Estrogen 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 appropriate
Any ER/progesterone receptor (PgR) status allowed
Estrogen 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)
* 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 >= 3
Estrogen 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 chemotherapy
Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
Metastatic 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 eligible
Participants 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 therapy
SAFETY 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])
Histologically documented TNBC (negative human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PgR] status)
Invasive 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 3
Histologically 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 disease
Patients 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 guideline
Patients 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 breast
Estrogen 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)
Documentation of estrogen receptor positive ((ER+), human epidermal growth factor receptor 2 (HER2 negative (HER2-)) tumor.
Histologically-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.
Human 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).
Any estrogen receptor (ER), progesterone receptor (PR), HER2 status
Estrogen 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
Subjects must be estrogen receptor (ER) positive
Has positive estrogen receptor (ER) or progesterone receptor (PR) status. ER or PR >= 10%.
Estrogen receptor (ER)+ Her2- breast cancer
Estrogen receptor (ER)+ Her2- breast cancer
Primary, 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 immunohistochemistry
Dose 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 staining
Estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor (? 1% positive stained cells) based on local laboratory results
Breast 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 resection
Patient 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 allowed
PHASE 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)
Estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) (HER2 status is not required for women diagnosed with DCIS)
Estrogen 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
Estrogen 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) discretion
Patients 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.)
COHORT II: Core biopsy demonstrating breast cancer and receptors that are estrogen receptor (ER) or progesterone receptor (PR) positive
COHORT II: Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy
Patients with progesterone receptor positive (PR+) tumors are allowed
Patients must have had histologically confirmed stage I-III breast carcinoma that is positive for estrogen receptor (ER) and/or progesterone receptor (PR)
Estrogen 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 therapy
Step 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)
Subjects 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)
Patient 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 -).
Immunohistochemical 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 2
Pathologically 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 disease
Estrogen receptor (ER) and progesterone receptor (PgR) status by IHC must be known; tumor must be ER and PR negative (=< 5% staining) by local review
Histologically and/or cytologically confirmed diagnosis of ER+ and/or progesterone receptor positive (PR+) breast cancer by local laboratory
Any estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel alone
Histologically 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)
Estrogen receptor (ER) and progesterone receptor (PgR) negative.
Estrogen receptor (ER)/progesterone receptor (PR) determination is required; ER- and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocol
Histologic 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 study
Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.
Estrogen 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 permitted
Patients 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 disease
Histological 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.
Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (PR) positive breast cancer
All positive or negative ER (estrogen receptor), PR (progesterone receptor), and HER-2 subjects are eligible for this study.
Documentation of ER-positive and/or progesterone receptor (PR)-positive tumor.
Breast tumors with hormone receptor positive disease (estrogen receptor [ER]+/progesterone receptor [PR]+, ER+/PR- regardless of HER2 status)
Men 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)
Tumors 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 accepted
Histologically 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 required
Patients 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 guidelines
Patients have positive estrogen receptor (ER) expression in the primary tumor site by immunohistochemistry (IHC) (defined as >= 10%) (progesterone receptor [PR] status is not required)
Histologically 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) status
Histologically or cytologically confirmed estrogen/progesterone receptors (ER/PR) +/-; human epidermal growth factor receptor 2 (HER2)-, metastatic breast cancer.
Histological or cytological confirmation of estrogen-receptor positive (ER+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer
Histologically 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) disease
At 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 enrolled
Patient 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 allowed
Histopathological 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 status
Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor [ER] and progesterone receptor [PR]) status and HER-2 status
Known human epidermal growth factor 2 (HER2)-positive, estrogen receptor (ER)-positive, or progesterone receptor (PgR)-positive breast cancer
Estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer
Women 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 tumor
Triple 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)
For Stage 2: Participants with human epidermal growth factor receptor 2 (HER2) negative, estrogen-receptor (ER) negative, and progesterone-receptor (PR) negative breast cancer
Estrogen receptor (ER)-positive disease and human epidermal receptor 2 (HER2)-negative disease
Estrogen receptor (ER)/progesterone receptor (PR) positive tumor (as confirmed by City of Hope Pathology Department if done on the outside) or
The 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 status
Candidate for hormonal therapy (estrogen receptor [ER] and/or progesterone receptor [PR]-positive at primary diagnosis and at metastatic diagnosis where tissue is available)
Have stage I-III estrogen receptor positive (ER+) breast cancer
If receiving neoadjuvant chemotherapy, must not be triple negative (estrogen receptor [ER]-/progesterone receptor [PR]-/HER2-)
Must 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 higher
Patients 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)
The 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)
Patients must be positive for either estrogen receptor (ER) and/or progesterone receptor (PgR) as determined by institutional standard
Diagnosed with triple negative (negative for estrogen receptor, progesterone receptor and not human epidermal growth factor receptor 2 [Her2] amplified) breast cancer at 60 or younger
Patients 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.
Primary 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 eligible
Estrogen receptor (ER) receptor positive on core needle biopsy, or if receptor negative, have evaluable ER receptor with positive internal control on core biopsy
Progesterone 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 biopsy
Adult patients with a history of pathologically confirmed estrogen receptor positive (ER+) breast cancer
High 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 exam
Participants 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 spread
Tumors 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.
Triple-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).