Gender | Breast Carcinoma | Age
Item
female breast cancer patient > 18 years.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Invasive carcinoma of breast TNM Breast tumor staging
Item
patients must have biopsy-proven clinical stage ic-iii invasive breast carcinoma with
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Estrogen Receptor Expression Percentage Immunohistochemistry
Item
≤ 10% er expression by immunohistochemistry (ihc) analysis.
boolean
C0034804 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0021044 (UMLS CUI [1,4])
Pre treatment Core needle biopsy | Pre treatment Incisional biopsy | Estrogen Receptor Protein Expression Analysis | Estrogen Receptor Gene Expression Level Analysis
Item
patients must have a pre-treatment baseline core biopsy or incisional biopsy available for additional testing (er, protein/gene expression analysis).
boolean
C2709094 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C2709094 (UMLS CUI [2,1])
C0184922 (UMLS CUI [2,2])
C0034804 (UMLS CUI [3,1])
C1882495 (UMLS CUI [3,2])
C0034804 (UMLS CUI [4,1])
C4521390 (UMLS CUI [4,2])
Tumor tissue sample Remaining Sufficient | Status post Biopsy | Requirement Operative Surgical Procedure Standard of Care | Indication Segmental Mastectomy | Indication Mastectomy
Item
patients must have sufficient tumor remaining following diagnostic biopsy that requires an additional definitive surgical procedure per the standard of care. planned procedure may include lumpectomy or mastectomy as clinically indicated.
boolean
C0475358 (UMLS CUI [1,1])
C1527428 (UMLS CUI [1,2])
C0205410 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C2936643 (UMLS CUI [3,3])
C3146298 (UMLS CUI [4,1])
C0024885 (UMLS CUI [4,2])
C3146298 (UMLS CUI [5,1])
C0024881 (UMLS CUI [5,2])
ECOG performance status
Item
patients must have an ecog performance status of 0 - 1.
boolean
C1520224 (UMLS CUI [1])
Informed Consent English Language | Informed Consent Spanish Language
Item
patients must have the ability to understand and willingness to sign an english or a spanish language written informed consent document.
boolean
C0021430 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Gender | Breast Carcinoma
Item
male breast cancer patient.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods | Females & males of reproductive potential Sexual Abstinence
Item
patients who are pregnant or breast-feeding are excluded from the study due to potential harm to the fetus or nursing infant from the study therapy. patients of reproductive potential must consent to use of contraception or abstinence to be eligible for the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C4034483 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma
Item
patients may not have received prior chemotherapy or hormonal therapy for treatment of the current breast cancer.
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
BRCA gene Mutation | BRCA gene Mutation Suspected
Item
patients should not have known or strongly suspected brca mutation by history (genetic testing not required).
boolean
C0596223 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
C0596223 (UMLS CUI [2,1])
C0026882 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
Requirement Pre-study Testing | Requirement Medical History | Requirement Physical Examination | Requirement Complete Blood Count | Requirement Measurement of renal function | Requirement Liver Function Tests | Patient Abnormality Ineligible
Item
patients will have pre-study testing, including history and physical exam, complete blood count, and measurement of renal and hepatic function. patients will be ineligible for the study if significant abnormalities are detected, in accordance with good medical practice.
boolean
C1514873 (UMLS CUI [1,1])
C1527048 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0009555 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C2711919 (UMLS CUI [5,2])
C1514873 (UMLS CUI [6,1])
C0023901 (UMLS CUI [6,2])
C0030705 (UMLS CUI [7,1])
C1704258 (UMLS CUI [7,2])
C1512714 (UMLS CUI [7,3])