Table 4.
Trials Focused Primarily in Breast Cancer with Brca Mutation | |||||
Study Name/NCT Identifier | Drug(s)/Novel Agent(s) | Study Phase | N | Primary Endpoint | Disease Setting |
EMBRACA Study NCT01945775 |
Talazoparib vs. Physician’s Choice | III | 429 | PFS | Metastatic breast cancer patients with BRCA mutation |
2014-0045 NCT02282345 |
Talazoparib | II | 20 | Toxicity, safety | Neoadjuvant, +BRCA mutation |
Trials in Breast (with or without BRCA Mutation) and other Malignancies | |||||
Study Name/NCT Identifier | Drug(s)/Novel Agent(s) | Study Phase | N | Primary Endpoint | Disease Setting |
OlympiA NCT02032823 |
Olaparib | III | 1320 | DFS | Adjuvant, TNBC in high risk BRCA 1/2 |
ComPAKT NCT02338622 |
Olaparib + AKT inhibitor (AZD5363) | I | 58 | Safety, tolerability | Advanced solid tumors, BRCA 1/2 mutation, TNBC or hyperactive PI3K-AKT pathway |
Abbreviations: NCT = National Clinical Trials, DFS = disease free survival; N = number of patients; PFS = progression free survival; TNBC = triple negative breast cancer, AKT = abbreviation for proto-oncogene also known as protein kinase B or PKB, PI3K-AKT = phosphoinositide 3-kinase/AKT signaling pathway PI3K.