Table 2 Main results of phase II/III trials testing PARP inhibitors in breast cancer.
Drug(s) | Phase | N | Population enrolled | Design | Primary endpoint | Results | Trial |
|---|---|---|---|---|---|---|---|
Olaparib | III | 302 | Advanced gBRCA, HER2 negative, ≤ 2 prior lines of CT | Olaparib vs TPC | PFS | Median PFS (mo) 7.0 vs 4.2 Median OS (mo) 19.3 vs 17.1 ORR 59.9% vs 28.8% | OlympiAD (NCT02000622) |
Olaparib | II | 102 | Neoadjuvant therapy for HER2 negative BC with gBRCA or tBRCA and/or high HRD score | Olaparib + paclitaxel → AC vs Carboplatin+ paclitaxel → AC | pCR | pCR 55.1% vs 48.6% | GeparOLA (NCT02789332) |
Veliparib | III | 634 | Neoadjuvant therapy for stage II/III TNBC | Carboplatin + paclitaxel + veliparib → AC vs carboplatin+ paclitaxel + placebo →AC vs placebo+placebo + paclitaxel→ AC | pCR | pCR 58% vs 53% vs 31% | BrighTNess (NCT02032277) |
Veliparib | II | 116 | Neoadjuvant therapy for stage II/III TNBC | Carboplatin + paclitaxel + veliparib/placebo → AC | pCR | pCR 51% vs 26% | I-SPY 2 (NCT01042379) |
Veliparib | II | 290 | Advanced gBRCA 0–2 prior lines of CT | Carboplatin+ paclitaxel + veliparib vs carboplatin+ paclitaxel + placebo vs temozolamide + veliparib | PFS | Median PFS (mo) 14.1 vs 12.3 vs 7.4 Median OS (mo) 28.3 vs 25.9 vs 19.1 ORR 77.8% vs 61.3% vs 28.6% | BROCADE (NCT01506609) |
Veliparib | III | 513 | Advanced gBRCA, HER2 negative 0–2 prior lines of CT | Carboplatin + paclitaxel + veliparib vs carboplatin + paclitaxel + placebo | PFS | Median PFS (mo) 14.5 vs 12.6 Median OS (mo) 33.5 vs 28.2 ORR 75.% vs 74.1% | BROCADE3 (NCT02163694) |
Talazoparib | III | 431 | Advanced gBRCA, HER2 negative ≤ 3 prior lines of CT | Talazoparib vs TPC | PFS | Median PFS (mo) 8.6 vs 5.8 Median OS (mo) 22.3 vs 19.5 Response rate 62.6% vs. 27.2% | EMBRACA (NCT01945775) |
Niraparib | III |  | Advanced gBRCA, HER2 negative ≤ 2 prior lines of CT | Niraparib vs TPC | PFS | Ongoing (no results available) | BRAVO (NCT01905592) |
