3상모집 중단 (진행 중)
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
연구 개요
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.
- 스폰서
- 리드: 로슈
- 적응증
- Breast Cancer
- 중재
- Inavolisib, Fulvestrant, Alpelisib, Bupropion, Omeprazole, Midazolam
- 목표 등록
- 420명
- 시작일
- 2023-06-07
- 완료(예정)
- 2029-03-30
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