Patients must have had estrogen receptor, progesterone receptor and HER 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 HER status has not been clearly determined (i.e. equivocal/indeterminate), then patients should not be enrolled
Patients must have histologically documented unresectable stage III or IV triple negative breast cancer (TNBC) and a known BRCA / mutation present; TNBC patients must be Her- negative, estrogen receptor (ER) negative (defined as less than % ER by immunohistochemistry [IHC]) and progesterone receptor (PR) negative breast cancer (defined as less than % PR staining by IHC)
Newly diagnosed triple negative breast cancer (TNBC) clinical stage Ic, II, or III\r\n* Estrogen receptor (ER) and progesterone receptor (PR) < %\r\n* HER negative based on one of the following:\r\n** Immunohistochemistry (IHC)  or +\r\n** IHC + and fluorescence in situ hybridization (FISH) negative\r\n** IHC + and FISH equivocal and no indication for HER targeted therapy based on the treating investigators discretion (i.e., HER: CEP ratio < . or HER total copy number < )
The following disease subtypes are eligible:\r\n* Triple negative disease (defined as estrogen receptor [ER] < %, progesterone receptor [PR] < %, HER negative)\r\n* Hormone receptor positive, HER negative disease with evidence of progression on at least two prior lines of hormone therapy\r\n* HER positive disease with evidence of disease progression on trastuzumab, pertuzumab, T-DM and oral tyrosine kinase inhibitor unless contraindicated with no other HER targeted therapy options available (patients in this category will be classified by ER status)\r\n** Histologically confirmed HER+ breast carcinoma, with HER+ 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  weeks of study entry to be >= institutional lower limit of normal (LLN) using echo or multigated acquisition scan (MUGA)
SAFETY RUN-IN: Hormone receptor status (ER and PR) both =< % by immunohistochemistry, and HER status confirmed by means of immunohistochemistry (with  or + indicating negative status) or fluorescence in situ hybridization (with amplification ratio < . indicating negative status)
RANDOMIZED PHASE II CLINICAL TRIAL: Hormone receptor status (ER and PR) both =< % by immunohistochemistry, and HER status confirmed by means of immunohistochemistry (with  or + indicating negative status) or fluorescence in situ hybridization (with amplification ratio < . indicating negative status)
Histologically confirmed triple negative breast cancer (estrogen receptor [ER] < %, progesterone receptor [PR] < %, Herneu immunohistochemistry [IHC]  or  or fluorescence in situ hybridization [FISH]/in situ hybridization [ISH] negative)
Either 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 < % by immunohistochemistry (IHC)\r\n* HER-negative:  or + by IHC, or fluorescence in situ hybridization (FISH) < .
All 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) >= % of tumor staining >= + intensity\r\n* Endometrial >= % of tumor staining >= + intensity\r\n* TNBC confirmed by medical history of HER-negative (confirmed by IHC , + regardless of fluorescence in situ hybridization [FISH] ratio; IHC + with FISH ratio < . or HER gene copy < .; FISH ratio of , indicating gene deletion; when positive and negative in situ hybridization controls are present); estrogen receptor (ER) negative (confirmed as ER expression =< % positive tumor nuclei); progesterone receptor (PR) negative (confirmed as PR expression =< % positive tumor nuclei): >= % of tumor staining >= + intensity
Triple-negative breast cancer (defined as estrogen receptor [ER] and progesterone receptor [PR] < % positive; HER -+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] ratio < .)
Clinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is:\r\n* ER/progesterone receptor (PR)-positive (> % cells) by immunohistochemistry (IHC) and HER 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 CDK/ inhibitor\r\n* Appropriate candidates for chemotherapy\r\n* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version . 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.
