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Replacing chemotherapy with olaparib alongside pembrolizumab did not improve the primary progression-free survival outcome in metastatic TNBC.
The registry lists NCT04191135 as terminated, last updated 2026-09-14. Enrolment is 462 actual participants. Interventions: Pembrolizumab, Olaparib, Carboplatin, Gemcitabine. Primary measures include Progression-Free Survival (PFS); Overall Survival (OS). The registry reason for stopping is: Business Reasons Results are posted in the registry. The primary paper reports 460 participants receiving induction and 271 randomised; these analysis populations differ from the registry total of 462. Median PFS was 5.5 versus 5.6 months (HR 0.98, 95% CI 0.72-1.33, p=0.4556), and OS 25.1 versus 23.4 months (HR 0.95, 95% CI 0.64-1.40). Exploratory tumour-BRCA subgroup estimates were imprecise and do not establish a positive subgroup trial.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
462 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival, randomised maintenance populationprimary | Pembrolizumab plus olaparib | - | 5.5 months | 0.98 (0.72 to 1.33) | 0.4556 | link |
| Pembrolizumab plus chemotherapy | - | 5.6 months | ||||
| Overall survival, randomised maintenance population | Pembrolizumab plus olaparib | - | 25.1 months | 0.95 (0.64 to 1.4) | - | link |
| Pembrolizumab plus chemotherapy | - | 23.4 months |
Shares PARP, Olaparib, Breast cancer (all types).
Shares PARP, Olaparib, Breast cancer (all types).
Shares PARP, Breast cancer (all types).
Shares PARP, Breast cancer (all types).
Shares PARP, Breast cancer (all types), Triple-negative breast cancer (TNBC).
Shares PARP, Olaparib, Triple-negative breast cancer (TNBC).
Shares PARP, Breast cancer (all types).
Shares Olaparib, Breast cancer (all types), Triple-negative breast cancer (TNBC).
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/