/progesterone receptor (PR) determination is required; ER- and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocolXx_NEWLINE_xXPhase I (Cohorts J through S): Post-menopausal females with HER2-negative, hormone-receptor positive breast cancer that has progressed or failed to response to at least one prior endocrine therapy in the adjuvant or metastatic settingXx_NEWLINE_xXPhase II: Post-menopausal female participants with locally advanced or metastatic HER2-negative, hormone receptor-positive breast cancerXx_NEWLINE_xXEstrogen-receptor and progesterone-receptor expression both =< 1% by immunohistochemistry (IHC), and HER2-negative status as determined by the current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines; if a patient has more than one histological result, the most recent sample will be considered for inclusionXx_NEWLINE_xXhas HER2 positive expression confirmed per protocolXx_NEWLINE_xXCentrally confirmed hormone-receptor-positive (?1% ER and/or PR positive stained cells) and HER2-normal (IHC score 0-1 or FISH negative (in-situ hybridization (ISH) ratio) <2.0 status) assessed preferably on tissue from post-neoadjuvant residual invasive disease or core biopsy of the breast, or if no other tissue is available the residual tumor of the lymphnode can be assessed. In case of bilateral breast cancer hormonreceptor positivity and HER2-normal status has to be centrally confirmed for both sides.Xx_NEWLINE_xXHuman epidermal growth factor receptor 2 (HER2)-negative tumor by local laboratory testing (immunohistochemistry [IHC] 0, 1+ regardless of fluorescence in situ hybridization [FISH] ratio; IHC 2+ with FISH ratio lower than 2.0 or HER2 gene copy less than 6.0; FISH ratio of 0, indicating gene deletion, when positive and negative in situ hybridization [ISH] controls are present)Xx_NEWLINE_xXHER-2 positive BC as defined by an immunohistochemistry score of 3 or gene amplified by in-situ hybridization as defined by a ratio of greater than or equal to (>=) 2.0 for the number of HER2 gene copies to the number of chromosome 17 copiesXx_NEWLINE_xXTumors must stain positive for estrogen receptor (>= 10%) by immunohistochemistry (IHC)Xx_NEWLINE_xXPrimary tumor was negative for ER, PR (cut-off for positivity is >10% positive tumor cells with nuclear staining) and negative for Her2-neu (0 or 1+ on immunohistochemistry and/or normal gene copy number by in-situ hybridization); Central review is not required.Xx_NEWLINE_xXER-positive tumor, HER2-negative breast cancerXx_NEWLINE_xXWomen who agree to undergo a standard of care core biopsy of recurrent or metastatic breast cancer to confirm the ER+ (>= 10% nuclear staining) and HER2 negative statusXx_NEWLINE_xXHistologic confirmation, from the A011203 pre-registration biopsy, by institutional/local pathologist of either locally advanced or metastatic breast cancer that is estrogen receptor positive and HER2 negative; those patients with bone only disease with either no tumor or insufficient tumor for ER/progesterone receptor (PR) and HER2 staining after the bone biopsy are still eligible to participate in this studyXx_NEWLINE_xXEstrogen receptor positive disease is defined as > 10% nuclear stainingXx_NEWLINE_xXHER2 negative disease as per 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, one of the following must apply:\r\n* 0 or 1+ by immunohistochemistry (IHC) and not amplified by in situ hybridization (ISH)\r\n* 0 or 1+ by IHC and ISH not done\r\n* 2+ by IHC and not amplified by ISH or\r\n* IHC not done and not amplified by ISHXx_NEWLINE_xXDocumentation of histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative adenocarcinoma of the breast must be available.Xx_NEWLINE_xXConfirmed diagnosis of HR-negative, HER2-negative (locally recurrent or metastatic TNBC) breast cancerXx_NEWLINE_xXHER2-positive disease by local laboratory testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization positive)Xx_NEWLINE_xXEstrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.Xx_NEWLINE_xXHER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).Xx_NEWLINE_xXDocumented HER2-negative tumor based on local testing on most recent tumor biopsy (immunohistochemistry score 0/1+ or negative by in situ hybridization HER2/CP17 ratio < 2 or for single probe assessment HER2 copy number < 4)Xx_NEWLINE_xXEstrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) testing in progress (i.e. on outside or MSKCC biopsy report)\r\n* HER2-positive pathology is permittedXx_NEWLINE_xXPatients may have any molecular status (estrogen receptor [ER], progesterone receptor [PR] and human epidermal growth factor receptor 2 [HER2]) and must have failed at least 1 systemic regimen after their diagnosis of locoregional diseaseXx_NEWLINE_xXTriple-negative breast cancer (TNBC) defined as histologically confirmed diagnosis of breast cancer and must have received at least 1 chemotherapy-containing regimen for advanced disease (recurrent or metastatic). Tumour must be triple-negative, defined as minimal or no expression of estrogen and progesterone receptors [<10% of cells positive by immunohistochemistry (IHC)], and minimal or no expression of HER2 (IHC staining 0 or 1+ or FISH-).Xx_NEWLINE_xXHistological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) Breast Cancer by local laboratory testing, based on last available tumor tissue.Xx_NEWLINE_xXIf IHC HER2 2+, a negative FISH test is requiredXx_NEWLINE_xXPatient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer.Xx_NEWLINE_xXPre and postmenopausal women or men with stage IV estrogen receptor positive (ER+) breast cancer histological or cytological confirmation\r\n* ER-positive tumors\r\n** Progressed after at least one line of hormonal therapy\r\n** Any number of prior chemotherapy in the metastatic setting\r\n** Any number of prior hormonal therapies\r\n* ER-negative tumors\r\n** PD-L1 low, high or unknown\r\n** Progression after prior PD-1 or PD-L1 inhibitors allowed\r\n** HER2 positive or negativeXx_NEWLINE_xXPatients that are estrogen receptor positive (ER+) will take anti-estrogen therapy for treatment of their DCIS during vaccinationsXx_NEWLINE_xXConfirmed diagnosis of HER2 positive diseaseXx_NEWLINE_xXNegative human epidermal growth factor receptor 2 (HER-2)/neu- disease defined as patients with fluorescence in situ hybridization (FISH) ratio < 2.0 or < 6.0 HER2 gene copies per nucleus, and IHC staining scores of 0, 1+, or 2+Xx_NEWLINE_xXPatient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancerXx_NEWLINE_xXHave a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancerXx_NEWLINE_xXKnown Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (PR) positive breast cancerXx_NEWLINE_xXTumor must be human epidermal growth factor receptor 2 (HER-2-neu) negative (defined as 0 or 1+ staining by immunohistochemistry or gene amplification ratio =< 2.0, by fluorescent in situ hybridization [FISH]), estrogen and progesterone receptors negative (< 1%); patients with BRCA 1 or 2 mutations will NOT be includedXx_NEWLINE_xXHER2 negative breast cancer. Central testing (required for all subjects) must demonstrate that the tumor is HER2 negative by FISH or Immunohistochemistry (IHC).Xx_NEWLINE_xXER positive breast cancer. Central testing (required for all subjects) must demonstrate that the tumor is ER+ with low expression (H-score [1-159]).Xx_NEWLINE_xXInvasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions =< 2 cm) that are estrogen or progesterone receptor positive and do not exhibit human epidermal growth factor receptor 2 (HER2)/neu gene amplification OR ductal carcinoma in situ (lesions =< 2 cm)Xx_NEWLINE_xXPathologic (histologically or cytologically) documented extracranial diagnosis of primary lung cancer, melanoma, human epidermal growth factor receptor 2 (HER2)-amplified or immuno-positive breast cancer, or HER2-amplified or immuno-positive gastric cancer, with brain metastasis detected by contrast enhanced magnetic resonance imaging (MRI) or computed tomography (CT) is required; patients with concurrent leptomeningeal diseases are eligibleXx_NEWLINE_xXConfirmed diagnosis of HER2 positive diseaseXx_NEWLINE_xXAll positive or negative ER (estrogen receptor), PR (progesterone receptor), and HER-2 subjects are eligible for this study.Xx_NEWLINE_xXKnown hormone receptor status (estrogen receptor and progesterone receptor)Xx_NEWLINE_xXConfirmed HER2 positive statusXx_NEWLINE_xXDocumentation of amplified PDGFR by fluorescent in-situ hybridization (FISH), colorimetric in-situ hybridization (CISH), or quantitative polymerase chain reaction (PCR) from tumor tissue (>= 3 copy number), or over expression by immunohistochemistry (IHC)Xx_NEWLINE_xXMust have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, stage I-III at diagnosis (AJCC 6th edition) based on initial evaluation by clinical examination and/or breast imaging. NOTE: Patients with ER+ and/or PR+ may enroll ONLY if they are known carriers of a deleterious mutation in BRCA1 or BRCA2. Patients with HER2+ tumors may not enroll regardless of BRCA status.Xx_NEWLINE_xXHER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).Xx_NEWLINE_xXParticipants' primary and/or metastatic tumor is human epidermal growth factor receptor 2 (HER2)-negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC)Xx_NEWLINE_xXMolecular testing result from Clinical Laboratory Improvement Act (CLIA)-certified laboratory confirming that the tumor tissue has at least one of the following:\r\n* HER2 overexpression (3+ immunohistochemistry [IHC]); Note: HER2 2+ IHC is eligible if the tumor is amplified by fluorescence in situ hybridization (FISH)\r\n* HER2 amplification by in situ hybridization assay (FISH or chromogenic in situ hybridization [CISH] signal ratio >= 2.0 or gene copy number > 6)\r\n* HER2 amplification by CLIA-certified next generation sequencing (NGS) sequencing assayXx_NEWLINE_xXHistologically proven diagnosis of TNBC per current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline;\r\n* Estrogen receptor (ER) negative (ER expression =< 1% positive tumor nuclei), progesterone receptor (PR) negative (PR expression =< 1% positive tumor nuclei) and HER2 negative breast cancer by IHC and /or fluorescence in situ hybridization (FISH)Xx_NEWLINE_xXDocumentation