3상모집 중단 (진행 중)
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.
연구 개요
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.
- 스폰서
- 리드: 노바티스
- 적응증
- Breast Cancer
- 중재
- Alpelisib, Fulvestrant, Alpelisib-matching placebo
- 목표 등록
- 210명
- 시작일
- 2021-12-17
- 완료(예정)
- 2027-02-26
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