Trial Profile

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 29 May 2025

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At a glance

Drugs Alpelisib (Primary) ; Paclitaxel (Primary)
Indications Advanced breast cancer; Male breast cancer; Triple negative breast cancer
Focus Registrational; Therapeutic Use
Acronyms EPIK-B3
Sponsors Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals

23 May 2025 Planned End Date changed from 2 May 2025 to 5 Sep 2025.
07 Mar 2025 Planned End Date changed from 2 Sep 2024 to 2 May 2025.
12 Sep 2024 This trial has been completed in Austria , according to the European Clinical Trials Database record

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