of ER-positive and/or progesterone receptor (PR)-positive tumor.Xx_NEWLINE_xXInvasive breast cancer must be estrogen receptor-positive (ER+) in > 66 % of the cells or ER allred score 6-8; if ER is positive in >= 66%, the staining intensity (weak, intermediate, strong) is needed to calculate the allred score to determine eligibility; in institutions where ER expression is classified only by < 1%, 1-10%, and > 10% cut-offs, > 10% expression is required for inclusionXx_NEWLINE_xXInvasive breast cancer must be HER2 negative; HER2 negative is defined as a single test or both tests used to determine HER2 status (in situ hybridization [ISH] and immunohistochemistry [IHC]) show:\r\n* IHC 1+ as defined by incomplete membrane staining that is faint/barely perceptible and within > 10% of the invasive tumor cells\r\n* IHC 0 as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within =< 10% of the invasive tumor cells\r\n* ISH single-probe average HER2 copy number < 4.0 signals/cell\r\n* ISH dual-probe HER2/chromosome 17 centromere probe (CEP17) ratio < 2.0 with an average HER2 copy number < 4.0 signals/cellXx_NEWLINE_xXStage IV HER2/Neu positive breast cancer patients who failed previous anti-HER2 targeted therapiesXx_NEWLINE_xXHER2 positivity as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelinesXx_NEWLINE_xXIf HER2 negative by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH), but activating somatic mutations of HER2 gene identified through genomic sequencing including but not limited to the following (Clinical Laboratory Improvement Act [CLIA] certified lab test): missense substitutions (G309A, G309E, S310F, S310Y, S653C, V659E, R678Q, V697L, T733I, L755S, L755P, E757A, D769H, D769Y, D769N, G776V, G776C, V777L, L841V, V842I, R849W, L869R, R896C); insertions/deletions (A775_G776insYVMA aka Y772_A755dup, G776VinsC, G776AinsVGC, G776 insertions, G778_S779insCPG, P780_781insGSP aka G778_P780dup, L755_T759del) and/or HER3 activating mutations; there is no limitation on the number of prior lines of systemic therapy or HER2-targeted therapies (prior neratinib not allowed)Xx_NEWLINE_xXEstrogen receptor and/or progesterone receptor positive diseaseXx_NEWLINE_xXThere should be a minimum of 4 weeks from any prior investigational drug, chemotherapy, immunotherapy, with the exception of hormonal therapy for prostate and breast cancers, HER2-directed therapy for HER2+ breast or stomach cancer (3+ immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH]+), drugs targeting EGFR, ALK or ROS1 in EGFR, ALK, ROS1-mutated lung cancer, respectively, or standard maintenance therapies for any solid tumor under the condition that subjects are on these therapies for at least two months before start of trial treatmentXx_NEWLINE_xXPatients must have histologically-confirmed unresectable, locally advanced or metastatic breast cancer that meets one of the following:\r\n* Triple negative, defined as estrogen receptor (ER) negative, progesterone receptor (PR) negative, human epidermal growth factor receptor 2 (HER2) negative; HER2 negative defined as immunohistochemistry (IHC) 0 or 1+ or fluorescence in situ hybridization (FISH) negative\r\n* Her2- negative hormone-refractory breast cancer which denotes progression on one or more endocrine therapies (e.g., tamoxifen, aromatase inhibitors, fulvestrant) unless contraindicatedXx_NEWLINE_xXPatients with documented HER2-positive metastatic disease are not eligible, even if their primary breast cancer was HER2-negativeXx_NEWLINE_xXSubject must have histologically confirmed stage IV TNBC (estrogen receptor [ER]-, progesterone receptor [PR]-, HER2-negative) and have received at least 1 prior line of systemic therapy\r\n* ER- and PR-negative: defined as < 1% staining by immunohistochemistry (IHC)\r\n* HER2-negative disease, defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio < 2.0Xx_NEWLINE_xXHistologically or cytologically-confirmed triple-negative breast cancer (TNBC) (defined as estrogen receptor [ER] < 1%, progesterone receptor [PR] < 1%, human epidermal growth factor receptor 2 [her-2]-neu 0-1+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH]-negative or as per doctor of medicine [MD] discretion) at each enrolling institutionXx_NEWLINE_xXHER2-positive diseaseXx_NEWLINE_xXHistologically or cytologically confirmed invasive breast cancer that is HER2-positive (3+ by immunohistochemistry [IHC] and/or > 2.0 by fluorescence in situ hybridization [FISH]) if concurrent HER2-directed therapy is plannedXx_NEWLINE_xXEstrogen receptor (ER)+ (ER- DCIS meeting other eligibility criteria are eligible)Xx_NEWLINE_xXEstrogen and/or progesterone receptor positive breast cancer (> 10% staining), as determined by pathology from either primary or metastatic site(s); central confirmation is not requiredXx_NEWLINE_xXHER2 negative, defined as 0-1+ by immunohistochemistry or fluorescence in situ hybridization (FISH)-negative (HER2 copy number < 6 and HER2/chromosome enumeration probe [CEP]17 ratio < 2.0); central confirmation is not requiredXx_NEWLINE_xXConfirmed HER2-positive disease by local pathology, defined as immunohistochemistry (IHC) 3+ or amplification by fluorescent in situ hybridization (FISH) (HER2/chromosome 17 centromere [CEP17] ratio >= 2 or an average of >= 6 HER2 gene copies per nucleus) AND confirmed by Central Pathology Review (Mayo Clinic Rochester) prior to patient being registered to begin protocol therapy\r\n* NOTE: ductal carcinoma in situ (DCIS) components should not be counted in the determination of HER2 statusXx_NEWLINE_xXFor patients with bilateral or multifocal/multicentric breast cancers, one of the following criteria must be met to enroll: (1) each cancer individually meets criteria for enrollment (only ONE tumor has to undergo central confirmation for HER2), OR (2) at least one tumor meets eligibility (per tumor size/nodes/subtype outlined above) and the other foci in the ipsilateral or contralateral breast are also HER2-positive but are too small for enrollment (e.g., a patient is eligible if a cancer is T2N0 and HER2-positive in one breast, but the contralateral breast has a T1b HER2+ cancer that isn’t eligible on its own, OR, (3) at least one tumor meets eligibility and the other foci in the ipsilateral or contralateral breast are HER2-negative and do not meet criteria for adjuvant chemotherapy per provider discretion (e.g. if a patient has a HER2-positive tumor meeting eligibility but also has a second, HER2-negative, small, node-negative, ER+, low grade cancer present, she is still eligible for enrollment); however, in the specific case that a second breast cancer is stage III and HER2-negative, that patient is excluded (because the second cancer is high-risk and likely will require non-HER2-directed therapy)Xx_NEWLINE_xXHER2 PositiveXx_NEWLINE_xXSubject has human epidermal growth factor receptor 2 negative (HER2-) breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.Xx_NEWLINE_xXBreast tumors with hormone receptor positive disease (estrogen receptor [ER]+/progesterone receptor [PR]+, ER+/PR- regardless of HER2 status)Xx_NEWLINE_xXMen and women with advanced malignancies for which no standard therapy is available\r\n* Dose escalation: Patients with any solid tumor malignancies \r\n* Dose expansion: \r\n** Patients with advanced malignancies that have germline and/or somatic BRCA mutations (cohort gBRCA) or\r\n** Triple negative (TN) metastatic breast cancer without known BRCA mutation (cohort TNBC); tumors will be considered TN when:\r\n*** Estrogen receptor (ER) expression < 1%\r\n*** Progesterone receptor (PR) expression < 1%\r\n*** Human epidermal growth factor receptor 2 (Her2) negative as per the American Society of Clinical Oncology (ASCO) guidelines\r\n** Paclitaxel expansion: any solid tumor malignancy with potential benefit from this combination and paclitaxel (ASP)Xx_NEWLINE_xXOperable ER-positive/HER2- negative, invasive early breast cancer, suitable for neoadjuvant AI treatment. HER2-negative as determined by American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelines.Xx_NEWLINE_xXHER2-positive as determined using ASCO-CAP Guidelines.Xx_NEWLINE_xXHistologically documented HER2 (+) breast cancer as defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) amplification of >= 2.0 of primary or metastatic site; results from the local lab are acceptableXx_NEWLINE_xXPatients must have a histologically confirmed diagnosis of hormone receptor positive, HER2 negative invasive breast carcinomaXx_NEWLINE_xXTumors must be estrogen and/or progesterone receptor positive according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2010 guidelines as either estrogen receptor (ER) or progesterone receptor (PR) >= 1% positive nuclear staining by immunohistochemistry; estrogen and/or progesterone receptor results by Oncotype Dx will not be acceptedXx_NEWLINE_xXTumors must be HER2 negative as defined according to ASCO/CAP 2013, as HER2 0-1+ by immunohistochemistry (IHC) or non-amplified fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH); if HER2 IHC is 2+, FISH/CISH must be performed and must not be positive (must be a ratio of < 2), but otherwise FISH/CISH is not required if IHC is 0 or 1+ by institutional standardsXx_NEWLINE_xXIn patients with multicentric or bilateral invasive breast cancers, all sampled lesions must be hormone receptor-positive and HER2-negative and have an Oncotype Dx recurrence score =< 25; one lesion (typically the largest) should be designated as the target lesion for which response to the neoadjuvant therapy will be judgedXx_NEWLINE_xXDocumentation of HER2 overexpression or gene amplification, in the invasive component of either the primary tumor or metastatic disease site as defined as: 3+ by Immunohistochemistry (IHC) and/orXx_NEWLINE_xXHER2/neu gene amplification by fluorescence, chromogenic, or silver in situ hybridization [FISH, CISH or SISH;>=6 HER2/neu gene copies per nucleus or a FISH, CISH, or SISH test ratio (HER2 gene copies to chromosome 17 signals) of >=2.0 OR HER2/chromosome 17 ratio <=2.0 with average HER2 copy number >=6 signals/cell nucleus]Xx_NEWLINE_xXCentrally determined HER2-positive, hormone receptor status, breast molecular subtype by Prediction Analysis