Clinical Trial

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

Study acronym: optINAVO
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
Protocol Amendment History 4 changes
notable Trial sites expanded: 26 -> 30 locations 2026-07-08
notable Primary completion moved earlier: 2031-10-31 -> 2028-10-31 2026-07-08
notable Trial sites expanded: 19 -> 26 locations 2026-06-10
notable Trial sites expanded: 16 -> 19 locations 2026-05-12
Trial Details
NCT Number NCT07368998
Lead Sponsor Hoffmann-La Roche
Conditions Breast Cancer
Enrollment 80 participants
Start Date 2026-02-18
Primary Completion 2028-10-31 (estimated)
Study Completion 2031-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-06