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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 14, 2026
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Phase 2 Trial.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT03330847). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 273 participants (ACTUAL). Conditions: Metastatic Triple Negative Breast Cancer. Interventions: DRUG: Olaparib Continuous (28-Day cycle) 300 mg BD.; DRUG: Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle).; DRUG: Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).. Primary outcome measures: Progression-free Survival Per Stratum (BICR) , Until date of first documented progression or censoring date or date of death from any cause, whichever came first (assessed up to 32 months); Progression-free Survival Per Stratum (Sensitivity Analysis) , Until date of first documented progression or censoring date or date of death from any cause, whichever came first (assessed up to 32 months). Brief summary: This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib \[AZD6738\]) and olaparib monotherapy versus olaparib in combination with an inhibitor of WEE1 (adavosertib \[AZD1775\]) in second or third line setting in patients with Triple-negative breast cancer (TNBC) prospectively stratified by presence/absence of qualifying tumour mutation in genes involved in the homologous recombination repair (HRR) pathway. Treatment arms are olaparib monotherapy, olaparib+ Ceralasertib and olaparib+adavosertib. The study subject population will be divided into Stratum A, Stratum B, and Stratum C. Due to the different schedules of administration of each of the treatment options as well as their different toxicity profiles, the study is not blinded. Study has two stage consent process- stage 1 consent (molecular screening for HRR defects) and stage 2 consent (main study). Patients with TNBC and with known qualifying BRCAm, non BRCAm HRRm and non HRRm status will be offered the option of consenting to the main part of the study within the 28-day screening period. Following the ISRC meeting on 17 April 2019 a recommendation was made to close the adavosertib+olaparib treatment arm across all biomarker strata. Patients receiving treatment with adavosertib+olaparib treatment were offered the opportunity to continue treatment on olaparib monotherapy at the approved dose (300 mg bd). Following the closure of this arm the total number of patients randomised will be lower (approximately 350 patients). Approximately 300 patients will be randomised (using randomisation ratio 1:1) to 2 ongoing treatment arms plus an additional 47 patients to a 3rd arm (olaparib+adavosertib) prior to the arm being discontinued.