Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

Phase 3 Active not recruiting 210 enrolled Novartis Pharmaceuticals

RandomizedCrossoverTriple-blindTreatment

Summary

The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI plus a CDK4/6 inhibitor.

Timeline

Start: 2021-12-17
Primary completion: 2027-01-28
Completion: 2027-02-26

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alpelisib	Small molecule	300 mg	Oral
Background	Fulvestrant	Small molecule	500 mg	Intramuscular

Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

Summary

Timeline

Drugs

Indications