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Olaparib showed activity in metastatic breast cancer with germline PALB2 or somatic BRCA alterations, but the somatic cohort missed its prespecified response target.
The registry lists NCT03344965 as active not recruiting, last updated 2026-01-05. Enrolment is 114 planned participants, an estimate. Interventions: Olaparib. Primary measures include Objective Response Rate. No results are posted in the registry; this does not exclude separate publications. The 2026 expansion publication reports 54 participants: 24 germline PALB2 and 30 somatic BRCA1/2, with 42 ER-positive/HER2-negative, seven TNBC and five HER2-positive cancers. Germline PALB2 response was 75% (80% CI 60.2-86.3), median PFS 9.4 months (90% CI 8.3-13.1). Somatic BRCA response was 36.7% (80% CI 24.7-50.0), median PFS 5.5 months (90% CI 2.8-8.3), and failed the prespecified response target. This metastatic single-arm evidence does not establish an adjuvant somatic-BRCA indication.
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.
80% CI 60.2-86.3; single-arm cohort, predominantly ER-positive breast cancer across the trial
Source80% CI 24.7-50.0; prespecified response target not achieved
SourceShares 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).
Shares PARP, Breast cancer (all types).
Shares PARP, Breast cancer (all types).
Shares PARP, Breast cancer (all types).
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