The tumor must have estrogen receptor (ER)-and progesterone receptor (PgR)-status assessed using current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; patients are eligible if the tumor staining meets one of the following criteria:\r\n* ER-negative and PgR- negative by ASCO/CAP guidelines, OR\r\n* ER or PgR stains are positive in 1-9% of cells and neither is positive in >= 10% of cells
Patients must have metastatic and/or recurrent (distant or locoregionally recurrent) breast cancer and be HER2 non-over expressing per 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) HER testing guidelines (0 or 1+ by immunohistochemistry [IHC]; and/or HER2 ratio < 2.0 and HER2 copy number < 4 signals/cell by in-situ hybridization [ISH])\r\n* Local Regional Recurrence\r\n** In the breast (after preserving therapy)\r\n** In the chest wall (after mastectomy)\r\n** In the ipsilateral/parasternal/infra-or supraclavicular lymph nodes\r\n** In the skin of the chest wall (not breast)\r\n** In the reconstructed breast
Patients must have had estrogen receptor (ER) analysis performed on the primary breast tumor before neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP guideline recommendations for hormone receptor testing
Assessment of HER2 status in patients with breast cancer should follow the 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria (37) as practicable.
Cohort A Dose Escalation (Ribociclib + PDR001): Breast participants:\r\n* Hormone receptor (HR)-positive, HER2-negative metastatic breast cancer according to American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines\r\n* Men are eligible, as long as on a gonadotropin releasing hormone (GNRH) agonist for at least 6 weeks prior to study entry; men MUST remain on the GnRH agonist for the duration of protocol\r\n* Prior Chemotherapy: Participants may have received any number of prior lines of chemotherapy for advanced breast cancer, as long as the last dose is >= 21 days prior to first dose of study treatment.
Histological confirmation of HER2-positive advanced breast cancer; HER2+ is defined by 2013 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
Either the primary tumor and/or the metastasis must have been tested for estrogen receptor (ER), progesterone receptor (PR) and HER2; patient must have HER2+ breast cancer per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines 2013
The primary tumor, and/or metastasis must have been tested for ER, PR and HER 2, and be HER2 positive as defined by the 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines
Breast cancer must be estrogen receptor (ER)-negative, and HER-2 negative according to College of American Pathologists (CAP)/American Society of Clinical Oncology (ASCO) biomarkers testing guidelines; tumors may be progesterone receptor (PgR) positive with an Allred score of less than 5
Histologically or cytologically confirmed invasive breast cancer of the following subtype:\r\n* TRIPLE NEGATIVE (estrogen receptor [ER]-negative, progesterone receptor [PR]-negative, and HER2-negative disease); triple-negative patients will be defined per American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines\r\n* HER2-POSITIVE: HER2-positive patients will be defined per ASCO-CAP guidelines\r\n* HORMONE REFRACTORY: patients with ER/PR-positive disease according to ASCO-CAP guidelines above may be considered if they have disease progression after two lines of hormonal therapy (administered in the adjuvant or metastatic setting), or are deemed clinically hormone-resistant taking into consideration the rate of progression of disease or a short interval of time on first line hormonal therapy before progression; clinically hormone resistant patients MUST also be discussed with the Study Chair, Study co-Chair (Roisin Connolly, MBBCh), or designee in advance for approval\r\n** NOTE: ASCO-CAP guidelines state that ER and PR assays be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls; HER2-positive is defined as HER2 immunohistochemistry (IHC) 3+, in situ hybridization (ISH) >= 2.0, or average HER2 copy number >= 6.0 signals\r\n** NOTE: a patient who has a change in receptor status (e.g. PR negative to positive) may be stratified as triple negative or hormone positive, contrary to the most recent receptor testing, for the purposes of the study, based upon the clinical course at the discretion of the Study Chair, Study co-Chair (Roisin Connolly, MBBCh), or designee in advance for approval
Hormone receptor (HR) status of the invasive component must be documented before trial enrollment; the tumor must be HR-positive; HR will be considered positive if staining is 1% or greater for ER and/or PR; this will be determined at the enrolling institution for purposes of study participation and enrollment onto the trial; subsequently, HR status will be confirmed by central pathology review, but this central review will not be required prior to enrolling the patient; HER2 status will be determined locally only, based upon current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Participant has human epidermal growth factor receptor 2 (HER2) negative breast cancer as defined by American Society of Clinical Oncology (ASCO)-College of American Pathologists guidelines.