of Microarray 50 (PAM50) on the pre-treatment biopsy of metastatic lesion obtained during screeningXx_NEWLINE_xXHER2-positive breast cancer confirmed by a central laboratoryXx_NEWLINE_xXHistologically confirmed invasive breast carcinoma, stage I-III\r\n* Note: estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) status must be known; in newly diagnosed patients planning neoadjuvant treatment, a formal assessment of axillary lymph nodes is not requiredXx_NEWLINE_xXPostmenopausal, Hormone receptor positive (HR+), HER2 negative breast cancerXx_NEWLINE_xXPatients with both ER positive and ER negative breast cancer are eligible for this study; patients with human epidermal growth factor receptor 2 (HER2) positive disease will be excluded from participation in this studyXx_NEWLINE_xXPHASE II: Patients must have known estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) status defined as triple-negative breast cancer (TNBC), defined as:\r\n* ER and PR =< 10% by immunohistochemistry, and HER2-negative (defined as immunohistochemistry [IHC] 0 or 1+, or fluorescent in situ hybridization [FISH] ratio < 2.0)Xx_NEWLINE_xXPatients must have histologically-confirmed HER2-positive breast cancer that is locally advanced or metastatic; HER2-positive disease must be documented by one of the following results using Food and Drug Administration (FDA)-approved testing methods: \r\n* Fluorescence in situ hybridization (FISH)-positive (with an amplification ratio >= 2.0 indicating positive status) and/or \r\n* Immunohistochemistry (IHC) 3 + by local laboratory assessmentXx_NEWLINE_xXPatients with HER2 positive disease.Xx_NEWLINE_xXHER2 positive breast cancer (3+ by immunohistochemistry or Her2 gene amplification by in situ hybridization with a ratio of HER2 gene signals to centromere 17 signals > 2.0 or average HER2 copy number > 6.0 signals/cell)Xx_NEWLINE_xXHuman growth factor receptor 2 (HER2) positive tumors as defined by Food and Drug Administration (FDA) guidelines (3+ immunohistochemical staining, defined as uniform, intense membrane staining of more than 10% of invasive tumor cells, and for cases with 2+ staining showing gene amplification by fluorescence in situ hybridization [FISH], expressed as a ratio of more than 2 when comparing HER-2 gene and chromosome 17 fluorescent signals)Xx_NEWLINE_xXHER2+ metastatic breast cancer, documented as HER2+ by FISH and/or 3+ staining by immunohistochemistry.Xx_NEWLINE_xXPathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): eligible participants must have either: Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratoryXx_NEWLINE_xXPatients must have histologically or cytologically confirmed metastatic invasive breast cancer that is negative for the estrogen receptor (ER), progesterone receptor (PR) and HER2 by institutional guidelinesXx_NEWLINE_xXPatient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.Xx_NEWLINE_xXPatient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.Xx_NEWLINE_xXMust have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage I-III at diagnosis (AJCC 6th edition) based on initial evaluation by physical examination and/or breast imaging prior to study registration. NOTE: ER, PR and HER2 status will be confirmed by central pathology review prior to randomization. ER and PR will be considered negative if ? 1% of cells stain weakly positive. HER2 will be considered negative if scored 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of < 2.0 or < 6 copies per cell.Xx_NEWLINE_xXPatient must have histologically confirmed (by routine hematoxylin and eosin [H&E] staining) estrogen receptor (ER)-negative invasive adenocarcinoma of the breastXx_NEWLINE_xXHER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or fluorescence in situ hybridization (FISH) (>= 2.0)Xx_NEWLINE_xXNon-metastatic, histologically or cytologically-confirmed triple negative breast cancer (TNBC) (defined as estrogen receptor [ER] <1%, progesterone receptor [PR] <1%, her-2-neu 0-1+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH]-negative or as per doctor of medicine [MD] discretion).Xx_NEWLINE_xXDocumented HER2 overexpression (immunohistochemistry [IHC] 3+ or gene-amplified tumor with fluorescence in situ hybridization [FISH] ratio of >= 2.0)Xx_NEWLINE_xXParticipants must have histologically or cytologically confirmed inoperable locally advanced or metastatic ER+ breast cancer; to fulfill the requirement for ER+ disease, a breast cancer must express, by immunohistochemistry (IHC), ER in >= 10% of cells, on the most recent biopsy; central confirmation of ER status is not requiredXx_NEWLINE_xXParticipants must have documented HER2+ disease by overexpression and/or gene amplification on the most recent biopsy, per current ASCO-CAP (American Society of Clinical Oncology – College of American Pathologists) 2013 guidelines; central confirmation of HER2 status is not requiredXx_NEWLINE_xXPatients have positive estrogen receptor (ER) expression in the primary tumor site by immunohistochemistry (IHC) (defined as >= 10%) (progesterone receptor [PR] status is not required)Xx_NEWLINE_xXPatients have HER2-positive breast carcinoma (IHC staining more than 3+ or HER2 gene amplification by fluorescent in situ hybridization [FISH])Xx_NEWLINE_xXHER2 overexpression by immunohistochemistry (IHC) of 2+ or 3+ in the primary tumor or metastasis; or documented gene amplification by fluorescent in situ hybridization (FISH) analysis; IHC =< 2+ must have HER2 gene amplification documented by FISHXx_NEWLINE_xXParticipants must have histologically confirmed HER2+ (3+ by immunohistochemistry and/or FISH ratio >= 2.0) invasive breast cancer; central confirmation of HER2 status is not requiredXx_NEWLINE_xXParticipants must have invasive primary tumor or metastatic tissue confirmation of HER2-positive status, defined as presence of one or more of the following criteria: HER2-positive by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) 2013 guidelines\r\n* Immunohistochemistry (IHC) 3+ based on circumferential membrane staining that is complete, intense OR\r\n* Fluorescent in situ hybridization (FISH) positive based on one of the three following criteria:\r\n** Single-probe average HER2 copy number >= 6.0 signals/cell; OR\r\n** Dual-probe HER2/chromosome 17 centromere (CEP17) ratio < 2.0 with an average HER2 copy number >= 6.0 signals/cell; OR\r\n** Dual-probe HER2/CEP17 ratio >= 2.0\r\n* Note: participants with a negative or equivocal overall result (FISH ratio of < 2.0 or =< 6.0 HER2 gene copies per nucleus) and IHC staining scores of 0, 1+, 2+ are not eligible for enrollmentXx_NEWLINE_xXHistologically documented HR+ breast cancer in either the primary or metastatic setting, as defined by estrogen receptor (ER) + or progesterone receptor (PR) +; results from the local lab are acceptable; eligibility will not be affected by human epidermal growth factor 2 (HER2) statusXx_NEWLINE_xXPatients with histologically confirmed stage I-III, HER2-positive invasive breast cancer for which adjuvant/neoadjuvant chemotherapy is indicated based on physician judgment following National Comprehensive Cancer Network (NCCN) practice guidelines\r\n* HER2 overexpression or amplification will be based on local test results and is defined as either:\r\n** Immunohistochemistry (IHC) staining of 3+ (uniform, intense membrane staining) in >= 10% of invasive tumor cells or\r\n** Fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus or\r\n** FISH ratio (HER2 gene signals to chromosome 17 signals) of >= 2.0Xx_NEWLINE_xXPatients with synchronous bilateral breast cancers are eligible if at least one of the tumors is HER2-positiveXx_NEWLINE_xXER/progesterone receptor (PR) determination is required; ER- and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocolXx_NEWLINE_xXHER-2 positive by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) 2013 guidelines, confirmed by central testing (Clarient laboratories [labs]):\r\n* IHC 3+ based on circumferential membrane staining that is complete, intense OR\r\n* Fluorescence in situ hybridization (FISH) positive based on one of the three following criteria:\r\n** Single-probe average HER2 copy number >= 6.0 signals/cell; OR\r\n** Dual-probe HER2/chromosome 17 centromere (CEP17) ratio < 2.0 with an average HER2 copy number >= 6.0 signals/cell; OR\r\n** Dual-probe HER2/CEP17 ratio >= 2.0\r\n* NOTE: ductal carcinoma in situ (DCIS) components should not be counted in the determination of HER2 status\r\n* NOTE: HER-2 status must be confirmed to be positive by central review prior to patient starting protocol therapy; patients previously having had HER2 testing at Clarient Laboratories do not need to undergo retesting for central confirmation of HER2 status; a pathology report documenting testing at Clarient should be provided at time of patient registrationXx_NEWLINE_xXPatients with hormone receptor +/- and HER2 +/- breast cancer are eligibleXx_NEWLINE_xXHER2 negative (IHC 0,1 or FISH HER2:CEP17 ratio < 2.0)Xx_NEWLINE_xXPatients may have hormone receptor positive or hormone receptor negative HER2-negative disease; hormone receptor positivity (estrogen receptor [ER] and/or progesterone receptor [PR]) is defined by at least 1% of positive tumor cells in the sample by immunohistochemistry (IHC); “triple negative” is defined by the lack of estrogen and progesterone receptor and by HER2-negative status; HER2-negative disease can be determined by fluorescent in situ hybridization (FISH) or IHC; negativity by IHC is defined as scores of 0 or 1+; borderline IHC results (i.e., 2+) should undergo FISH testing; subjects with an HER2 FISH ratio =< 2.0 are eligibleXx_NEWLINE_xXHistologically confirmed adenocarcinoma of the breast with the following markers: estrogen receptor negative (< 1%), progesterone receptor negative (< 1%), and human epidermal growth factor receptor (Her)-2/neu negative (Her-2/neu 0-1+ immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] ratio < 1.8 or average HER2 gene copy number of < four signal/nucleus for test systems without internal control probe) or breast adenocarcinoma identified as basal-like subtype on molecular testingXx_NEWLINE_xXHER2-positive breast cancer, defined as by American Society of Clinical Oncology