PARPi Clinical Trial (ClinicalTrial.gov no.) Design Setting Patient population Primary outcome measure Total patients (n) Intervention Key results
Olaparib OlympiAD (NCT02000622)[@253755] Olaparib vs PCT (double-blind RCT) Advanced/Metastatic Advanced/Metastatic gBRCA HER2-, ≤2 prior lines Investigator-assessed PFS 302 Olaparib (n=205), PCT (n=97) Median PFS was 7.0 months in the olaparib group vs 4.2 months in the PCT group (HR: 0.58 [95% CI: 0.43−0.80]; p<0.001)
OlympiA
(NCT02032823)[@253712]
Olaparib vs placebo (double-blind RCT) Adjuvant Early-stage gBRCA HER2-, post-completion SoC adjuvant therapy IDFS 1836 Olaparib (n=921), placebo (n=915) At a median follow-up of 2.5 years, the 3-year IDFS was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 % points [95% CI: 4.5−13.0]; HR: 0.58 [99.5% CI: 0.41−0.82; p<0.001)
PARTNER
(NCT03150576)
C+P+Olaparib (open-label, single-arm) Neoadjuvant TNBC and/or gBRCA pCR rates at surgery after neoadjuvant chemotherapy +/- olaparib Recruiting (no results available)
LUCY
(NCT03286842)[@253756]
Olaparib (open-label, single arm) Metastatic Metastatic, gBRCA HER2-, ≤2 prior lines Investigator-assessed PFS in a real-world setting (interim analysis after 160 PFS events) 252 Olaparib (n=252) At the interim analysis, the median PFS was 8.11 months (95% CI: 6.93−8.67; 166/252 events; 65.9% maturity)
Talazoparib EMBRACA
(NCT01945775)[@253757]
Talazoparib vs PCT (double-blind, RCT) Advanced/Metastatic Advanced/Metastatic gBRCA, ≤3 prior lines Investigator-assessed PFS 431 Talazoparib group (n=287), PCT (capecitabine, eribulin, gemcitabine, or vinorelbine) group (n=144) Median PFS was 8.6 months in the talazoparib group vs 5.6 months in the PCT group (HR: 0.54 [95% CI 0.41−0.71]; p<0.001)
Niraparib BRAVO
(NCT01905592)[@253758]
Niraparib vs PCT (double-blind RCT) Advanced/Metastatic Advanced/Metastatic gBRCA HER2-, ≤2 prior lines Investigator-assessed PFS 206 ITT Niraparib (n=141), PCT (n=74) At a median follow-up of 19.9 months, median PFS was 4.1 months in the niraparib vs 3.1 months in the PCT group (HR: 0.96 [95% CI: 0.65−1.44]; p=0.86)
ZEST
(NCT04915755)
Niraparib vs placebo (double-blind RCT) Stage I to III (Early to Advanced) BRCA-mutated HER2- (independent of hormone receptor status, including hormone receptor-positive and TNBC); and BRCA-wildtype TNBC DFS Recruiting (no results available)
Veliparib BROCADE 3
(NCT02163694)
C+P+V vs C+P+ placebo (double-blind RCT) Advanced/Metastatic Metastatic gBRCA HER2-, 0─2 prior lines Investigator-assessed PFS per RECIST (v 1.1) 509 ITT Veliparib group (n=337), placebo group (n=172) Median PFS was 14.5 months (95% CI: 12.5–17.7) in the veliparib group vs 12.6 months (95% CI: 10.6–14.4) in the control group (HR: 0.71 [95% CI: 0.57–0.88]; p=0.0016)
BrighTNess
(NCT02032277)[@253759; @253760]
PCV vs PC+placebo vs P+placebo+placebo; plus AC (double-blind, RCT) Neoadjuvant Neoadjuvant TNBC gBRCA pCR in breast and lymph nodes 634 PCV (n=316), PC (n=160) and P (n=158) pCR in the PCV group vs P alone (53% vs 31%; p<0.0001) vs PC (58%; p=0.36).[@253759] At a median follow-up of 4.5 years, HR for EFS with PCV vs P was 0.63 (95% CI: 0.43‒0.92, p=0.016) and 1.12 (95% CI: 0.72‒1.72; p=0.620) for PCV vs PC.[@253760]