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 >= % 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 Cohort E only: Patients must have histologically confirmed HER+ (IHC + and/or FISH positive [HER/CEP >= and/or > HER gene copies per nucleus]) and hormone receptor positive (estrogen receptor [ER]+ and/or progesterone receptor [PR]+ >= %), metastatic breast cancer
Metastatic breast cancer with any evidence of estrogen receptor (ER) or progesterone receptor (PR) positivity in >= % cells in biopsy specimens from either a primary or metastatic site is eligible
Participants 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 % tumor cell nuclei staining positive for either ER or progesterone receptor (PR)
Patients must have histologically confirmed clinical stage II or III estrogen receptor negative (ER-) progesterone receptor (PR) - HER positive (+) (per College of Pathologists [CAP] criteria) invasive ductal carcinoma of the breast
Estrogen receptor (ER) and progesterone receptor (PR) < Allred score of or =< % positive staining cells in the invasive component of the tumor (provided the patient is being treated as triple negative breast cancer)
Histologically-proven metastatic or locally-advanced relapsed/refractory HER+ 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.
Any estrogen receptor (ER), progesterone receptor (PR), HER status
Estrogen receptor (ER) and progesterone receptor (PR) less than Allred score of or less than % positive staining cells in the invasive component of the tumor
Has positive estrogen receptor (ER) or progesterone receptor (PR) status. ER or PR >= %.
Breast cancer determined to be hormone receptor-positive or hormone receptor-negative defined as follows:\r\n* Hormone receptor-positive: >= % staining by IHC for either estrogen receptor (ER) or progesterone receptor (PgR)\r\n* Hormone receptor-negative: < % staining by IHC for both ER and PgR
Primary, invasive, estrogen receptor (ER) and/or progesterone receptor (PR)-positive, HER negative breast cancer; ER-and/or PRpositive breast cancer is defined by > % staining by immunohistochemistry
Estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor (? % 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 < % 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
Documentation of estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor (>= % 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 standards
Estrogen receptor (ER) and progesterone receptor (PR) less than Allred score of or less than % positive staining cells in the invasive component of the tumor
Estrogen receptor (ER) and progesterone receptor (PR) less than Allred score of or less than % 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 HER/neu status documented by core needle biopsy of the primary tumor and/or regional lymph node must be known prior to beginning systemic therapy
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)
The tumor specimen obtained at the time of diagnosis used for HER testing must also have central testing for estrogen receptor (ER) and progesterone receptor (PgR) according to current ASCO/CAP guideline; patients with < % ER and PgR staining by IHC will be classified as negative
Patient has disease that is hormone-receptor positive (estrogen receptor [ER] and/or progesterone receptor [PR] positive [+], HER-/neu negative [-]) or triple-negative (ER/PR/HER-/neu -).
Known 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 >= % 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)
Estrogen receptor (ER) and progesterone receptor (PR) negative; defined as ER =< % and PR =< % staining by immunohistochemistry (IHC)
Estrogen receptor (ER) and progesterone receptor (PgR) status by IHC must be known; tumor must be ER and PR negative (=< % staining) by local review
Histologically and/or cytologically confirmed diagnosis of ER+ and/or progesterone receptor positive (PR+) breast cancer by local laboratory
Estrogen (ER) and/or progesterone (PR)-positive at primary diagnosis and at metastatic diagnosis where tissue is available (defined as > or = % of staining nuclei)
National 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 HER 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]- 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 HER/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 HER/neu negative
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 A pre-registration biopsy, by institutional/local pathologist of either locally advanced or metastatic breast cancer that is estrogen receptor positive and HER negative; those patients with bone only disease with either no tumor or insufficient tumor for ER/progesterone receptor (PR) and HER staining after the bone biopsy are still eligible to participate in this study
All positive or negative ER (estrogen receptor), PR (progesterone receptor), and HER- 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 HER status)
Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] th edition): eligible participants must have either: Node-positive disease (pN more than or equal to [>/=] ), any tumor size except T, and any hormonal receptor status; or Node-negative disease (pN) with pathologic tumor size >. centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory
Patients must have histologically or cytologically confirmed metastatic invasive breast cancer that is negative for the estrogen receptor (ER), progesterone receptor (PR) and HER by institutional guidelines
Patients have positive estrogen receptor (ER) expression in the primary tumor site by immunohistochemistry (IHC) (defined as >= %) (progesterone receptor [PR] status is not required)
ER/progesterone receptor (PR) determination is required; ER- and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocol
Confirmed pathologic diagnosis of triple negative breast cancer (TNBC), OR estrogen receptor (ER) positive with immunohistochemistry (IHC) staining of -%, irrespective of progesterone receptor (PR) staining, and human epidermal growth factor receptor (HER) negative, OR prior diagnosis of ER positive (>= %) (HER negative) breast cancer that is demonstrated to be ER < % on the patients 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 eligible
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
Patients 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 prostate
Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor [ER] and progesterone receptor [PR]) status and HER- status
Histologically confirmed adenocarcinoma of the breast, with sufficient tissue available for estrogen receptor (ER), progesterone receptor (PR), and HER testing\r\n* HER must be positive by immunohistochemistry (IHC) or in situ hybridization (ISH) testing by laboratory standard.
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] < %, progesterone receptor [PR] <%, and Her-/neu negative)\r\n* Phase I (closed): Negative Her-/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)
If receiving neoadjuvant chemotherapy, must not be triple negative (estrogen receptor [ER]-/progesterone receptor [PR]-/HER-)
Must have BOTH estrogen receptor (ER) and progesterone receptor (PR)-positive tumors and BOTH must be >= % positive; alternatively, if ER and PR are determined by Allred score, the score needs to be 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 (M)
The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor (ER) and progesterone receptor (PgR) staining present in =< % 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
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
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 TcN to TN, estrogen receptor (ER) or progesterone receptor (PR) positive with tumors greater than cm without lymph node spread
Tumors must be estrogen and/or progesterone receptor positive according to ASCO/CAP guidelines as either ER or PR ? % positive nuclear staining by immunohistochemistry based on local laboratory results.