Core biopsy proven estrogen negative (< %), progesterone negative (< %), and HER-neu negative (+ by immunohistochemistry and/or fluorescence in situ hybridization [FISH] ratio < .) invasive breast cancer
Confirmed invasive triple-negative breast cancer defined as estrogen receptor (ER) < %; progesterone receptor (PR) < % by immunohistochemistry (IHC) and HER -+ by IHC or +, fluorescence in situ hybridization (FISH) < , gene copy number < 
Patients 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] < %, progesterone receptor [PR] < % and HER + or less by immunohistochemistry [IHC]; if HER- expression is +, a negative fluorescence in situ hybridization [FISH] testing is required) (c) pancreatic adenocarcinoma (PDAC), or (d) small cell lung cancer (SCLC)
Histological confirmation of triple negative breast cancer defined as:\r\n* Her/neu by fluorescence in situ hybridization (FISH) (ratio =< .) or immunohistochemistry (IHC) ( or +)\r\n* Estrogen receptor (ER) and progesterone receptor (PR) expression < %
Histologically proven invasive breast carcinoma with triple negative receptor status (estrogen receptor, progesterone receptor and HER negative by immunohistochemistry [IHC] and/or fluorescence in situ hybridization [FISH]); patients who are weekly positive for the estrogen or progesterone receptor (i.e. =< %) are eligible
HER positive (immunohistochemistry [IHC] + and or fluorescence in situ hybridization [FISH] amplified) or triple receptor negative (triple negative [TN], estrogen receptor [ER]/progesterone receptor [PR] < % HER negative [IHC + or + FISH non-amplified]) receiving any standard routine clinical NST regimen
New diagnosis of invasive cyclin D +, estrogen receptor (ER)+, progesterone receptor (PR) +/-, Her- breast cancer\r\n* Cyclin D positive as defined as a total immunohistochemical score of  or greater\r\n* Hormone receptor positive as defined as >= % positive stained cells\r\n* HER-normal (immunohistochemistry [IHC] score - or fluorescence in situ hybridization [FISH] negative [in-situ hybridization (ISH) ratio =< . status])
Patients must have histologically or cytologically confirmed clinical stage T- N- triple negative (estrogen receptor/progesterone receptor < % HER - by immunohistochemistry [IHC] or unamplified by fluorescence in situ hybridization [FISH]) invasive ductal carcinoma
Patients must have histologically or cytologically confirmed stage I-III triple negative breast cancer\r\n* Estrogen receptor (ER) and progesterone receptor (PR) must be < % by standard assay methods\r\n* Human epidermal growth factor receptor  (HER) must be either , + by immunohistochemistry (if +, in situ hybridization method used to define HER) OR have HER:  centromere signal of < . using a standard in situ hybridization method
INCLUSION CRITERIA FOR TNBC: Histologically confirmed diagnosis of metastatic TNBC; i.e. breast cancer that is estrogen receptor (ER) negative (=< %), progesterone receptor (PR) negative (=< %), and human epidermal growth factor receptor  (HER) negative ( or + by immunohistochemistry or negative for gene amplification by fluorescence in situ hybridization [FISH])
Patients must have triple-negative breast cancer defined as estrogen receptor (ER) < %; progesterone receptor (PR) < % by immunohistochemistry (IHC) and human epidermal growth factor receptor  (HER) -+ by IHC or +, fluorescence in situ hybridization (FISH) non-amplified
Clinical stage IV invasive mammary carcinoma that is estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor  (HER) negative (triple negative) previously documented by conventional methods (immunohistochemistry [ISH], fluorescence in situ hybridization [FISH]); ER negative is defined as expression of ER in =< % cells, PR negative is defined as expression of PR in =< % cells, HER negative (acceptable methods of HER analysis include IHC [, +], fluorescence in situ hybridization [FISH] with HER/chromosome  centromere [CEN-] ratio < , and/or chromogenic in situ hybridization [CISH] with HER/CEN- ratio < ), as previously documented by histological analysis
Triple-negative breast cancer defined as estrogen receptor (ER) < %; progesterone receptor (PR) < % by immunohistochemistry (IHC) and human epidermal growth factor receptor  (HER) - positive (+) by IHC or +, fluorescence in situ hybridization (FISH) < , gene copy number < 
Patients must have a histologically documented (either primary or metastatic site) diagnosis of breast cancer that is HER non-overexpressing by immunohistochemistry, namely  or ; if they have an equivocal immunohistochemistry, , the tumor must be non-gene amplified by fluorescence in situ hybridization (FISH) performed upon the primary tumor or metastatic lesion (ratio <  and HER copy number < ); estrogen receptor (ER) positivity is defined as % or greater; progesterone receptor (PR) positivity will be defined as a result of greater than %; documentation of ER and PR status should be available at registration; the expansion cohort will only include HER-negative, ER and PR-negative patients
Stage ,  or  invasive breast cancer which is triple negative; triple negative breast cancer is defined as estrogen receptor (ER) < %, progesterone receptor (PR) < % and HER  or + or fluorescence in situ hybridization (FISH) not amplified if IHC +
Confirmed invasive triple-negative breast cancer defined as estrogen receptor (ER) < %; progesterone receptor (PR) < % by immunohistochemistry (IHC) and human epidermal growth factor receptor  (HER) -+ (by IHC), or + (fluorescence in situ hybridization [FISH] < , gene copy number < )
Clinical T-Tc, any N, M invasive estrogen receptor positive (ER+) (Allred Score of -) and human epidermal growth factor receptor  negative (HER-) ( or + by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] negative for amplification) breast cancer by American Joint Committee on Cancer (AJCC) th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node; patients with Tc tumors are eligible if they are considered candidates for neoadjuvant endocrine therapy
Histologically documented metastatic or locally advanced unresectable breast cancer that is estrogen receptor (ER) and progesterone receptor (PR) < % expression and does not over-express HER protein (immunohistochemistry [IHC] , +, or + and fluorescence in situ hybridization [FISH] < .)