College of American Pathologists (ASCO CAP) 2013 guidelines\r\n* Immunohistochemistry (IHC) 3+ based on circumferential membrane staining that is complete, intense AND/OR\r\n* Fluorescence in situ hybridization (FISH) positive based on one of the following three criteria: \r\n** Single-probe average HER2 copy number >= 6.0 signals/cell OR\r\n** Dual-probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number >= 6.0signals/cell; OR \r\n** Dual-probe HER2/CEP17 ratio >= 2.0Xx_NEWLINE_xXHistologically or cytologically confirmed estrogen/progesterone receptors (ER/PR) +/-; human epidermal growth factor receptor 2 (HER2)-, metastatic breast cancer.Xx_NEWLINE_xXClinical stage IV invasive mammary carcinoma, estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive by immunohistochemistry (IHC); patients with HER2 fluorescence in-situ hybridization (FISH) ratio < 2 (IHC 3+ is acceptable) will be enrolled in the ER+ / HER2-non-amplified cohort of patients; patients with HER2 FISH ratio >= 2 will be enrolled in the ER+ / HER2-amplified cohort of patients; patients may have either measurable or non-measurable disease, both are allowedXx_NEWLINE_xXPatients with ER and/or PR-positive/ HER2-amplified invasive mammary carcinoma must have had at least one line of HER2-targeted therapy in the metastatic setting, or be diagnosed with metastatic breast cancer during or within 1 year of adjuvant HER2-targeted therapy; there is no limit on lines of prior HER2-targeted treatments in the metastatic settingXx_NEWLINE_xXPRE-REGISTRATION INCLUSION CRITERIA: Histologically confirmed HER2-negative primary invasive ductal or invasive lobular breast carcinoma; for patients enrolling for neoadjuvant treatment, diagnosis must be clinical stage II or III; for patients enrolling for adjuvant treatment, diagnosis must be pathologic stage IIA to IIIC\r\n* Standard HER2 testing will be performed in the surgical specimen at Washington University according to the standard of care in the department of pathology; a HER2-negative primary breast cancer sample from a patient eligible for randomization should have a HER2 immunohistochemistry (IHC) score of 0 or 1+; those patients with IHC score of 2+ should be HER2 fluorescent in situ hybridization (FISH)-negative in standard testing\r\n* Patient will have undergone staging studies including a computed tomography (CT) of the chest/abdomen/pelvis and bone scan and/or positron emission tomography (PET) scan either prior to the initiation of treatment or prior to entry into the trial\r\n* In addition, patients with non-metastatic, HER2-negative, recurrent tumors who need chemotherapy are eligibleXx_NEWLINE_xXKnown hormone-receptor statusXx_NEWLINE_xXHistological or cytological confirmation of estrogen-receptor positive (ER+) human epidermal growth factor receptor 2 negative (HER2-) breast cancerXx_NEWLINE_xXConfirmed pathologic diagnosis of triple negative breast cancer (TNBC), OR estrogen receptor (ER) positive with immunohistochemistry (IHC) staining of 1-9%, irrespective of progesterone receptor (PR) staining, and human epidermal growth factor receptor (HER)2 negative, OR prior diagnosis of ER positive (>= 10%) (HER2 negative) breast cancer that is demonstrated to be ER < 10% on the patient’s most recent biopsy\r\n* NOTE: patients with a diagnosis of TNBC who are found to have ER or PR positive staining on any additional biopsies since diagnosis remain eligibleXx_NEWLINE_xXPatients enrolling on the phase II portion of this trial must have estrogen receptor (ER), progesterone receptor (PR) and HER2 negative disease defined as less than 10% staining for ER and PR, and HER2 0-1+ by immunohistochemistry (IHC), or 2+ by IHC and no evidence of amplification by fluorescence in situ hybridization (FISH) using local laboratory testingXx_NEWLINE_xXEstrogen and/or progesterone receptor positive breast cancer, as determined by pathology from either primary or metastatic site(s); central confirmation is not requiredXx_NEWLINE_xXHER2 negative, defined as 0-1+ by immunohistochemistry or FISH-negative (ratio < 2.2); central confirmation is not requiredXx_NEWLINE_xXOne of the following subgroups of patients with HER2 overexpression as follows: \r\n* Histologically-confirmed breast cancer that is metastatic or locally recurrent (7th Edition of the American Joint Committee on Cancer [AJCC] Tumor, Lymph Node, Metastasis [TNM] System) and measurable and/or evaluable or non-measurable by RECIST 1.1 criteria with HER2/neu overexpression by immunohistochemistry (2+,3+) or fluorescent in situ hybridization (FISH)+ and progressive disease despite having received at least 1 prior Food and Drug Administration (FDA) approved HER2 targeted therapy (e.g. trastuzumab, trastuzumab plus pertuzumab, T-DM1, or lapatinib) (determined by their physician); prior therapy has at least one of the following stipulations: \r\n** Patients may have received neoadjuvant or adjuvant treatment with prior trastuzumab or lapatinib treatment \r\n** Patients have received a trastuzumab, trastuzumab + pertuzumab, or T-DM1-based therapy for locally advanced or metastatic disease for a minimum of 9 weeks duration; patients may have received more than 1 trastuzumab-based combination therapy\r\n** Patients have received a lapatinib-based therapy for locally advanced or metastatic disease for a minimum of 9 weeks duration; patients may have received more than 1 lapatinib-based combination therapy\r\n* Histologically-confirmed gastric, esophageal, or gastroesophageal adenocarcinoma that is metastatic or locally recurrent (7th Edition of the AJCC TNM System) and measurable or non-measurable by RECIST 1.1 criteria with HER2/neu overexpression by immunohistochemistry (2+,3+) or FISH+ and progressive disease despite having received at least 1 prior HER2 targeted therapy for a minimum of 9 weeks duration) (determined by their physician) or with previously documented HER2 over-expressing disease not being currently treated on a HER2 targeted therapy\r\n* Other histologically confirmed metastatic (stage IV) or locally recurrent (stage III) (7th Edition of the AJCC TNM System) malignancy with HER2/neu overexpression by immunohistochemistry (2+,3+) or FISH+; no prior HER2 directed therapy will be required for this subgroup; however, patients will been required to have at least 1 line of therapy with a known survival benefit for their malignancyXx_NEWLINE_xXIf Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.Xx_NEWLINE_xXInvasive primary tumor or metastatic tissue confirmation of HER2-positive status, defined as presence of one or more of the following criteriaXx_NEWLINE_xXOver-expression by immunohistochemistry (IHC) with score of 3+ (in > 30% of invasive tumor cells) AND/OR HER2 gene amplification (average of > 6 HER2 gene copies per nucleus or a FISH ratio [HER2 gene copies to chromosome 17 signals] of >= 2.0), according to guidelines and in keeping with past eligibility for ratio of >= 2.0 rather than the ratio of > 2.2 required by new guidelinesXx_NEWLINE_xXNote: patients with a negative or equivocal overall result (FISH ratio of < 2.0 or =< 6.0 HER2 gene copies per nucleus) and IHC staining scores of 0, 1+, 2+ are not eligible for enrollmentXx_NEWLINE_xXHER2-positive as assessed by local laboratory on primary or metastatic tumorXx_NEWLINE_xXHormone-receptor positive defined as estrogen receptor-positive and/or progesterone receptor-positiveXx_NEWLINE_xXHistologically or cytologically confirmed estrogen receptor (ER) and/or progesterone receptor (PgR) positive carcinoma of the breast with unresectable, locally advanced and/or metastatic (American Joint Committee on Cancer [AJCC] Stage IV) diseaseXx_NEWLINE_xXTumors must be negative for HER2 (by FISH, CISH or IHC)Xx_NEWLINE_xXAt the recommended phase II dose level, a total of 20 patients with triple-negative breast cancer defined as estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative, will be enrolled and another 10 patients with a solid malignancy who would benefit from a paclitaxel and carboplatin-based regimen, will also be enrolledXx_NEWLINE_xXHer-2 normal as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemistry (IHC) staining.Xx_NEWLINE_xXPatient must have histologically or cytologically-confirmed metastatic breast cancer; any estrogen receptor (ER), progesterone receptor (PR) or human epidermal growth factor receptor 2 (Her2) status is allowedXx_NEWLINE_xXConfirmed pathologic diagnosis of breast cancer which is metastatic and for which capecitabine is a reasonable treatment option\r\n*ARMS C & D: Histologically confirmed human epidermal growth factor receptor 2 (HER2) positive (+) breast cancer: immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) amplified; by clinical assay on either primary or metastatic tumorXx_NEWLINE_xXPatients with the following types of histologically documented solid tumors:\r\n* Estrogen receptor (ER) positive (+)/progesterone receptor (PR)+, ER+/PR negative (-), or ER-/PR+ breast cancer\r\n* Gynecologic tumors (endometrial, ovarian, uterine, fallopian tube, peritoneal, etc.)