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)

AC doxorubicin + cyclophosphamide, CT, chemotherapy, gBRCA germline BRCA mutation, HRD score Homologous Recombinant Deficiency score, iDFS invasive disease free survival, mo months, ORR objective response rate, pCR pathological complete response, PFS progression-free survival, OS overall survival, tBRCA somatic BRCA mutation, TPC treatment of physician’s choice chemotherapy.