<% staining by immunohistochemistry (IHC) for estrogen (ER) and progesterone (PR) receptors, or + IHC for human epidermal growth factor receptor (HER), OR
Cohort patient must have HER-/HR+ stage III IBC; HER negative status, which determined by assays using IHC require negative ( or +) staining score; if IHC is equivocal (+) staining score, assays using FISH require the absence of gene amplification: dual-probe HER/CEP ratio is < . and an average HER copy number < . signals/cell; if HER 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) >= % and /or progesterone receptor (PR) >= % by IHC staining
Estrogen receptor negative - defined as less than or equal to % staining by immunohistochemistry (IHC)
Progesterone receptor negative - defined as less than or equal to % staining by IHC
Estrogen receptor negative defined as less than % staining by immunohistochemistry (IHC)
Completely 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 > % positive tumor cells with nuclear staining), and negative for HER as defined by one of the four situations delineated below: \r\n* HER immunohistochemistry (IHC) expression of or + and in-situ hybridization non-amplified\r\n* HER IHC expression of or + and in-situ hybridization not done\r\n* HER IHC expression of + and in-situ hybridization non-amplified\r\n* IHC not done and in-situ hybridization non-amplified\r\n* Note: central review is not required
Tumors must stain positive for estrogen receptor (>= %) by immunohistochemistry (IHC)
Clinical stage IV invasive mammary carcinoma, estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive by immunohistochemistry (IHC); patients with HER fluorescence in-situ hybridization (FISH) ratio < (IHC + is acceptable) will be enrolled in the ER+ / HER-non-amplified cohort of patients; patients with HER FISH ratio >= will be enrolled in the ER+ / HER-amplified cohort of patients; patients may have either measurable or non-measurable disease, both are allowed
Patients must have tumors that demonstrate ER/PR+ (positivity by immunohistochemistry [IHC] staining >= %)
For TNBC Subjects: Have histologically or cytologically confirmed diagnosis of metastatic (Stage IV) TNBC, and irrespective of PD-L status. TNBC is defined as negative immunohistochemistry (IHC) assays for Estrogen Receptor (ER), and Progesterone Receptor (PR), and HER negative (IHC or +, or + by IHC confirmed negative by FISH)
Diagnosis of TNBC: < % cells positive for ER/progesterone receptor, and HER IHC score of or , or FISH HER+ ratio of less than .; patients with low ER IHC (> % but < % cells positive), but negative by genomic assay are eligible
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 (HER)-negative (HER =< by IHC; if HER + by IHC must be fluorescence in situ hybridization [FISH] non-amplified)\r\n* Recurrence score >= using Oncotype DX -gene assay
The patient was proven to have TNBC, defined from standard pathologic assays as negative for ER and PR (< % tumor staining) and negative for HER (immunohistochemistry [IHC] score < , gene copy number not amplified)
Histologically confirmed advanced solid tumors with HR-positivity defined as > % on immunohistochemistry (estrogen receptor-positive with or without positivity for the progesterone receptor) and HER/neu positivity (+ on IHC and/or + on IHC and FISH amplified, or by v-erb-b avian erythroblastic leukemia viral oncogene homolog [ERBB] mutation on next generation sequencing)
The patient has proven TNBC, defined by standard pathologic assays as negative for estrogen receptor (ER) and progesterone receptor (PR) (< % tumor staining) and negative for human epidermal growth factor (HER) (immunohistochemistry [IHC] score < , gene copy number not amplified)