Invasive disease must have been tested for estrogen receptor (ER), progesterone receptor (PR) and HER2; participants must have hormone-receptor positive, HER2-negative breast cancer defined as:\r\n* ER > 1% or PR > 1%\r\n* HER2-negative per American Society of Clinical Oncology (ASCO) College of American Pathologist (CAP) guidelines, 2013
Invasive disease must have been tested for estrogen receptor (ER), progesterone receptor (PR), and HER2 and participants must have hormone receptor-positive, HER2-negative breast cancer (ER > 1% or PR > 1%, AND HER2-negative per American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines, 2013)
Histologically confirmed metastatic triple negative breast cancer with measurable disease by RECIST 1.1 criteria hormone receptor (HR) defined as positive for the purposes of this study, if expression of estrogen receptor (ER) and/or progesterone receptor (PR) expression is greater than 10% by immunohistochemistry (IHC) and HER2 negative or non-amplified is determined by the current American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) criteria, which are as follows: HER2 testing by IHC as 0 or 1+. If HER2 is 2+, ISH (in situ hybridization) must be performed.
Histologically confirmed HR+/HER2- (according to American Society of Clinical Oncology/College of American Pathologists guidelines) invasive carcinoma of the breast
Tumor must be estrogen receptor and/or progesterone receptor positive (i.e hormone receptor positive [HR+] and HER-2 negative as defined by the American Society of Clinical Oncology/College of American Pathologists [ASCO-CAP] guidelines: HR+ is defined as expression of ER and/progesterone receptor [PR] in >= 1% of cells, or HR+ by local laboratory or regional definition; HER2? is defined as a HER2 immunohistochemistry [IHC] score of 0 or 1+, or an IHC score of 2+ accompanied by a negative fluorescence, chromogenic, or silver in situ hybridization test indicating the absence of HER2 gene amplification, or a HER2/CEP17 ratio of < 2.0, or local clinical guidelines
Estrogen-receptor and progesterone-receptor expression both < 10% by immunohistochemistry (IHC) and HER2 negative by IHC or non-amplified as determined by the current American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) criteria; if patient has more than one histological result, the most recent one has to be considered for inclusion
Subjects who enroll in the triple-negative breast cancer (TNBC) dose expansion cohort should adhere to the American Society for Clinical Pathology (ASCP)/College of American Pathologists (CAP) guidelines for the definition of TNBC.
Have diagnosis of triple negative breast cancer (defined as estrogen receptor [ER] < 1% by immunohistochemistry [IHC], progesterone receptor [PR] < 1% by IHC, Her 2 negative by  American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines)
Patients must have either:\r\n*Hormone receptor (HR) negative and HER-2 negative (TNBC) metastatic breast cancer and have not received prior chemotherapy for metastatic disease and should have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line); demonstrated HER-2 negative MBC (0 or 1+ by immunohistochemistry [IHC] or non-amplified by fluorescence in situ hybridization [FISH]) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAPA) guidelines; Or\r\n* Histologically or cytologically confirmed estrogen receptor (ER) positive and HER-2 negative metastatic breast cancer are eligible if they have progressed on single agent or combination endocrine therapy (e.g. AI/palbociclib or everolimus) indicating an endocrine-refractory disease
Qualifying risk status, at diagnosis utilizing receptor testing by American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, meeting one of the following:\r\n* Histologically positive axillary lymph nodes\r\n* Primary tumor that is estrogen receptor (ER)/progesterone receptor (PR)/Her2 negative\r\n* Primary tumor that is ER+/Her2 negative/lymph node negative with Breast Cancer Recurrence Score of >= 25 per the Genomic Health Oncotype diagnosis (DX) breast cancer test\r\n* Evidence of residual disease in the breast on pathological assessment after neoadjuvant chemotherapy
Patients must have histologically confirmed hormone receptor positive (ER and/or progesterone receptor [PR]), human epidermal growth factor receptor 2 (HER2) negative, early invasive breast cancer; ER, PR and HER2 measurements should be performed according to institutional guidelines, in a Clinical Laboratory Improvement Amendments (CLIA)-approved setting in the United States (US) or certified laboratories for non-US regions; cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines; central confirmation is not required for ER, PR, or HER statuses
Most recent tumor biopsy or surgical resection specimen must be either estrogen receptor (ER) positive, progesterone receptor (PgR) positive, or both, as defined by immunohistochemistry (IHC) >= 1% (as per the American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)
Express at least 1 of the hormone receptors [HR; estrogen receptor (ER) or progesterone receptor (PR)] by immunohistochemistry (IHC) to fulfill the requirement for HR+ disease on the primary tumor or metastatic lesion of the breast cancer. ER and PR assays are considered positive if there is at least 1% positive tumor nuclei in their sample as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) or local guidelines.
