Triple Negative Breast Neoplasm Androgen Receptor Positive Invasive TNM Breast tumor staging | Neoadjuvant Chemotherapy | Anthracycline | taxane | Residual disease Breast | Status post Excision | Lumpectomy | Mastectomy | Androgen Receptor Testing
Item
participants with a histologically or pathologically confirmed diagnosis of triple negative, ar positive invasive breast carcinoma (stage ii or iii) who have received neoadjuvant chemotherapy (anthracycline or taxane or both) who have residual disease in their breasts following surgical resection by lumpectomy or mastectomy; androgen receptor (ar) testing will be performed on all patients who have residual invasive breast cancer after neoadjuvant taxane and/or anthracycline for triple negative breast cancer; this will be done under institutional protocol approval; physicians of patients who have ar positive tumors will be notified by our research coordinator of the potential eligibility for this study
boolean
C3539878 (UMLS CUI [1,1])
C2986463 (UMLS CUI [1,2])
C0205281 (UMLS CUI [1,3])
C0474926 (UMLS CUI [1,4])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0282564 (UMLS CUI [3])
C0215136 (UMLS CUI [4])
C0543478 (UMLS CUI [5,1])
C0006141 (UMLS CUI [5,2])
C0231290 (UMLS CUI [6,1])
C0728940 (UMLS CUI [6,2])
C0851238 (UMLS CUI [7])
C0024881 (UMLS CUI [8])
C0034786 (UMLS CUI [9,1])
C0039593 (UMLS CUI [9,2])
Operative Surgical Procedure | Negative Surgical Margins Breast Carcinoma | Residual disease Invasive Breast | Residual disease Invasive Lymph nodes | Neoplasm Metastasis Absent | Therapeutic radiology procedure Completed
Item
participants must have undergone definitive surgery with negative margins for breast cancer in the past 2 years and must have residual pathologic invasive disease in the primary breast or lymph nodes or both; at the time of protocol entry it will be determined under good medical practice that there is no evidence for metastatic disease; patients should have completed all radiation therapy if indicated at the time of study entry
boolean
C0543467 (UMLS CUI [1])
C1709157 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0543478 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
C0006141 (UMLS CUI [3,3])
C0543478 (UMLS CUI [4,1])
C0205281 (UMLS CUI [4,2])
C0024204 (UMLS CUI [4,3])
C0027627 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C0205197 (UMLS CUI [6,2])
Zubrod Performance Status
Item
patients must have a zubrod performance status of 0-2
boolean
C3714786 (UMLS CUI [1])
Serum specimen Submission | Whole blood sample Submission
Item
patients must consent to the serum and whole blood specimen submissions
boolean
C1550100 (UMLS CUI [1,1])
C1515022 (UMLS CUI [1,2])
C0444256 (UMLS CUI [2,1])
C1515022 (UMLS CUI [2,2])
Able to swallow Oral medication | Nausea Uncontrolled Excluded | Vomiting Excluded | Diarrhea Excluded | Lack Integrity Upper gastrointestinal tract Excluded | Malabsorption Syndrome Excluded
Item
patients must be able to take oral medications (patients with uncontrolled nausea, vomiting, diarrhea at baseline, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, are excluded)
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0027497 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0042963 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0011991 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0332268 (UMLS CUI [5,1])
C1947912 (UMLS CUI [5,2])
C1268997 (UMLS CUI [5,3])
C0332196 (UMLS CUI [5,4])
C0024523 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents; women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of this trial
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Informed Consent
Item
patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
boolean
C0021430 (UMLS CUI [1])
Granulocyte count
Item
granulocyte count > 1,500/mcl
boolean
C0857490 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 100,000/mcl
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin =< 3 x institutional upper limit of normal (iuln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
aspartate aminotransferase (ast)/alanine aminotransferase (alt) =< 5 x iuln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine =< 1.5 x iuln
boolean
C0201976 (UMLS CUI [1])
Communicable Disease Requirement Systemic therapy
Item
patients must not have a current active infection requiring systemic therapy
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Cardiac event | Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral artery bypass | Symptomatic congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism
Item
patients must not have had a cardiac event within 6 months prior to registration such as myocardial infarction (including severe/unstable angina), coronary/peripheral artery bypass graft, symptomatic congestive heart failure (chf), cerebrovascular accident or transient ischemic attack, or pulmonary embolism
boolean
C0741923 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C3495795 (UMLS CUI [6])
C0742758 (UMLS CUI [7])
C0038454 (UMLS CUI [8])
C0007787 (UMLS CUI [9])
C0034065 (UMLS CUI [10])