\r\n* Desmoid tumors\r\n* Tumors that are ER+ or PR+ by immunohistochemistry (including low-level expression) such as non-small cell lung, colorectal, and prostateXx_NEWLINE_xXPatients must have tumors that demonstrate ER/PR+ (positivity by immunohistochemistry [IHC] staining >= 1%)Xx_NEWLINE_xXMust have estrogen and/or progesterone receptor positive histologically confirmed adenocarcinoma of the breast; receptor status may be based on any time during treatment prior to study registration, and from any site (i.e. primary recurrent, or metastatic)Xx_NEWLINE_xXParticipants must have histologically confirmed hormone receptor positive (HR+) HER2 negative metastatic or locally recurrent unresectable invasive breast cancer; both measurable and non-measurable disease are allowed; ER, progesterone receptor (PR) and HER2 measurements should be performed according to institutional guidelines, in a Clinical Laboratory Improvement Act (CLIA)-approved setting; cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelinesXx_NEWLINE_xXFor invasive cancers, the tumor must be estrogen receptor positive (defined as 10% or greater expression of estrogen receptor)Xx_NEWLINE_xXSubjects must have a histologically confirmed diagnosis of hormone receptor (HR)+/HER2+ positive locally advanced unresectable or metastatic breast cancer; estrogen or progesterone receptor positivity is defined by immunohistochemistry (IHC) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2010; HER2 positivity is defined by standard of care fluorescence in situ hybridization (FISH) and/or 3+ staining by IHC according to ASCO/CAP guidelines 2014Xx_NEWLINE_xXFor TNBC Subjects: Have histologically or cytologically confirmed diagnosis of metastatic (Stage IV) TNBC, and irrespective of PD-L1 status. TNBC is defined as negative immunohistochemistry (IHC) assays for Estrogen Receptor (ER), and Progesterone Receptor (PR), and HER2 negative (IHC 0 or 1+, or 2+ by IHC confirmed negative by FISH)Xx_NEWLINE_xXPatients must have esophageal, gastric or gastroesophageal adenocarcinoma with HER2 overexpression and/or amplification as determined by next generation sequencing assay, immunohistochemistry (IHC 3+) or fluorescent in situ hybridization (FISH+ is defined as HER2:CEP17 ratio >= 2.0); MSKCC or enrolling institution confirmation of HER2 status is not mandatory prior to enrollment and treatment on study; for patients with outside HER2 testing, if sufficient tissue is available HER2 testing will be repeated at MSKCC or the enrolling institution for purpose of analysis and will not impact the patient's eligibilityXx_NEWLINE_xXHistopathological diagnosis of triple negative breast cancer (ductal, lobular, mixed or metaplastic), defined as estrogen receptor (ER) < 1%, progesterone receptor (PR) < 1%, and human epidermal growth factor receptor 2 (HER2) negative according to American Society of Clinical Oncology/College of American Pathologists guidelines by local testing according to institutional standards; for tumors with equivocal interpretation of receptor status (e.g. “weak” or “faint” staining), the principal investigator will have final determination of triple negative statusXx_NEWLINE_xXHER2-positive breast carcinoma (IHC staining more than 3+ or HER2 gene amplification by fluorescent in situ hybridization [FISH])Xx_NEWLINE_xXInvasive carcinoma should be ER alpha receptor positiveXx_NEWLINE_xXPatients must have HER2-positive (fluorescence in situ hybridization [FISH]+ or immunohistochemistry [ICH] 3+) metastatic or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma to be eligible for trastuzumab; for the purposes of this protocol, FISH+ is defined as HER2:centromeric probe for chromosome 17 (CEP17) ratio >= 2.0; biopsy samples with cohesive IHC3+ or FISH+ clones are considered HER2 positive irrespective of size, i.e. < 10%; FISH+ defined as > 2 HER2:CEP17; Note: samples will be processed locally in the laboratory of investigational sites; the results of local laboratory HER2 analysis will be required and sufficient to start the study treatment; the Memorial Sloan-Kettering (MSK) laboratory will be used for subsequent confirmation of HER2 status; MSK pathology review will not be required to begin therapy on the protocol; samples provided to the MSK laboratory must either be HER2 IHC slides, or if FISH confirmation is necessary, a paraffin block(s) of adequate size to allow if possible for at least 5 slides with cuts that are 5-microns thick or if a paraffin block is not available, then if possible at least 5 slides with cuts that are 5-microns thick will be acceptable; archived or fresh tumor samples may be usedXx_NEWLINE_xXFor patients who are Her2 positive and will be treated on the trastuzumab + mDCF cohort, left ventricular function < 50%Xx_NEWLINE_xXOver-expression of HER2Xx_NEWLINE_xXTNBC confirmed by medical history as: human epidermal growth factor receptor 2 [HER2]-negative (confirmed by IHC 0, 1+ regardless of fluorescence in situ hybridization [FISH] ratio; IHC 2+ with FISH ratio lower than 2.0 or HER2 gene copy less than 6.0; FISH ratio of 0, indicating gene deletion, when positive and negative in situ hybridization [ISH] controls are present); estrogen receptor (ER) negative (confirmed as ER expression less than or equal to 1% positive tumor nuclei); progesterone receptor negative (confirmed as progesterone receptor expression less than or equal to 1% positive tumor nuclei)Xx_NEWLINE_xXPatients must have HER2-positive breast cancer as defined by ASCO/CAP 2013 guidelines that is confirmed by a Sponsor-designated central laboratoryXx_NEWLINE_xXDocumented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor [ER] and progesterone receptor [PR]) status and HER-2 statusXx_NEWLINE_xXPatients meeting the above pathologic criteria will be eligible for therapy irrespective of their HER2/neu over expression status; immunohistochemical staining will be not be required for protocol entry but fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) studies for HER2/neu are preferredXx_NEWLINE_xXHave negative HER2 expression by immunohistochemistry (IHC) (defined as 0 or 1+), or fluorescence in situ hybridization (FISH); if HER2 is 2+, negative HER2 expression must be confirmed by FISHXx_NEWLINE_xXTumor must be HER2 positive 3+ by immunohistochemistry or positive by fluorescence in situ hybridization (FISH) analysis if 2+ by immunohistochemistryXx_NEWLINE_xXTumors must be HER-2/neu expression negative, as determined by local hospital laboratory (immunohistochemistry [IHC] =< 2+ or fluorescence in situ hybridization [FISH] negative)Xx_NEWLINE_xXFemales with histologically or cytologically confirmed HER2-positive breast cancer. HER2-positive is defined as 3+ staining by immunohistochemistry or HER2 gene amplification by fluorescent in situ hybridization or silver in situ hybridization with HER2/CEP17 ratio ? 2.0Xx_NEWLINE_xXUnknown hormone-receptor statusXx_NEWLINE_xXThe invasive cancer must be estrogen receptor alpha (ER)-positive, with ER staining present in greater than 50% of invasive cancer cells by immunohistochemistry (IHC)Xx_NEWLINE_xXThe invasive cancer must be HER2-negative (IHC 0-1+, or with a fluorescence based in situ hybridization [FISH] ratio of < 1.8 if IHC is 2+ or if IHC has not been done)Xx_NEWLINE_xXHormone receptor status\r\n* Estrogen or progesterone receptor positive or\r\n* Estrogen and progesterone receptor negative and clinical tumor size =< 1.0 cmXx_NEWLINE_xXHuman epidermal growth factor receptor 2 (HER2)/neu negative on the core biopsy analysis defined as 0 or 1+ by immunohistochemistry or not amplified by fluorescent in situ hybridization analysisXx_NEWLINE_xXEstrogen receptor and progesterone receptor negative tumor with clinical size > 1 cmXx_NEWLINE_xXAny Her 2+ breast cancer (immunohistochemistry 3+; or amplified by fluorescence in situ hybridization [FISH])Xx_NEWLINE_xXInvasive breast cancer must be Her2-negative; if breast cancer is Her2 2+ by immunohistochemistry (IHC), then fluorescence in situ hybridization (FISH) must be negative for Her2 gene amplificationXx_NEWLINE_xXHER2-positive primary or metastatic tumor as assessed by central laboratoryXx_NEWLINE_xXPatient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancerXx_NEWLINE_xXPatients with 1) stage IV metastatic triple negative breast cancer (triple negative is defined as estrogen receptor [ER] and progesterone receptor [PgR] status is < 1% of tumor cell nuclei are immunoreactive for ER or PgR, and HER2 status is fluorescence in situ hybridization [FISH] negative or immunohistochemistry [IHC] 0 or 1+), or 2) stage IV HR+ HER2- (HR+) breast cancer (defined as ER or PgR > 1% of tumor cell nuclei are immunoreactive for ER or PgR and HER2 status is FISH negative or IHC 0 or 1+)Xx_NEWLINE_xXEstrogen receptor (ER)/progesterone receptor (PR) status (ER or PR defined as positive if >= 1%; ER/PR is defined as negative if 0%): \r\n* PHASE I: Patients may have ER/PR(+) or negative (-) breast cancer; ER(+) patients must have progression of disease following 1 prior line of endocrine therapy; progression of disease within 6 months of adjuvant endocrine therapy will be considered 1 line of prior endocrine therapy\r\n* PHASE II: Patients must have ER/PR(-) breast cancerXx_NEWLINE_xXHuman epidermal growth factor receptor 2 (HER2) normal (immunohistochemistry [ICH] 0-1; fluorescence in situ hybridization [FISH] < 2.0)Xx_NEWLINE_xXPatients with histologically confirmed invasive breast cancer that is: triple negative (estrogen receptor [ER] < 10%, progesterone receptor [PR] < 10%, and human epidermal growth factor receptor 2 (HER2) 0/1+ or 2+/fluorescence in situ hybridization [FISH] not amplified)Xx_NEWLINE_xXEstrogen receptor (ER) and progesterone receptor negative (a tumor is ER and/or progesterone receptor positive if at least 1 percent (%) of the cells examined have estrogen and/or progesterone receptors) and human epidermal growth factor receptor 2 (HER2) negative (defined as immunohistochemistry [IHC] less than (<) 2+ or fluorescence in situ hybridization [FISH] negative).Xx_NEWLINE_xXPatients with stage II-III breast cancer that is HER2-negative by immunohistochemistry (IHC) (0-2+) or fluorescence in situ hybridization (FISH) (HER2/chromosome enumeration probe [CEP]17 amplification ratio < 2.0) who have completed “third generation” neoadjuvant chemoT and planned local treatment (surgery and radiation if indicated); estrogen receptor (ER) or progesterone receptor (PR) status can be ER negative (=< 10% by IHC) or PR negative (=< 10% by IHC)Xx_NEWLINE_xXTumor determined to be HER2-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (HER2/CEP17 amplification ratio >= 2.0); tumors determined to be ER or PR positive by immunohistochemistry (> 10% )Xx_NEWLINE_xXTumors must express ER positivity by immunohistochemistry (ER expression >10% by immunohistochemistry).Xx_NEWLINE_xXPatient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testingXx_NEWLINE_xXPatient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0 or 1+ as per local laboratory testingXx_NEWLINE_xXKnown human epidermal growth factor 2 (HER2)-positive, estrogen receptor (ER)-positive, or progesterone receptor (PgR)-positive breast cancerXx_NEWLINE_xXHistological confirmation of triple negative breast cancer (TNBC) on outside or Duke University Health System (DUHS) biopsy report based on diagnostic biopsy and defined