Have histologically confirmed adenocarcinoma of the breast that is either TNBC or HR positive/HER-2 negative; TNBC is defined as: estrogen receptor (ER)/progesterone receptor (PR) < 1% and HER-2 negative disease (Immunohistochemistry [IHC] 0-1+ or 2+ with HER2/17 ratio on Fluorescence In Situ Hybridization [FISH] =< 1.8) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; HR positive is defined as: ER/PR >= 1% and HER-2 negative as per ASCO/CAP guidelines
Documentation of the following receptors based on local testing from most recent assessment:\r\n* ER-positive and/or PR-positive tumor (>= 1% positive stained cells)\r\n* HER2-negative tumor; NOTE: HER2-negative is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (FISH/CISH/SISH) defined as a HER2/CEP17 ratio < 2, for single probe assessment a HER2 copy number < 6 or per current American Society Clinical Oncologists (ASCO)-College of American Pathologists (CAP) or National Comprehensive Cancer Network (NCCN) guidelines
Breast cancer determined to be HER2-negative per current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) HER2 Guidelines\r\n* Note: Eligibility should be based on the HER2 status reported at the time of the most recent biopsy or resection
Histologically confirmed metastatic or recurrent triple-negative (i.e. estrogen receptor =< 5%, progesterone receptor =< 5%, HER2-negative via immunohistochemistry [IHC] or fluorescent in situ hybridization [FISH] per American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guidelines 2013) breast cancer
Breast cancer must be determined by local testing to be human epidermal growth factor receptor 2 (HER2)-positive prior to study entry using American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) HER2 test guidelines.
Has documented HER2 negative expression according to American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelines
A diagnosis of invasive breast cancer, with or without an in situ component, that is: \r\n* Originally identified by screening mammography \r\n* Characterized by standard diagnostic mammography +/- breast ultrasound\r\n* Clinically node negative \r\n* Confirmed by breast magnetic resonance imaging (MRI) in a facility that maintains active American College of Radiology (ACR) accreditation to be of low clinical stage (=< 2 cm, node negative, unifocal invasive)\r\n* Estrogen receptor (ER) and progesterone receptor (PR) Allred scored, each > 5/8\r\n* Her2 negative using American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines\r\n* ki?67 proliferation scored, < 20%\r\n* Clinical Nottingham grade 1 or 2\r\n* Scored on the MammaPrint 70-gene breast cancer recurrence assay as low risk
No evidence of ischemic heart disease based on 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines
Newly diagnosed histologically confirmed stage I-III, estrogen receptor (ER), progesterone receptor (PR) and HER2 negative invasive breast cancer as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard National Comprehensive Cancer Network (NCCN) practice guidelines (Theriault et al, 2013)
Must be HER2-positive in primary breast tumor or lymph node by the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2013
Histologically confirmed breast cancer that overexpresses HER2 (defined by American Society of Clinical Oncology [ASCO]- College of American Pathologists [CAP] 2013 guidelines performed using Food and Drug Administration [FDA]-approved tests by laboratories with demonstrated proficiency) that is metastatic or unresectable
The subject must have histologically or cytologically confirmed metastatic estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+) and human epidermal growth factor receptor 2 (HER2) negative breast cancer; (stains may be performed on either primary or metastatic tumor samples, ER and PR assays will be considered positive if there are at least 1% positive tumor nuclei in the sample as per American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guidelines, HER2 negative as per ASCO/CAP guidelines)
Histologically confirmed TNBC, defined as negative immunohistochemical staining for estrogen and progesterone receptors (=< 5% of nuclei positive by immunohistochemistry [IHC]) and human epidermal growth factor receptor 2 (HER2) negative (IHC 0-1+ or HER2-neu negative according to American Society of Clinical Oncology and the College of American Pathologists [ASCO-CAP] guideline)
The tumor must have been determined to be estrogen receptor (ER) and/or progesterone (PgR) positive assessed by current American Society of Clinical Oncology (ASCO)/College of American Pathologist (CAP) guideline recommendations for hormone receptor testing; patients with >= 1% ER or PgR staining by IHC are considered positive
HER2/neu negative disease (performed on primary tumor and/or metastatic lesion using commercially available/approved assay in local institutional or reference laboratory), according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Human epidermal growth factor receptor 2 (HER2) negative as per American Society of Clinical Oncology/College of American Pathologists guidelines.
