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EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

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Trial Profile

EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Jul 2025

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At a glance

  • Drugs Alpelisib (Primary) ; Pertuzumab (Primary) ; Trastuzumab (Primary)
  • Indications Advanced breast cancer; HER2 positive breast cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms EPIK-B2
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 02 Jul 2025 Planned End Date changed from 15 Dec 2025 to 16 Jun 2026.
  • 02 Jul 2025 Planned primary completion date changed from 15 Dec 2025 to 16 Jun 2026.
  • 20 Sep 2024 Planned End Date changed from 16 Dec 2024 to 15 Dec 2025.

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