Clinical Trial

A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

Recruiting Phase 2
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Summary
This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).
Protocol Amendment History 3 changes
minor Trial arms changed: 3 -> 4 2026-06-24
notable Trial sites expanded: 30 -> 33 locations 2026-06-24
notable Trial sites expanded: 27 -> 30 locations 2026-04-28
Trial Details
NCT Number NCT07054190
Lead Sponsor Hoffmann-La Roche
Conditions Breast Cancer
Enrollment 60 participants
Start Date 2025-09-09
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-09-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-16