Subjects must meet at least one of the following two criteria:\r\n* Histologically proven TNBC defined as estrogen receptor (ER) immunohistochemistry (IHC) =< 10%, progesterone receptor (PgR) IHC =< 10% and human epidermal growth factor receptor (HER)-2 negative disease per 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) HER testing guidelines (0 or 1+ by IHC; and/or HER2 ratio < 2.0 and HER2 copy number < 4 signals/cell by fluorescence in situ hybridization [FISH])\r\n* Confirmed germline BRCA1 or BRCA2 mutation associated breast cancer regardless of the subtype of breast cancer
Estrogen-receptor and progesterone-receptor expression both =< 1% by immunohistochemistry (IHC), and HER2-negative status as determined by the current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines; if a patient has more than one histological result, the most recent sample will be considered for inclusion
HER2 negative disease as per 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, one of the following must apply:\r\n* 0 or 1+ by immunohistochemistry (IHC) and not amplified by in situ hybridization (ISH)\r\n* 0 or 1+ by IHC and ISH not done\r\n* 2+ by IHC and not amplified by ISH or\r\n* IHC not done and not amplified by ISH
Histologically proven diagnosis of TNBC per current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline;\r\n* Estrogen receptor (ER) negative (ER expression =< 1% positive tumor nuclei), progesterone receptor (PR) negative (PR expression =< 1% positive tumor nuclei) and HER2 negative breast cancer by IHC and /or fluorescence in situ hybridization (FISH)
Newly diagnosed (cohort 2) stage IV metastatic ER+HER2- breast cancer histologically proven per current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; allow up to 30 days prior use of endocrine therapy +/- CDK4/6 inhibitors for treatment of metastatic ER+ breast cancer
HER2 positivity as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Patients who are Human epidermal growth factor 2 +(HER2+) as defined by American Society of Clinical Oncology and College of American Pathologists (ASCO CAP) guidelines must have failed all prior therapy known to confer clinical benefit
Operable ER-positive/HER2- negative, invasive early breast cancer, suitable for neoadjuvant AI treatment. HER2-negative as determined by American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelines.
HER2-positive as determined using ASCO-CAP Guidelines.
Participants must have documented HER2+ disease by overexpression and/or gene amplification on the most recent biopsy, per current ASCO-CAP (American Society of Clinical Oncology – College of American Pathologists) 2013 guidelines; central confirmation of HER2 status is not required
Participants must have histologically confirmed hormone receptor positive (HR+) HER2 negative metastatic or locally recurrent unresectable invasive breast cancer; both measurable and non-measurable disease are allowed; ER, progesterone receptor (PR) and HER2 measurements should be performed according to institutional guidelines, in a Clinical Laboratory Improvement Act (CLIA)-approved setting; cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines
Subjects must have a histologically confirmed diagnosis of hormone receptor (HR)+/HER2+ positive locally advanced unresectable or metastatic breast cancer; estrogen or progesterone receptor positivity is defined by immunohistochemistry (IHC) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2010; HER2 positivity is defined by standard of care fluorescence in situ hybridization (FISH) and/or 3+ staining by IHC according to ASCO/CAP guidelines 2014
Has newly diagnosed, locally advanced, centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
Erythropoietin stimulating agents (ESA) and blood transfusions are allowed as medically indicated, ESA use should be consistent with American Society of Clinical Oncology (ASCO) guidelines
Patients must have HER2-positive breast cancer as defined by ASCO/CAP 2013 guidelines that is confirmed by a Sponsor-designated central laboratory
Assessment of HER2 status in subjects with breast cancer should follow the 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria (Wolff et al, 2013) as practicable.
