Table 2.
Summary of phase II/III trials of PARP inhibitors discussed in this review.
| SMI | Trial | Phase | Patient population | Treatment | Outcomes |
|---|---|---|---|---|---|
| Olaparib | NCT0049423470 | II | BRCA1/2 mutations and advanced breast cancer. Cohort 1 (MTD), n = 27; Cohort 2 (low dose), n = 27 | Single agent olaparib | Cohort 1: ORR 41%; Cohort 2: ORR 22% |
|
NCT02000622 (OlympiAD)71 |
III | Germline BRCA mutation and HER2-negative MBC (n = 302) | Olaparib / standard therapy (capecitabine, eribulin or vinorelbine) | PFS: 7.0 months versus 4.2 months ORR: 59.9% versus 28.8% |
|
| Veliparib | NCT0150660975 | II | BRCA1/2-mutated breast cancer (n = 290) | Veliparib + carboplatin/paclitaxel (VCP)/veliparib + temozolomide (VT) and placebo + carboplatin/paclitaxel (PCP) | VCP (PFS: 14.1 months; OS: 28.3 months; ORR:
77.8%) VT (PFS 7.4 months; OS 19.1 months; ORR 28.6%) PCP (PFS: 12.3 months; OS: 25.9 months, ORR: 61.3%) |
| NCT0130603255 | II | Refractory TNBC (n = 39) | Veliparib + cyclophosphamide/cyclophosphamide | PR: two patients versus one patient PFS: 2.1 months versus 1.9 months |
|
| NCT02032277 (BrighTNess)76 | III | Stage II–III TNBC (n = 634) | Paclitaxel + carboplatin + veliparib/paclitaxel alone | pCR: 53% versus 31% | |
| Talazoparib |
NCT02034916 (ABRAZO)80 |
II | Advanced or MBC and gBRCA1/2-mutation (n = 84) | Talazoparib (platinum-based therapy)/talazopaib (platinum-free cytotoxic-based regimens) | ORR: 21% versus 37% DOR: 5.8 months versus 3.8 months CBR: 38% versus 66% PFS: 4.0 months versus 5.6 months |
|
NCT01945775 (EMBRACA)81 |
III | Advanced breast cancer and a gBRCA1/2-mutation (n = 431) | Talazoparib/physician’s choice | PFS: 8.6 months versus 5.6 months OS: 22.3 months versus 19.5 months ORR: 62.6% versus 27.2% CBR: 68.6% versus 36.1% |
CBR, clinical benefit rate; DOR, duration of response; HER2, human epidermal growth factor 2; MBC, metastatic breast cancer; MTD, maximum tolerated dose; NCT, ClinicalTrials.gov identifier; ORR, objective response rate; OS, overall survival; PARP, poly (adenosine diphosphate-ribose) polymerase; PCP, placebo plus carboplatin/paclitaxel; pCR, pathological complete response; PFS, progress-free survival; PR, partial response; TNBC, triple-negative breast cancer.