Clinical Trial

Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

Study acronym: EPIK-B2
Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 37 amendments
This ClinicalTrials.gov record has been amended 37 times since 2019-12-19; most recent amendment 2026-06-10.
Status change: Recruiting → Active, Not Recruiting 2023-09-05
Status change: Active, Not Recruiting → Recruiting 2023-03-30
Status change: Recruiting → Active, Not Recruiting 2022-12-16
Status change: Not Yet Recruiting → Recruiting 2020-06-25
Trial Details
NCT Number NCT04208178
Lead Sponsor Novartis Pharmaceuticals
Conditions Advanced HER2+Breast Cancer
Enrollment 19 participants
Start Date 2020-07-16
Primary Completion 2027-02-26 (estimated)
Study Completion 2027-02-26 (estimated)
Updated on ClinicalTrials.gov 2026-06-11