{"preliminary_commentary":{"by_channel":{"x_thread":2,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"NCT03330847","nct_id":"NCT03330847","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03330847. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"All randomized patients will receive Olaparib monotherapy 300 mg twice daily (BD).","label":"Olaparib monotherapy","type":"ACTIVE_COMPARATOR"},{"description":"All randomized patients will receive Olaparib 300 mg twice daily+Ceralasertib 160 mg once daily (OD).","label":"Olaparib+Ceralasertib","type":"ACTIVE_COMPARATOR"},{"description":"All randomized patients will receive Olaparib 200 mg BD +adavosertib 150 mg BD. Following the discontinuation of adavosertib+olaparib treatment arm on 18 April 2019, patients receiving treatment with adavosertib+olaparib treatment were offered the opportunity to continue treatment on olaparib monotherapy at the approved dose (300 mg bd).","label":"Olaparib+adavosertib","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2026-10-09","type":"ESTIMATED"},"conditions":["Metastatic Triple Negative Breast Cancer"],"enrollment":{"count":273,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Olaparib Continuous (28-Day cycle) 300 mg BD.","otherNames":[],"type":"DRUG"},{"name":"Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle).","otherNames":[],"type":"DRUG"},{"name":"Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-14","lead_sponsor":"AstraZeneca","official_title":"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).","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2020-11-13","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival Per Stratum (BICR)","timeFrame":"Until date of first documented progression or censoring date or date of death from any cause, whichever came first (assessed up to 32 months)"},{"measure":"Progression-free Survival Per Stratum (Sensitivity Analysis)","timeFrame":"Until date of first documented progression or censoring date or date of death from any cause, whichever came first (assessed up to 32 months)"}],"references":[{"citation":"Smith G, Alholm Z, Coleman RL, Monk BJ. DNA Damage Repair Inhibitors-Combination Therapies. Cancer J. 2021 Nov-Dec 01;27(6):501-505. doi: 10.1097/PPO.0000000000000561.","pmid":"34904813","type":"DERIVED"}],"start_date":{"date":"2018-03-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.","url":"https://clinicaltrials.gov/study/NCT03330847"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03330847"}