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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

Name: 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 — clinical trial record (NCT05894239)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: INAVO122

StatusRecruiting

PhasePhase 3

SponsorHoffmann-La Roche

Started2023-09-08

View on ClinicalTrials.gov ↗

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).

Amendment history 2 changes detected by DataLookout

2026-04-01

Trial sites expanded: 187 → 190 locations

2026-04-01

Primary completion pushed: 2026-09-28 → 2026-12-31

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	2026-08-25