Must have histologically or cytologically confirmed triple negative (estrogen receptor [ER]-/progesterone receptor [PR]-/HER-) 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  or below for ER and PR\r\n** < % weakly positive staining for ER and PR\r\n* NOTE: HER- is defined as follows: \r\n** HER will be considered negative if scored  or + by immunohistochemistry (IHC) or + by IHC associated with a fluorescence in situ hybridization (FISH) ratio of < . or <  copies per cell
TNBC defined as ER and PR negative (<%) and HER- negative (FISH negative or IHC -+)
Clinical stage operable I, II or III invasive mammary carcinoma, which is estrogen receptor (ER)-positive by immunohistochemistry (IHC) and human epidermal growth factor receptor  (Her)-negative by Hercep test ( or +) or not overexpressed by fluorescent in situ hybridization (FISH)
PSTAT SCREENING: Patients must have known estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor  (HER) status defined as either:\r\n* Triple-negative breast cancer, defined as: ER and PR < % by immunohistochemistry, and HER-negative (defined as IHC  or +, or fluorescent in situ hybridization [FISH] ratio < .) (Note, in patients who have ER, PR, HER 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, HER status
Histologically proven HER- negative breast cancer (HER- negative defined as HER immunohistochemistry [IHC]  or + and/or HER- fluorescence in situ hybridization [FISH] negative); HER- negative breast cancer includes hormone positive (estrogen receptor [ER] and/or progesterone receptor [PR] positive) breast cancer and triple negative breast cancer (TNBC)
Have histologically confirmed invasive breast cancer that is estrogen receptor (ER) negative (=< %), progesterone receptor (PR) negative (=< %) and human epidermal growth factor receptor  (HER) normal (=< % of cells) by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)
Tumor must be human epidermal growth factor receptor  (HER--neu) negative (defined as  or + staining by immunohistochemistry or gene amplification ratio =< ., by fluorescent in situ hybridization [FISH]), estrogen and progesterone receptors negative (< %); patients with BRCA  or  mutations will NOT be included
Patients 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  (HER) negative; HER negative defined as immunohistochemistry (IHC)  or + or fluorescence in situ hybridization (FISH) negative\r\n* Her- negative hormone-refractory breast cancer which denotes progression on one or more endocrine therapies (e.g., tamoxifen, aromatase inhibitors, fulvestrant) unless contraindicated
Subject must have histologically confirmed stage IV TNBC (estrogen receptor [ER]-, progesterone receptor [PR]-, HER-negative) and have received at least  prior line of systemic therapy\r\n* ER- and PR-negative: defined as < % staining by immunohistochemistry (IHC)\r\n* HER-negative disease, defined as IHC -+ or fluorescence in situ hybridization (FISH) ratio < .
Histologically or cytologically-confirmed triple-negative breast cancer (TNBC) (defined as estrogen receptor [ER] < %, progesterone receptor [PR] < %, human epidermal growth factor receptor  [her-]-neu -+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH]-negative or as per doctor of medicine [MD] discretion) at each enrolling institution
PHASE II: Patients must have known estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor  (HER) status defined as triple-negative breast cancer (TNBC), defined as:\r\n* ER and PR =< % by immunohistochemistry, and HER-negative (defined as immunohistochemistry [IHC]  or +, or fluorescent in situ hybridization [FISH] ratio < .)
Non-metastatic, histologically or cytologically-confirmed triple negative breast cancer (TNBC) (defined as estrogen receptor [ER] <%, progesterone receptor [PR] <%, her--neu -+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH]-negative or as per doctor of medicine [MD] discretion).