HER2 positive by 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines (immunohistochemistry [IHC] 3+ and/or fluorescence in situ hybridization [FISH] positive; IHC 2+ HER2 patients are eligible with reflex FISH positive testing with the ratio >= 2.0) breast cancer patients with untreated asymptomatic or minimally symptomatic brain metastasis by MRI; there is no upper or lower limit to the size or number of brain metastases
Participants must have HR positive, HER2-negative breast cancer (estrogen receptor [ER] > 1% and/or, progesterone receptor [PR] > 1%, HER2-negative per American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines, 2013 resulted on the primary tumor and/or a metastatic lesion)
Dose expansion: patients must have histologically or cytologically confirmed invasive adenocarcinoma of the breast (human epidermal growth factor receptor 2 [HER2]-negative) that is locally advanced/metastatic and has progressed despite standard therapy; at least 1 prior chemotherapy regimen in the metastatic setting, and two lines of hormonal therapy (administered in the adjuvant or metastatic setting) for patients with hormone receptor-positive disease; NOTE: HER2-negativity will be defined per American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines; patients whose tumors have HER2 immunohistochemistry (IHC) 3+, in situ hybridization (ISH) >= 2.0, or average HER2 copy number >= 6.0 signals per cell are not eligible
Human epidermal growth factor receptor- 2 (HER- 2) negativity will be based on the current American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines for HER testing
Normal Pap or Atypical Squamous Cells of Undetermined Significance (ASCUS) Pap test with HPV deoxyribonucleic acid (DNA) negative by reflex testing via Hybrid Capture 2 (Digene Corp., Gaithersburg, MD), a standard clinical assay within clinically acceptable screening guidelines (American Cancer Society [ACS]/American Society for Colposcopy and Cervical Pathology [ASCCP] 2012 Screening Guidelines)
Up to date with all age appropriate cancer screening tests, as per American Cancer Society guidelines
HER2 negative disease based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER2 status.
Participants must have biopsy proven localized estrogen receptor (ER) positive (+) (>= 10%), HER2 negative, any grade, invasive breast adenocarcinoma, with pathological stage (including post-neoadjuvant therapy) T1c-T4c, any N, M0, by American Joint Committee on Cancer (AJCC) seventh (7th) edition staging; invasive breast cancer must be ER+ in >= 10% of the cells and HER2 negative (immunohistochemistry [IHC] 0 or 1+ and/or fluorescence in situ hybridization [FISH] negative with a ratio < 2) by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; for IHC 2+, the tumor must be FISH negative with a ratio < 2; progesterone receptor (PR) status must be performed; ER, PR and HER2 measurements should be performed according to institutional (local) guidelines, in a Clinical Laboratory Improvement Act (CLIA)-approved setting; evaluation for metastatic disease is not required in the absence of symptoms; patients must have completed definitive surgery for breast cancer
Patients must have had ER analysis performed on the primary breast tumor collected prior to neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing
Histologically proven infiltrating carcinoma of the breast on core needle biopsy that is:\r\n* ER/progesterone receptor (PR) =< 10% staining by immunohistochemistry (IHC)\r\n* HER2 positive – IHC 3+, in situ hybridization (ISH) >= 2.0, or average HER2 copy number >= 6.0 signals per cell or per current ASCO-CAP (American Society of Clinical Oncology – College of American Pathologists) or NCCN (National Comprehensive Cancer Network) guidelines\r\n* Note: All histological diagnostic material should be reviewed at enrolling institution as required per local standards
Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/college of American Pathologists (ASCO/CAP) guidelines.
Histologically proven diagnosis of breast cancer with evidence of metastatic disease or locoregional recurrence. 3. Histological confirmation and documentation of estrogen receptor (ER)-positive status (?1% positive stained cells). 4. Histological or cytological confirmation and documentation of human epidermal growth factor receptor-2 (HER2)-negative status by local laboratory testing using criteria in the American Society of Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline update.
American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
American Society of Anesthesiologists physical status (ASA) 1-3.
American Society of Anesthesiologists (ASA) class 4 or greater
Poor general health (ASA class>3)
ASA score 1-3.
ASA class 4 or 5
ASA score 1-2.
American Society of Anesthesiologists (ASA) criteria of IV or higher
Subject with American Society of Anesthesiology (ASA) status higher than 3.
ASA status > 2
ASA score (American Society of Anesthesiologists) ? 4
Subject has ASA classification of 5;
American Society of Anesthesiologists (ASA) criteria of IV or higher;
American Society of Anesthesiologists (ASA) score </= 3;
Favorable operative risk defined as American Society of Anesthesiology Score (ASA score) =< 3
American Society of Anesthesiologists (ASA) status > 3
Classified by the American Society of Anesthesiologists (ASA) as class I - IV
American Society of Anesthesiology (ASA) physical status I-III
ASA IV-V
American Society of Anesthesiologists (ASA) I-III
American Society of Anesthesiologists Status > III, assigned at time of pre operative visit
American Society of Anesthesiologists (ASA) physical status 4 or 5
American Society of Anesthesiologists (ASA) score of > or = 3
American Society of Anesthesiologists (ASA) < 4
ASA status > 2
ASA class > 3