Trial Profile

A Phase II Randomized Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Chinese Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, PIK3CA Mutant Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor (AI) Treatment, Including a Subset With Pharmacokinetic Analysis

Status: Active, no longer recruiting

Phase of Trial: Phase II

Latest Information Update: 24 Apr 2026

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At a glance

Drugs Alpelisib (Primary) ; Fulvestrant (Primary)
Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
Focus Therapeutic Use
Sponsors Novartis Pharmaceuticals

02 Apr 2026 Planned End Date changed from 2 Mar 2026 to 29 Jan 2027.
02 Apr 2026 Planned primary completion date changed from 2 Mar 2026 to 29 Jan 2027.
16 May 2025 Planned End Date changed from 31 Aug 2025 to 2 Mar 2026.

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