Patients may have hormone receptor positive or hormone receptor negative HER-negative disease; hormone receptor positivity (estrogen receptor [ER] and/or progesterone receptor [PR]) is defined by at least % of positive tumor cells in the sample by immunohistochemistry (IHC); triple negative is defined by the lack of estrogen and progesterone receptor and by HER-negative status; HER-negative disease can be determined by fluorescent in situ hybridization (FISH) or IHC; negativity by IHC is defined as scores of  or +; borderline IHC results (i.e., +) should undergo FISH testing; subjects with an HER FISH ratio =< . are eligible
Histologically confirmed adenocarcinoma of the breast with the following markers: estrogen receptor negative (< %), progesterone receptor negative (< %), and human epidermal growth factor receptor (Her)-/neu negative (Her-/neu -+ immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] ratio < . or average HER gene copy number of < four signal/nucleus for test systems without internal control probe) or breast adenocarcinoma identified as basal-like subtype on molecular testing
Patients enrolling on the phase II portion of this trial must have estrogen receptor (ER), progesterone receptor (PR) and HER negative disease defined as less than % staining for ER and PR, and HER -+ by immunohistochemistry (IHC), or + by IHC and no evidence of amplification by fluorescence in situ hybridization (FISH) using local laboratory testing
TNBC confirmed by medical history as: human epidermal growth factor receptor  [HER]-negative (confirmed by IHC , + regardless of fluorescence in situ hybridization [FISH] ratio; IHC + with FISH ratio lower than . or HER gene copy less than .; FISH ratio of , 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 % positive tumor nuclei); progesterone receptor negative (confirmed as progesterone receptor expression less than or equal to % positive tumor nuclei)
Patients with ) stage IV metastatic triple negative breast cancer (triple negative is defined as estrogen receptor [ER] and progesterone receptor [PgR] status is < % of tumor cell nuclei are immunoreactive for ER or PgR, and HER status is fluorescence in situ hybridization [FISH] negative or immunohistochemistry [IHC]  or +), or ) stage IV HR+ HER- (HR+) breast cancer (defined as ER or PgR > % of tumor cell nuclei are immunoreactive for ER or PgR and HER status is FISH negative or IHC  or +)
Patients with histologically confirmed invasive breast cancer that is: triple negative (estrogen receptor [ER] < %, progesterone receptor [PR] < %, and human epidermal growth factor receptor  (HER) /+ or +/fluorescence in situ hybridization [FISH] not amplified)
Estrogen receptor (ER) and progesterone receptor negative (a tumor is ER and/or progesterone receptor positive if at least  percent (%) of the cells examined have estrogen and/or progesterone receptors) and human epidermal growth factor receptor  (HER) negative (defined as immunohistochemistry [IHC] less than (<) + or fluorescence in situ hybridization [FISH] negative).
Patients with stage II-III breast cancer that is HER-negative by immunohistochemistry (IHC) (-+) or fluorescence in situ hybridization (FISH) (HER/chromosome enumeration probe [CEP] amplification ratio < .) 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 (=< % by IHC) or PR negative (=< % by IHC)
Histological 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: < % staining by immunohistochemistry (IHC)\r\n* HER-negative disease, defined as IHC -+ or non-amplified fluorescence in situ hybridization (FISH < .)
Invasive breast cancer must be estrogen receptor (ER)/progesterone receptor (PR)-negative (defined as less than % positivity by immunohistochemistry [IHC]), and human epidermal growth factor  (Her)-negative; if breast cancer is Her + by IHC, then fluorescence in situ hybridization (FISH) must be negative for Her gene amplification
Patients must have histologically confirmed operable triple negative breast cancer\r\n* Estrogen receptor (ER) and progesterone receptor (PR) expression must be < %\r\n* HER must negative as shown be either  or + by immunohistochemistry (if +, in situ hybridization method used to define HER) OR by a HER:  centromere signal of < . using a standard in situ hybridization method
Primary 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 < % by immunohistochemistry [IHC]; the invasive tumor must be HER-negative, defined as  or + by IHC or fluorescent in situ hybridization [FISH] < .)
Histologically-confirmed invasive triple negative breast cancer (estrogen receptor [ER] < %, progesterone receptor [PR] < %, human epidermal growth factor receptor  [her--neu] -+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH]-negative) or as determined by Doctor of Medicine (MD) discretion
Patient must have any one of the following types of breast cancer (primary or metastatic): estrogen receptor (ER)+/PgR+/human epidermal growth factor receptor  negative (HER-) or ER+/PgR-/HER-\r\n* ER+ is defined as Allred score of at least  and greater\r\n* PgR+ is defined as Allred score of at least  and greater\r\n* IHC is the primary assay methodology for HER; HER- refers to HER of , + by IHC or negative by fluorescence in situ hybridization (FISH)
Histologically confirmed TNBC (i.e., estrogen receptor [ER] negative, progesterone receptor [PR] negative (each < % staining by immunohistochemistry) and human epidermal growth factor receptor  (Her) negative (-+ or fluorescent in situ hybridization [FISH] nonamplified; by clinical assay on primary tumor)
Patients must have estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor  (HER) non-expressing breast cancer defined as:\r\n* < % of tumor nuclei that are immunoreactive for ER and PR\r\n* Fluorescence in situ hybridization (FISH) ratio of less than . or immunohistochemistry (IHC) staining of  or +