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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 26, 2026
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Phase 3 Trial.
No findings were extractable from the material analysed.
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 (NCT05646862). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 420 participants (ESTIMATED). Conditions: Breast Cancer. Interventions: DRUG: Inavolisib; DRUG: Fulvestrant; DRUG: Alpelisib; DRUG: Bupropion; DRUG: Omeprazole; DRUG: Midazolam. Primary outcome measures: Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS) , From randomization until disease progression or death due to any cause (up to approximately 64 months); Sub-study: Maximum observed Drug Concentration (Cmax) for Midazolam , Day -4 and -3 of Cycle (C) 1, Day (D) 11 and C1D12. A cycle is 28 days.; Sub-study: Cmax for Bupropion , Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.; Sub-study: Cmax for Omeprazole , Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.; Sub-study: Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC [0-last]) for Midazolam , Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.; Sub-study: AUC (0-last) for Bupropion , Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.; Sub-study: AUC (0-last) for Omeprazole , Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.; Sub-study: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) for Midazolam , Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.; Sub-study: AUC (0-infinity) for Bupropion , Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.; Sub-study: AUC (0-infinity) for Omeprazole , Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.. Brief summary: This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.