Clinical Trial

A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer

Recruiting Phase 2
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Summary
A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).
Protocol Amendment History 6 changes
notable Trial sites expanded: 45 -> 49 locations 2026-07-14
notable Trial sites expanded: 36 -> 45 locations 2026-06-16
notable Trial sites expanded: 19 -> 36 locations 2026-05-19
notable Trial sites expanded: 10 -> 19 locations 2026-04-21
notable Trial sites expanded: 7 -> 10 locations 2026-04-07
minor Completion moved earlier: 2030-12-30 -> 2030-02-26 2026-04-07
Trial Details
NCT Number NCT07405801
Lead Sponsor Hoffmann-La Roche
Conditions Breast Cancer
Enrollment 80 participants
Start Date 2026-04-07
Primary Completion 2028-12-19 (estimated)
Study Completion 2030-02-26 (estimated)
Updated on ClinicalTrials.gov 2026-07-13