as:\r\n* Estrogen receptor negative (ER-) and progesterone receptor (PR)-negative: < 10% staining by immunohistochemistry (IHC)\r\n* HER2-negative disease, defined as IHC 0-1+ or non-amplified fluorescence in situ hybridization (FISH < 2.0)Xx_NEWLINE_xXSubjects must have HER2-positive tumors and written clinical pathology report documentation of HER2 status available for Sponsor's Medical Monitor review.Xx_NEWLINE_xXEstrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancerXx_NEWLINE_xXHER2-positive tumor (primary tumor or metastatic lesion) as confirmed by central\n             laboratory HER2 testing (immunohistochemistry and/or in-situ hybridization)Xx_NEWLINE_xXHER2 positive as determined by score of 3 on immunohistochemistry (IHC) staining or gene amplification by fluorescence in situ hybridization (FISH).Xx_NEWLINE_xXHER2/neu gene amplification by fluorescence, chromogenic or silver in situ hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per nucleus or a FISH, CISH or SISH HER2 gene copies to chromosome 17 signal ratio of ?2.0]Xx_NEWLINE_xXInoperable estrogen receptor positive and HER2 negative breast cancer.Xx_NEWLINE_xXHER2 positive by 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines (immunohistochemistry [IHC] 3+ and/or fluorescence in situ hybridization [FISH] positive; IHC 2+ HER2 patients are eligible with reflex FISH positive testing with the ratio >= 2.0) breast cancer patients with untreated asymptomatic or minimally symptomatic brain metastasis by MRI; there is no upper or lower limit to the size or number of brain metastasesXx_NEWLINE_xXLocal histologic or cytologic confirmation of HER2+ solid tumors by fluorescent in situ hybridization (FISH) amplification or immunohistochemistry (IHC) (3+)Xx_NEWLINE_xXSubjects with a primary tumor that is hormone (estrogen, progesterone, or both) receptor-positive or receptor-negative are eligible.Xx_NEWLINE_xXHER2 Positive disease documented as FISH-positive and/or 3+ by IHC on previously collected tumor tissue.Xx_NEWLINE_xXWomen with ER+/progesterone receptor positive (PR+) human epidermal growth factor receptor 2 (HER2)-negative breast cancer initiating neoadjuvant endocrine therapy with curative intent OR initiating endocrine therapy for the treatment of metastatic breast cancer with a biopsy accessible primary breast tumorXx_NEWLINE_xXPart A: Histological or cytological confirmation of a solid tumor and disease progression. Part B: Histological or cytological confirmation of ER positive, HER2 negative breast cancer and disease progression or any other solid tumor with a PIK3CA gene mutation. Part C: Histological or cytological confirmation of ER positive, HER2 negative postmenopausal breast cancer with locally advanced or metastatic disease that is eligible for fulvestrant treatment. Part D: Histological or cytological confirmation of ER positive, HER2 negative postmenopausal breast cancer with locally advanced or metastatic disease that is eligible for fulvestrant treatment. Patients must also present with a tumor related mutation of the PIK3CA gene.Xx_NEWLINE_xXPatients with estrogen receptor positive (ER+) breast cancer being treated with hormonal therapy (selective estrogen receptor modulator or aromatase inhibitor) who have rising tumor markers as evidence of disease progression or metastatic disease on scans may continue on hormonal therapy while being treated with vaccineXx_NEWLINE_xXPatients with Her2+ breast cancer receiving Her2-directed therapy (e.g. trastuzumab) may continue on that therapy when enrolling into a dose level for which safety has been establishedXx_NEWLINE_xXPatients with estrogen receptor (ER)+ breast cancer must have received prior treatment with at least one hormone therapyXx_NEWLINE_xXPatients are required to have HER2+ breast cancer defined as a fluorescent in situ hybridization (FISH)- ratio of >= 2.0 or immunohistochemistry (IHC) 3+Xx_NEWLINE_xXDiagnosis of TNBC: < 1% cells positive for ER/progesterone receptor, and HER2 IHC score of 0 or 1, or FISH HER2+ ratio of less than 1.8; patients with low ER IHC (> 1% but < 10% cells positive), but negative by genomic assay are eligibleXx_NEWLINE_xXHistologically confirmed adenocarcinoma of the breast, with sufficient tissue available for estrogen receptor (ER), progesterone receptor (PR), and HER 2 testing\r\n* HER2 must be positive by immunohistochemistry (IHC) or in situ hybridization (ISH) testing by laboratory standard.Xx_NEWLINE_xXTumor negative for HER2 expression (0 or 1+ by immunohistochemistry [IHC]) or negative fluorescent in situ hybridization (FISH) testingXx_NEWLINE_xXFor participants with breast cancer: HER2-negative disease as defined by local clinical guidelinesXx_NEWLINE_xXEvidence of HER2 oncoprotein expression at the 2+ level by central laboratory. Patients whose tumors exhibit 2+ staining by IHC are eligible for the study.Xx_NEWLINE_xXEvidence of lack of HER2 oncogene amplification as determined by FISH testing by central laboratoryXx_NEWLINE_xXHER2-positive disease documented as in situ hybridization (ISH)-positive and/or 3+ by immunohistochemistry (IHC) on previously collected tumor tissueXx_NEWLINE_xXER and/or PR-positive disease. Tumors must be HER-2/neu negative or equivocal.Xx_NEWLINE_xXPresence of tissue sample for IHC assay of MET receptor and HER2 statusXx_NEWLINE_xXPatients must have histologically or cytologically diagnosed locally advanced or metastatic triple-negative breast cancer defined as negative for estrogen receptor, progesterone receptor and HER2.Xx_NEWLINE_xXPatients must be ER >= 1% and HER2 negative on local testingXx_NEWLINE_xXTriple negative breast cancer (TNBC) Cohort: Participants with histologically confirmed incurable, advanced estrogen receptor (ER)-negative, progesterone receptor-negative, and human epidermal growth factor receptor 2 (HER2)-negative adenocarcinoma of the breast (triple-negative) not previously treated with anti-PD-L1/PD-1 and/or anti-CTLA-4 (investigational or approved)Xx_NEWLINE_xXHER2 negative disease, and a known positive hormone receptor status (common breast cancer classification tests)Xx_NEWLINE_xXHER2-positive as assessed by local laboratory on primary or metastatic tumorXx_NEWLINE_xXFor Stage 2: Participants with human epidermal growth factor receptor 2 (HER2) negative, estrogen-receptor (ER) negative, and progesterone-receptor (PR) negative breast cancerXx_NEWLINE_xXEstrogen receptor (ER)-positive disease and human epidermal receptor 2 (HER2)-negative diseaseXx_NEWLINE_xXEstrogen receptor (ER)/progesterone receptor (PR) positive tumor (as confirmed by City of Hope Pathology Department if done on the outside) orXx_NEWLINE_xXPatients with HER2-positive disease must have progressed on or following trastuzumabXx_NEWLINE_xXInvasive breast cancer must be estrogen receptor (ER)/progesterone receptor (PR)-negative (defined as less than 10% positivity by immunohistochemistry [IHC]), and human epidermal growth factor 2 (Her2)-negative; if breast cancer is Her2 2+ by IHC, then fluorescence in situ hybridization (FISH) must be negative for Her2 gene amplificationXx_NEWLINE_xXThe following receptor status:\r\n*Expansion: Triple negative (estrogen receptor [ER] < 1%, progesterone receptor [PR] <1%, and Her-2/neu negative)\r\n* Phase I (closed): Negative Her-2/neu statusXx_NEWLINE_xXCandidate for hormonal therapy (estrogen receptor [ER] and/or progesterone receptor [PR]-positive at primary diagnosis and at metastatic diagnosis where tissue is available)Xx_NEWLINE_xXHER2/neu-negative breast cancer by standard criteria (immunohistochemistry [IHC] < 3+ or fluorescence in situ hybridization [FISH]-negative if IHC 3+) at primary diagnosisXx_NEWLINE_xXMust have a biopsy in the metastatic setting with HER2 expression of 1+ or 2+ by IHCXx_NEWLINE_xXIf biopsy of metastatic lesion is performed prior to study entry, HER2 expression by IHC must be 1+ or 2+Xx_NEWLINE_xXHER2 0 or 3+ by IHC on pre-treatment biopsy of metastatic lesion (if performed)Xx_NEWLINE_xXPre-treatment biopsy with the following characteristics:\r\n* Hormone receptor-positive cancer as defined as estrogen receptor (ER) and/or progesterone receptor (PR)-positive by standard immunohistochemistry (IHC)\r\n* Human epidermal growth factor receptor 2 (HER2)-negative (HER2 =< 2 by IHC; if HER2 2+ by IHC must be fluorescence in situ hybridization [FISH] non-amplified)\r\n* Recurrence score >= 25 using Oncotype DX 21-gene assayXx_NEWLINE_xXEstrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancerXx_NEWLINE_xXHistologically proven diagnosis HER2-positive breast cancer; Her2-positive is defined as follows:\r\n* Validated immunohistochemistry (IHC) assay score of 3+ (defined as uniform, intense staining of > 30% of invasive tumor cells)\r\n* Average HER2 gene copy number of > 6\r\n* Gene amplified (HER2:D17Z1 ratio > 2.20)Xx_NEWLINE_xXPHASE I: Hormone receptor positive tumor defined as any positivity of estrogen or progesterone receptorXx_NEWLINE_xXPHASE II: Hormone receptor positive tumor defined as any positivity of estrogen or progesterone receptorXx_NEWLINE_xXParticipants must have HR positive, HER2-negative breast cancer (estrogen receptor [ER] > 1% and/or, progesterone receptor [PR] > 1%, HER2-negative per American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines, 2013 resulted on the primary tumor and/or a metastatic lesion)Xx_NEWLINE_xXTumors that are Her2 positive are eligibleXx_NEWLINE_xXProgressive HER2 positive solid tumours (immunohistochemistry [IHC] positive or equivocal) with no available standard or curative treatment.Xx_NEWLINE_xXPatients must have histologically confirmed operable triple negative breast cancer\r\n* Estrogen receptor (ER) and progesterone receptor (PR) expression must be < 1%\r\n* HER2 must negative as shown be either 0 or 1+ by immunohistochemistry (if 2+, in situ hybridization method used to define HER2) OR by a HER2: 17 centromere signal of < 2.0 using a standard in situ hybridization methodXx_NEWLINE_xXHave stage I-III estrogen receptor positive (ER+) breast cancerXx_NEWLINE_xXIf receiving neoadjuvant chemotherapy, must not be triple negative (estrogen receptor [ER]-/progesterone receptor [PR]-/HER2-)Xx_NEWLINE_xXMust have BOTH estrogen receptor (ER) and