Invasive carcinoma of breast Core needle biopsy | Invasive carcinoma of breast Incisional biopsy | Tumor tissue sample Micron Section
Item
histologic documentation of invasive breast cancer by core needle or incisional biopsy. excess baseline biopsy tumor tissue sufficient to make three 5-micron sections must be available for molecular analyses as part of this study.
boolean
C0853879 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0184922 (UMLS CUI [2,2])
C0475358 (UMLS CUI [3,1])
C0439201 (UMLS CUI [3,2])
C0700320 (UMLS CUI [3,3])
Invasive carcinoma of breast Estrogen Receptor alpha Positive | Estrogen Receptor Staining Method | Invasive carcinoma of breast Immunohistochemistry
Item
the invasive cancer must be estrogen receptor alpha (er)-positive, with er staining present in greater than 50% staining of invasive cancer cells by ihc.
boolean
C0853879 (UMLS CUI [1,1])
C0665341 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C4055053 (UMLS CUI [2])
C0853879 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
Invasive carcinoma of breast HER2 Negative Immunohistochemistry | Invasive carcinoma of breast HER2 Negative FISH
Item
the invasive cancer must be her2 (human epidermal growth factor receptor 2) negative (ihc 0-1+, or with a fish ratio of <1.8 if ihc is 2+ or if ihc has not been done).
boolean
C0853879 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0853879 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
Invasive carcinoma of breast TNM Breast tumor staging | Intent Excision Primary tumor | Tumor size
Item
clinical stage i-iii invasive breast cancer with the intent to treat with surgical resection of the primary tumor. tumor must be ≥ 2cm to provide adequate tissue.
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1283828 (UMLS CUI [2,1])
C0728940 (UMLS CUI [2,2])
C0677930 (UMLS CUI [2,3])
C0475440 (UMLS CUI [3])
Disease Multicentric | Bilateral Disease | Target Lesion Eligibility criteria Fulfill | Tumor tissue sample Requested Research
Item
patients with multi-centric or bilateral disease are eligible if the target lesions meet the other eligibility criteria. samples from all available tumors are requested for research purposes.
boolean
C0012634 (UMLS CUI [1,1])
C0439743 (UMLS CUI [1,2])
C1511113 (UMLS CUI [2])
C2986546 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
C1550543 (UMLS CUI [3,3])
C0475358 (UMLS CUI [4,1])
C1272683 (UMLS CUI [4,2])
C0035168 (UMLS CUI [4,3])
Gender | Age | Indication Aromatase Inhibitors Adjuvant therapy | Postmenopausal state | Premenopausal state Associated with Ovariectomy
Item
women ≥ age 18, for whom adjuvant treatment with an aromatase inhibitor would be clinically indicated. women must be either post-menopausal, or pre-menopausal having undergone oophorectomy.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C0593802 (UMLS CUI [3,2])
C0677850 (UMLS CUI [3,3])
C0232970 (UMLS CUI [4])
C0232969 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0029936 (UMLS CUI [5,3])
Laboratory Criteria Fulfill
Item
patients must meet the following clinical laboratory criteria:
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement
Item
absolute neutrophil count (anc)≥ 1000/mm3 and platelet count ≥ 75,000/mm3. total bilirubin
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
≤ 1.5 x the upper limit of normal range (uln). alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 3 x uln.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Informed Consent
Item
ability to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Hormone Therapy Malignant Neoplasms
Item
prior endocrine therapy for any histologically confirmed cancer is not allowed. prior endocrine therapy that was administered ≥ 5 years ago for the prevention of breast cancer in patients with no history of breast cancer is allowed.
boolean
C0279025 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Pharmacotherapy Systemic Inducing Ovarian suppression | Relationship Premenopausal state
Item
systemic drug treatment to induce ovarian suppression if woman is pre-menopausal.
boolean
C0013216 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205263 (UMLS CUI [1,3])
C0677922 (UMLS CUI [1,4])
C0439849 (UMLS CUI [2,1])
C0232969 (UMLS CUI [2,2])
Neoadjuvant Therapy Breast Carcinoma | Antineoplastic Agents | Exception Letrozole
Item
any other neoadjuvant therapy for breast cancer (i.e., treatment with any other anti-cancer agent besides letrozole (10-21)days before surgical resection of the primary tumor).
boolean
C0600558 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0003392 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0246421 (UMLS CUI [3,2])