{"entity":{"id":"nct03344965","kind":"trial","name":"Olaparib In Metastatic Breast Cancer","aka":[],"tldr":"Olaparib showed activity in metastatic breast cancer with germline PALB2 or somatic BRCA alterations, but the somatic cohort missed its prespecified response target.","summary":"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.","status":"active","asOf":"2026-10-06","links":[{"label":"ClinicalTrials.gov NCT03344965","url":"https://clinicaltrials.gov/study/NCT03344965"},{"label":"TBCRC 048 expansion, 2026","url":"https://doi.org/10.1200/JCO-25-02075"}],"tags":[],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":["parp"],"drugs":["olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03344965","phase":"2","setting":"A Phase 2 Study of Olaparib Monotherapy in Metastatic Breast Cancer Patients With Germline or Somatic Mutations in DNA Repair Genes (Olaparib Expanded)","sponsor":"Beth Israel Deaconess Medical Center","started":"2018-04-01","startedType":"actual","enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response, germline PALB2 cohort (2026 expansion)","unit":"%","arms":[{"name":"Olaparib, germline PALB2","n":24,"value":75,"note":"80% CI 60.2-86.3; single-arm cohort, predominantly ER-positive breast cancer across the trial"}],"source":"https://doi.org/10.1200/JCO-25-02075"},{"endpoint":"Objective response, somatic BRCA1/2 cohort (2026 expansion)","unit":"%","arms":[{"name":"Olaparib, somatic BRCA1/2","n":30,"value":36.7,"note":"80% CI 24.7-50.0; prespecified response target not achieved"}],"source":"https://doi.org/10.1200/JCO-25-02075"}]},"route":"/trials/nct03344965/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"target":[{"id":"parp","kind":"target","name":"PARP","route":"/targets/parp/"}],"drug":[{"id":"olaparib","kind":"drug","name":"Olaparib","route":"/drugs/olaparib/"}]}}