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Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 18, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
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 (NCT04208178). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 19 participants (ACTUAL). Conditions: Advanced HER2+Breast Cancer. Interventions: DRUG: Alpelisib; DRUG: Alpelisib matching Placebo; DRUG: Trastuzumab; DRUG: Pertuzumab. Primary outcome measures: Part 1: Incidence of dose limiting toxicities (DLTs) for each dose level , 6 weeks; Part 2: Progression Free Survival (PFS) , Up to approximately 38 months. Brief summary: The purpose of this two part multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA mutation following induction therapy with a taxane in combination with trastuzumab and pertuzumab. Part 1 is the open-label, safety run-in part of the study, designed to confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab. Following Part 1, Part 2 will be initiated, which is the randomized, Phase III part of the study.