Breast adenocarcinoma Invasive Triple Negative Primary | Triple Negative Breast Neoplasm Invasive
Item
histologically confirmed non-metastatic primary triple negative invasive adenocarcinoma of the breast. •invasive triple negative breast cancer
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0205174 (UMLS CUI [1,3])
C1513916 (UMLS CUI [1,4])
C0205225 (UMLS CUI [1,5])
C3539878 (UMLS CUI [2,1])
C0205281 (UMLS CUI [2,2])
Deleterious BRCA1 Gene Mutation predicted | Deleterious BRCA2 Gene Mutation predicted | Deleterious BRCA1 Gene Mutation Suspected | Deleterious BRCA2 Gene Mutation Suspected
Item
documented mutation in brca1 or brca2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
boolean
C4289700 (UMLS CUI [1,1])
C0681842 (UMLS CUI [1,2])
C4287905 (UMLS CUI [2,1])
C0681842 (UMLS CUI [2,2])
C4289700 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C4287905 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Operation on breast Completed | Operative Surgical Procedure Axillary Completed
Item
completed adequate breast and axilla surgery.
boolean
C3714726 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0004454 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Anthracyclines | taxane | Combined Modality Therapy | Platinum | Curative treatment Malignant Neoplasms | Curative treatment Ovarian Carcinoma | Adjuvant therapy Breast Carcinoma | Neoadjuvant Therapy Breast Carcinoma
Item
completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both. prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed.
boolean
C0282564 (UMLS CUI [1])
C0215136 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0032207 (UMLS CUI [4])
C1273390 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C1273390 (UMLS CUI [6,1])
C0029925 (UMLS CUI [6,2])
C0677850 (UMLS CUI [7,1])
C0678222 (UMLS CUI [7,2])
C0600558 (UMLS CUI [8,1])
C0678222 (UMLS CUI [8,2])
ECOG performance status
Item
ecog 0-1.
boolean
C1520224 (UMLS CUI [1])
PARP Inhibitors | olaparib | Hypersensitivity Investigational New Drugs Pharmaceutical Excipient
Item
any previous treatment with a parp inhibitor, including olaparib and/or known hypersensitivity to any of the excipients of study treatment.
boolean
C1882413 (UMLS CUI [1])
C2316164 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
Second Primary Cancers | Exception Skin carcinoma Treated | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment DCIS | Exception Curative treatment Endometrial cancer Stage Grade | Exception Curative treatment Solid Neoplasm | Exception Curative treatment Lymphoma Without Bone Marrow Involvement | Exception Disease Free of Duration | Chemotherapy cycle Quantity Malignant Neoplasms
Item
patients with second primary cancer, exceptions: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (dcis) of the breast, stage 1 grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥ 5 years prior to randomization. more than one course of chemotherapy for previous malignancies.
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0007124 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0280255 (UMLS CUI [5,3])
C0441800 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
C0280100 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1273390 (UMLS CUI [7,2])
C0024299 (UMLS CUI [7,3])
C0332288 (UMLS CUI [7,4])
C1517677 (UMLS CUI [7,5])
C1705847 (UMLS CUI [8,1])
C0012634 (UMLS CUI [8,2])
C0332296 (UMLS CUI [8,3])
C0449238 (UMLS CUI [8,4])
C1302181 (UMLS CUI [9,1])
C1265611 (UMLS CUI [9,2])
C0006826 (UMLS CUI [9,3])
Prolonged QTc ECG Resting | Family history of long QT syndrome
Item
resting ecg with qtc > 470 msec detected on 2 or more time points within a 24 hour period or family history of long qt syndrome. if ecg demonstrates qtc >470 msec, patient will be eligible only if repeat ecg demonstrates qtc ≤470 msec.
boolean
C1969409 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0035253 (UMLS CUI [1,3])
C3839836 (UMLS CUI [2])
CYP3A4 Inhibitors | Ketoconazole | Itraconazole | Ritonavir | Indinavir | Saquinavir | telithromycin | Clarithromycin | Nelfinavir
Item
concomitant use of known potent cyp3a4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
boolean
C3850053 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
C0064113 (UMLS CUI [3])
C0292818 (UMLS CUI [4])
C0376637 (UMLS CUI [5])
C0286738 (UMLS CUI [6])
C0907410 (UMLS CUI [7])
C0055856 (UMLS CUI [8])
C0525005 (UMLS CUI [9])
Whole blood transfusion | Interference Germline BRCA Testing
Item
whole blood transfusions in the last 120 days prior to entry to the study which may interfere with gbrca testing
boolean
C0199961 (UMLS CUI [1])
C0521102 (UMLS CUI [2,1])
C3845275 (UMLS CUI [2,2])
C0596223 (UMLS CUI [2,3])
C0039593 (UMLS CUI [2,4])