- 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 — Active Not Recruiting • Phase III….
- New cancer drug inavolisib plus fulvestrant compared with alpelisib plus fulvestrant for advanced breast cancer resistant to previous treatments.
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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. Conditions: Breast Cancer Interventions: Inavolisib, Fulvestrant, Alpelisib, Bupropion, Omeprazole, Midazolam Lead Sponsor: Hoffmann-La Roche Planned Enrollment: 420 participants