Adding olaparib to this neoadjuvant chemotherapy schedule did not improve response or survival in germline-BRCA-wild-type TNBC.
The registry lists NCT03150576 as recruiting, last updated 2022-11-14. Enrolment is 780 planned participants, an estimate. Interventions: Olaparib, Paclitaxel and Carboplatin. Primary measures include Stage 1 - Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03.; Stage 2 - pCR rate and completion rate of Olaparib treatment as per protocol.. No results are posted in the registry; this does not exclude separate publications. The 2024 germline-BRCA-wild-type randomised cohort included 559 participants. Pathological complete response was 51% versus 52% (p=0.753); three-year event-free survival was 80% versus 79% (p>0.9), and overall survival was 90% versus 87.2% (p=0.8). The separate 2025 germline-BRCA-positive cohort reported no pCR improvement (64.1% versus 69.8%, p=0.59), but estimated three-year EFS of 96.4% versus 80.1% and OS of 100% versus 88.2% (both p=0.04). The authors state that the result needs confirmation in larger trials. This is not a positive result in the wild-type population.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Jean Abraham, Germline BRCA mutation (gBRCA), BRCA1 / BRCA2 (HRD), Platinum agents and the tags uk, breast.
Shares Jean Abraham, BRCA1 / BRCA2 (HRD), Triple-negative breast cancer (TNBC) and the tags uk, breast.
Shares Pathologic complete response (pCR), PARP inhibitors, PARP, Olaparib and the tag breast.
Shares Triple-negative breast cancer (TNBC) and the tags uk, breast.
Shares BrighTNess, Germline BRCA mutation (gBRCA), PARP inhibitors, PARP.
Shares KEYNOTE-522, Pathologic complete response (pCR), Olaparib, Early triple-negative breast cancer and the tag breast.
Shares PARP inhibitors, Olaparib, Early triple-negative breast cancer, Triple-negative breast cancer trials open today (registry snapshot and UK sites).
Shares KEYNOTE-522, Pathologic complete response (pCR), PARP, BRCA1 / BRCA2 (HRD) and the tag breast.
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