Clinical Trial

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Study acronym: INAVO122
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
Protocol Amendment History 2 changes
notable Trial sites expanded: 187 -> 190 locations 2026-04-01
notable Primary completion pushed: 2026-09-28 -> 2026-12-31 2026-04-01
Trial Details
NCT Number NCT05894239
Lead Sponsor Hoffmann-La Roche
Conditions Metastatic Breast Cancer
Enrollment 230 participants
Start Date 2023-09-08
Primary Completion 2026-12-31 (estimated)
Study Completion 2032-12-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-29