progesterone receptor (PR)-positive tumors and BOTH must be >= 26% positive; alternatively, if ER and PR are determined by Allred score, the score needs to be 5 or higherXx_NEWLINE_xXPatients must be women with histologically confirmed estrogen receptor (ER)- and/or progesterone receptor (PgR)-positive invasive carcinoma of the breast (Stage I-III) with no evidence of metastatic disease (M0)Xx_NEWLINE_xXAny receptor statusXx_NEWLINE_xXStage I-III estrogen receptor positive breast cancer (positive for estrogen receptor [ER] with positivity defined as immunohistochemical staining in >= 10% of cells) on adjuvant hormonal therapy with aromatase inhibitors (anastrozole, letrozole or exemestane)Xx_NEWLINE_xXHER2 expression as defined by ISH positive and/or 3+ by immunohistochemistry (IHC)Xx_NEWLINE_xXHER2 expression as defined by ISH positive and/or 3+ by immunohistochemistryXx_NEWLINE_xXDose expansion: patients must have histologically or cytologically confirmed invasive adenocarcinoma of the breast (human epidermal growth factor receptor 2 [HER2]-negative) that is locally advanced/metastatic and has progressed despite standard therapy; at least 1 prior chemotherapy regimen in the metastatic setting, and two lines of hormonal therapy (administered in the adjuvant or metastatic setting) for patients with hormone receptor-positive disease; NOTE: HER2-negativity will be defined per American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines; patients whose tumors have HER2 immunohistochemistry (IHC) 3+, in situ hybridization (ISH) >= 2.0, or average HER2 copy number >= 6.0 signals per cell are not eligibleXx_NEWLINE_xXThe invasive tumor must be hormone receptor-poor, defined as both estrogen receptor (ER) and progesterone receptor (PgR) staining present in =< 10% of invasive cancer cells by immunohistochemistry (IHC)Xx_NEWLINE_xXHuman epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer by local laboratory testing (immunohistochemistry [IHC] 3+ staining or fluorescent in situ hybridization [FISH] positive)Xx_NEWLINE_xXPatients must be positive for either estrogen receptor (ER) and/or progesterone receptor (PgR) as determined by institutional standardXx_NEWLINE_xXHormone receptor status not specifiedXx_NEWLINE_xXDiagnosed with triple negative (negative for estrogen receptor, progesterone receptor and not human epidermal growth factor receptor 2 [Her2] amplified) breast cancer at 60 or youngerXx_NEWLINE_xXPatients with non-metastatic, node positive, HER2 negative breast cancer, confirmed by pathology report, who are in remission and defined as having no evidence of disease (NED); HER2 negative is defined as\r\n* 0-1+ HER2 expression by immunohistochemistry (IHC) OR\r\n* Fluorescence in situ hybridization (FISH) negative OR\r\n* HER2 2+ and FISH negativeXx_NEWLINE_xXPrior diagnosis of stage 0 to III breast cancer that is estrogen receptor negative, progesterone receptor negative with completion of definitive surgery, radiation therapy and/or chemotherapyXx_NEWLINE_xXPatients will be included in the study based on the following criteria:\n\n          -  Women 18 years or older\n\n          -  Node-positive breast cancer (AJCC N1, N2, or N3)\n\n          -  Node-negative breast cancer if negative for both estrogen (ER) and progesterone (PR)\n             receptors and have received chemotherapy as standard of care\n\n          -  Clinically cancer-free (no evidence of disease) after standard of care therapy\n             (surgery, chemotherapy, radiation therapy as directed by NCCN guidelines). Hormonal\n             therapy will continue per standard of care. Neoadjuvant chemotherapy is allowed.\n\n          -  Recovery from any toxicity(ies) associated with prior adjuvant therapy.\n\n          -  HER2 expression of 1+ or 2+ by IHC. FISH or Dual-ISH testing must be performed on IHC\n             2+ tumors and shown to be non-amplified by FISH (?2.0) or by Dual-ISH (?2.0).\n\n          -  HLA-A2, A3, A24, or A26 positive\n\n          -  LVEF >50%, or an LVEF within the normal limits of the institution's specific testing\n             (MUGA or Echo)\n\n          -  ECOG 0,1\n\n          -  Signed informed consent\n\n          -  Adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral\n             tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)\n\n          -  Must start study treatment (receive first Herceptin infusion) 15between 3-12 weeks\n             from completion of standard of care therapy.\n\n        4.1.3 Exclusion Criteria\n\n        Patients will be excluded from the study based on the following criteria:\n\n          -  Node-negative breast cancer (AJCC N0 or N0(i+)) unless negative for both estrogen (ER)\n             and progesterone (PR) receptors and has received chemotherapy as standard of care\n\n          -  Clinical or radiographic evidence of distant or residual breast cancer\n\n          -  HER2 negative (IHC 0) or HER2 3+ or FISHDual-ISH amplified (FISH >2.0); Dual-ISH >2.0\n\n          -  HLA-A2, A3, A24, A26 negative\n\n          -  History of prior Herceptin therapy\n\n          -  NYHA stage 3 or 4 cardiac disease\n\n          -  LVEF <50%, or less than the normal limits of the institution's specific testing (MUGA\n             or Echo)\n\n          -  Immune deficiency disease or HIV, HBV, HCV\n\n          -  Receiving immunosuppressive therapy including chemotherapy, chronic steroids,\n             methotrexate, or other known immunosuppressive agents\n\n          -  ECOG ?2\n\n          -  Tbili >1.8, creatinine>2, hemoglobin<10, platelets<50,000, WBC<2,000\n\n          -  Pregnancy (assessed by urine HCG)\n\n          -  Breast feeding\n\n          -  Any active autoimmune disease requiring treatment, with the exception of vitiligo\n\n          -  Active pulmonary disease requiring medication to include multiple inhalers\n\n          -  Involved in other experimental protocols (except with permission of the other study\n             PI)Xx_NEWLINE_xXSubjects with invasive breast cancer at least stage IIIA >= N2 (> 4 positive nodes) or have recurrent metastatic breast cancer rendered no evidence of disease (NED) by any means that are classic HER-2 3+ 10%, 2+ immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) positive or HER-2 2+ FISH negative that have completed chemotherapy and/or trastuzumab and have no evidence of diseaseXx_NEWLINE_xXThe study will be conducted in women who have been diagnosed with a first primary invasive estrogen receptor (ER) positive (+) breast cancer (stages I-IIIa) who are within the first 3 years post-treatmentXx_NEWLINE_xXThe patient was proven to have TNBC, defined from standard pathologic assays as negative for ER and PR (< 10% tumor staining) and negative for HER2 (immunohistochemistry [IHC] score < 3, gene copy number not amplified)Xx_NEWLINE_xXDocumentation of histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative adenocarcinoma of the breast must be available.Xx_NEWLINE_xXHistologically confirmed advanced solid tumors with HR-positivity defined as > 1% on immunohistochemistry (estrogen receptor-positive with or without positivity for the progesterone receptor) and HER2/neu positivity (3+ on IHC and/or 2+ on IHC and FISH amplified, or by v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2 [ERBB2] mutation on next generation sequencing)Xx_NEWLINE_xXPostmenopausal, Estrogen-receptor positive and/or Progesterone-receptor positive breast cancerXx_NEWLINE_xXPrimary tumor must be triple negative breast cancer (i.e., the invasive tumor must be estrogen receptor [ER]-negative and progesterone receptor [PR]-negative, or stain < 10% by immunohistochemistry [IHC]; the invasive tumor must be HER2-negative, defined as 0 or 1+ by IHC or fluorescent in situ hybridization [FISH] < 2.0)Xx_NEWLINE_xXPatients with triple negative breast cancer (estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), and human epidermal growth factor receptor 2-negative (Her2-) must also meet the following criteria: a. Must have received at least one prior chemotherapy regimen for locally advanced or metastatic disease; b. Must have received prior taxane therapy.Xx_NEWLINE_xXHER2 negative disease based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER2 status.Xx_NEWLINE_xXParticipants must have biopsy proven localized estrogen receptor (ER) positive (+) (>= 10%), HER2 negative, any grade, invasive breast adenocarcinoma, with pathological stage (including post-neoadjuvant therapy) T1c-T4c, any N, M0, by American Joint Committee on Cancer (AJCC) seventh (7th) edition staging; invasive breast cancer must be ER+ in >= 10% of the cells and HER2 negative (immunohistochemistry [IHC] 0 or 1+ and/or fluorescence in situ hybridization [FISH] negative with a ratio < 2) by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; for IHC 2+, the tumor must be FISH negative with a ratio < 2; progesterone receptor (PR) status must be performed; ER, PR and HER2 measurements should be performed according to institutional (local) guidelines, in a Clinical Laboratory Improvement Act (CLIA)-approved setting; evaluation for metastatic disease is not required in the absence of symptoms; patients must have completed definitive surgery for breast cancerXx_NEWLINE_xXEstrogen receptor- or progesterone receptor-negative diseaseXx_NEWLINE_xXHER2/neu-expressing tumor (immunohistochemistry [IHC] 3+ and/or amplified fluorescence in situ hybridization [FISH] >2.2, or N0 (i+))Xx_NEWLINE_xXHER2/neu-expressing tumor (IHC 1-3+ and or positive FISH >1.2)Xx_NEWLINE_xXHER2/neu-negative breast cancers (IHC 0)Xx_NEWLINE_xXHistological or cytological confirmation of hormone-receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancerXx_NEWLINE_xXHER2 negative (HER2 1+ by IHC or HER2 2+ by IHC/FISH)Xx_NEWLINE_xXPatients must have had ER analysis performed on the primary breast tumor collected prior to neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testingXx_NEWLINE_xXPatients must have had HER2 testing performed on the primary breast tumor collected prior to neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer; patients who have a primary tumor that is HER2-positive, HER2-equivocal, or HER2-negative are