{"entity":{"id":"nct03330847","kind":"trial","name":"To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.","aka":["VIOLETTE"],"tldr":"A phase 2 trial of Olaparib and Ceralasertib in triple-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy. is a phase 2 interventional study registered as NCT03330847 by AstraZeneca, with 273 participants enrolled, started 2018-03-07 and due to reach its primary completion in 2020-11-13. Interventions recorded: Olaparib Continuous (28-Day cycle) 300 mg BD., Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle). and Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03330847","url":"https://clinicaltrials.gov/study/NCT03330847"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["olaparib","ceralasertib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03330847-clin-cancer-res-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03330847","phase":"2","setting":"A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-Related Genes (Including BRCA1/2) (VIOLETTE).","sponsor":"AstraZeneca","started":"2018-03-07","startedType":"actual","yearReported":2022,"enrolled":273,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (Per BICR), All patients per BICR","unit":"months","arms":[{"name":"Olaparib Monotherapy","n":114,"value":3.6,"note":"90% CI 2.9 to 5.4; Figures from the ClinicalTrials.gov results section (first posted 2022-03-22), not from a publication"},{"name":"Olaparib + Ceralasertib","n":112,"value":5.3,"note":"90% CI 3.7 to 5.5"},{"name":"Olaparib + Adavosertib","n":47,"value":3.8,"note":"90% CI 3.7 to 5.6"}],"source":"https://clinicaltrials.gov/study/NCT03330847?tab=results"},{"endpoint":"Number of Patients With Objective Response (Per BICR and Per Sensitivity Analysis), All patients per BICR","unit":"participants","arms":[{"name":"Olaparib Monotherapy","n":114,"value":24,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-03-22), not from a publication"},{"name":"Olaparib + Ceralasertib","n":112,"value":32},{"name":"Olaparib + Adavosertib","n":47,"value":9}],"source":"https://clinicaltrials.gov/study/NCT03330847?tab=results"}]},"route":"/trials/nct03330847/","neighbours":{"cancer":[{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"parp-inhibitor","kind":"technology","name":"PARP inhibitors","route":"/technologies/parp-inhibitor/"}],"drug":[{"id":"adavosertib","kind":"drug","name":"Adavosertib","route":"/drugs/adavosertib/"},{"id":"ceralasertib","kind":"drug","name":"Ceralasertib","route":"/drugs/ceralasertib/"},{"id":"olaparib","kind":"drug","name":"Olaparib","route":"/drugs/olaparib/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"paper":[{"id":"paper-nct03330847-clin-cancer-res-2026","kind":"paper","name":"Safety and Efficacy of Ceralasertib plus Olaparib for Advanced/Metastatic Triple-Negative Breast Cancer in Three Molecular Strata: The Phase II VIOLETTE Study","route":"/key-papers/paper-nct03330847-clin-cancer-res-2026/"}]}}