Patients 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)
Newly 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)
The 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)
SAFETY 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)
RANDOMIZED 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)
Histologically 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)
Either 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 used
<1% staining by immunohistochemistry (IHC) for estrogen (ER) and progesterone (PR) receptors, 0 or 1+ IHC for human epidermal growth factor receptor 2 (HER2), OR
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 < 1% by immunohistochemistry (IHC)\r\n* HER2-negative: 0 or 1+ by IHC, or fluorescence in situ hybridization (FISH) < 2.0
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) >= 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+ intensity
Triple-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)
Clinical 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.
Core 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 cancer
Either 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 available
Confirmed 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 < 4
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] < 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)
Histological 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%
Histologically 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 eligible
HER2 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 regimen
New 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])
Patients 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 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 < 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 method
INCLUSION 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])
Patients 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-amplified
Clinical 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 analysis
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 positive (+) by IHC or 2+, fluorescence in situ hybridization (FISH) < 2, gene copy number < 4
Patients 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 patients
Stage 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+
Confirmed 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)
Estrogen receptor negative - defined as less than or equal to 5% staining by immunohistochemistry (IHC)
Progesterone receptor negative - defined as less than or equal to 5% staining by IHC
Histologically 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)
Must 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 cell
Estrogen receptor negative – defined as less than 1% staining by immunohistochemistry (IHC)
TNBC defined as ER and PR negative (<1%) and HER-2 negative (FISH negative or IHC 0-1+)
Patients 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)
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 2 (Her2)-negative by Hercep test (0 or 1+) or not overexpressed by fluorescent in situ hybridization (FISH)
Estrogen receptor (ER) and progesterone receptor (PR) negative; defined as ER =< 10% and PR =< 10% staining by immunohistochemistry (IHC)
PSTAT3 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 status
Histologically 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)
Have 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)
Tumor 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 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 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 contraindicated
Subject 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 < 2.0
Histologically 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 institution
PHASE 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)
Non-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).
Patients 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 eligible
Histologically 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 testing
Clinical 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 allowed
Patients 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 testing
For 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)
TNBC 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)
Patients 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+)
Patients 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)
Estrogen 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).
Patients 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)
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: < 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)
Histologically 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.
Invasive 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 amplification
Pre-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 assay
Patients 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 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 < 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)
The 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)
Histologically-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) discretion
Histologically 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)
Patients 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+