eligibleXx_NEWLINE_xXPatients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicatedXx_NEWLINE_xXPatients must have either:\r\n* Estrogen receptor (ER) negative/progesterone receptor (PR) negative (< 10% by immunohistochemistry [IHC] staining) and HER-2 negative breast cancer OR\r\n* ER negative/PR negative (< 10% by IHC staining) and HER-2 positive tumors\r\n* HER2 status will be determined per the 2013 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines:\r\n** HER2 is considered positive if a) there is IHC 3+ staining or b) positive using either single probe in situ hybridization (ISH) or dual probe ISH\r\n** HER2 is considered negative if a) there is IHC 0 or 1+ staining or b) ISH negative using either single probe ISH or dual probe ISH\r\n* For patients enrolling after neoadjuvant therapy, the ER, PR, and HER2 markers are based on assessment prior to initiating neoadjuvant treatmentXx_NEWLINE_xXPrimary tumor and/or metastatic site must be ER+ and may be progesterone-receptor positive (PgR+) or progesterone-receptor negative (PgR-) by IHC; patients with a history of an estrogen-receptor negative (ER-) primary tumor and a documented ER+ metastatic site are eligibleXx_NEWLINE_xXThe patient has proven TNBC, defined by standard pathologic assays as negative for estrogen receptor (ER) and progesterone receptor (PR) (< 10% tumor staining) and negative for human epidermal growth factor 2 (HER2) (immunohistochemistry [IHC] score < 3, gene copy number not amplified)Xx_NEWLINE_xXHistologically-confirmed invasive triple negative breast cancer (estrogen receptor [ER] < 1%, progesterone receptor [PR] < 1%, human epidermal growth factor receptor 2 [her-2-neu] 0-1+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH]-negative) or as determined by Doctor of Medicine (MD) discretionXx_NEWLINE_xXConfirmed histologic diagnosis of operable HER2 overexpressing (ER < 10%, progesterone receptor [PR] < 10%, and HER2 2+ or fluorescence in situ hybridization [FISH] amplified) OR triple negative (ER < 10%, PR < 10%, and HER2 0/1+ or 2+/FISH not amplified) OR ER positive invasive ductal breast cancer, including Memorial Sloan Kettering Cancer Center (MSKCC) pathology confirmationXx_NEWLINE_xXEstrogen receptor (ER) receptor positive on core needle biopsy, or if receptor negative, have evaluable ER receptor with positive internal control on core biopsyXx_NEWLINE_xXProgesterone receptor (PR) positive on core needle biopsy if biopsy indicates invasive cancer, or if receptor negative on biopsy indicating invasive cancer, have evaluable PR receptor with positive internal control on core biopsyXx_NEWLINE_xXHER2 immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) ordered on core biopsy, if biopsy indicates invasive cancer; Oncotype DX or other deoxyribonucleic acid (DNA) testing performed on core biopsy or not requestedXx_NEWLINE_xXNo or equivocal ER, PR or HER2 testing performed prior to surgery if biopsy indicates invasive cancerXx_NEWLINE_xXPatient must have any one of the following types of breast cancer (primary or metastatic): estrogen receptor (ER)+/PgR+/human epidermal growth factor receptor 2 negative (HER2-) or ER+/PgR-/HER2-\r\n* ER+ is defined as Allred score of at least 4 and greater\r\n* PgR+ is defined as Allred score of at least 4 and greater\r\n* IHC is the primary assay methodology for HER2; HER2- refers to HER2 of 0, 1+ by IHC or negative by fluorescence in situ hybridization (FISH)Xx_NEWLINE_xXHistory of HER2/neu positive cancer (IHC 3+ and/or fluorescence in situ hybridization [FISH] positive) as assessed by medical record review at screeningXx_NEWLINE_xXPathologically or cytologically confirmed metastatic or primary esophagogastric cancer; HER2 positive status by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) as currently being implemented for patients with esophagogastric cancer; HER2 overexpression and/or amplification as determined by IHC (3+) or FISH (>= 2.0)Xx_NEWLINE_xXAdult patients with a history of pathologically confirmed estrogen receptor positive (ER+) breast cancerXx_NEWLINE_xXPatients with histologic/immunochemical proof of estrogen receptor (ER)+ primary or metastatic malignancy (positive staining in >= 1% of cells by immunohistochemistry)Xx_NEWLINE_xXTwo patients must be HER2 3+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) positiveXx_NEWLINE_xXHistologically proven infiltrating carcinoma of the breast on core needle biopsy that is:\r\n* ER/progesterone receptor (PR) =< 10% staining by immunohistochemistry (IHC)\r\n* HER2 positive – IHC 3+, in situ hybridization (ISH) >= 2.0, or average HER2 copy number >= 6.0 signals per cell or per current ASCO-CAP (American Society of Clinical Oncology – College of American Pathologists) or NCCN (National Comprehensive Cancer Network) guidelines\r\n* Note: All histological diagnostic material should be reviewed at enrolling institution as required per local standardsXx_NEWLINE_xXThe cancer must over express HER2 as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH)Xx_NEWLINE_xXCohort 1: Her2-positive (defined as 3+) or fluorescence in situ hybridization (FISH) HER2:Chromosome 17 centromere (CEP17) ratio > 2 biopsy-proven breast cancerXx_NEWLINE_xXCohort 2: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio > 2 OR HER2-negative (0 or 1+, 2+ and FISH negative) biopsy-proven breast cancerXx_NEWLINE_xXHistologically confirmed HER2+ breast cancer: immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) amplified; by clinical assay on either primary or metastatic tumorXx_NEWLINE_xXClinical stage IV ER, PR, HER2 negative invasive mammary carcinoma, previously documented by histological analysis and that meets the following criteria:\r\n* HER2 negativity is defined as any of the following by local laboratory assessment: in-situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell), or IHC 0 or IHC 1+ (if more than one test result is available and not all results meet the inclusion criterion definition, all results should be discussed with the protocol chair to establish eligibility of the patient)\r\n* ER and PR negativity are defined as =< 10% of cells expressing hormonal receptors via IHC analysisXx_NEWLINE_xXHigh risk ductal carcinoma in situ (DCIS) or invasive stage I and II estrogen receptor (ER) positive (+)/progesterone receptor (PR)+ breast cancer with negative clinical lymph node examXx_NEWLINE_xXAny biopsy proven HER2-positive malignancy; American Society of Clinical Oncology (ASCO) guidelines will be used to define HER2-positivity for breast cancer; similar guidelines will be used for other cancer types as appropriate; at least one malignant lesion on CT, magnetic resonance (MR), or fludeoxyglucose (FDG) PET/CT within 60 days of protocol enrollmentXx_NEWLINE_xXTumor HER2/neu expression must be determined (as part of standard clinical care) prior to study enrollment; HER2 may be tested by any Food and Drug Administration (FDA) approved HER2 testing method; if determination is intermediate by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or another alternate HER2 test must be performedXx_NEWLINE_xXHER2/neu positive by IHC and/or another FDA approved HER2 testing methodXx_NEWLINE_xXThe patient is receiving preoperative chemotherapy other than adriamyacin, cyclophosphamide, and a taxane (ACT) in standard or dose-dense fashion; herceptin may be added to the neoadjuvant chemotherapy regimen in cases where the tumor is Human Epidermal growth factor Receptor 2 (Her-2)/neu positive by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)Xx_NEWLINE_xXEstrogen receptor positive breast cancerXx_NEWLINE_xXParticipants must have biopsy proven invasive breast carcinoma stages T1cN0 to T3N0, estrogen receptor (ER) or progesterone receptor (PR) positive with tumors greater than 1 cm without lymph node spreadXx_NEWLINE_xXHistologically confirmed TNBC (i.e., estrogen receptor [ER] negative, progesterone receptor [PR] negative (each < 10% staining by immunohistochemistry) and human epidermal growth factor receptor 2 (Her2) negative (0-1+ or fluorescent in situ hybridization [FISH] nonamplified; by clinical assay on primary tumor)Xx_NEWLINE_xXPatients must have estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2) non-expressing breast cancer defined as:\r\n* < 1% of tumor nuclei that are immunoreactive for ER and PR\r\n* Fluorescence in situ hybridization (FISH) ratio of less than 2.0 or immunohistochemistry (IHC) staining of 0 or 1+Xx_NEWLINE_xXPHASE I: Women with estrogen receptor (ER)+, HER2-, lymph node (LN)-, breast cancers < 3 cm who were diagnosed with a first primary breast cancer > 6 months ago and < 2 years agoXx_NEWLINE_xXPHASE II: Women with a first primary ER+, HER2-, LN-, breast cancer < 3 cm immediately after their initial surgical consultationXx_NEWLINE_xXTumors must be estrogen and/or progesterone receptor positive according to ASCO/CAP 2010 guidelines as either ER or PR ? 1% positive nuclear staining by immunohistochemistry based on local laboratory results.Xx_NEWLINE_xXTumors must be HER2 negative as defined according to ASCO/CAP 2013, as HER2 0 - 1+ by IHC or non-amplified FISH or CISH. If HER2 IHC is 2+, FISH/CISH must be performed and must not be positive (HER2/CEP17 ratio must be < 2, and HER2 copy number < 6 signals/cell), but otherwise FISH/CISH is not required if IHC is 0 or 1+ by institutional standards.Xx_NEWLINE_xXPatients must have estrogen receptor (ER) positive, HER2 negative metastatic breast\n             cancer (MBC) with at least one non-irradiated distant site of metastasis.Xx_NEWLINE_xXTriple-negative disease (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) negativity confirmed on a histological biopsy of a metastatic tumor lesion (receptor conversion not allowed).Xx_NEWLINE_xXHistologically proven diagnosis of breast cancer with evidence of metastatic disease or locoregional recurrence. 3. Histological confirmation and documentation of estrogen receptor (ER)-positive status (?1% positive stained cells). 4. Histological or cytological confirmation and documentation of human epidermal growth factor receptor-2 (HER2)-negative status by local laboratory testing using criteria in the American Society of Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline update.Xx_NEWLINE_xX