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A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Study acronym: INAVO123
StatusRecruiting
PhasePhase 3
Started2025-04-09
View on ClinicalTrials.gov ↗
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

Amendment history 6 changes detected by DataLookout

2026-09-04
Primary completion moved earlier: 2032-05-30 → 2032-01-31
2026-09-04
Completion moved earlier: 2032-05-30 → 2032-02-01
2026-08-06
Trial sites expanded: 232 → 239 locations
2026-07-03
Trial sites expanded: 227 → 232 locations
2026-05-05
Trial sites expanded: 219 → 226 locations
2026-04-04
Trial sites expanded: 210 → 219 locations
Trial Details
NCT Number NCT06790693
Lead Sponsor Hoffmann-La Roche
Conditions Breast Cancer
Enrollment 450 participants
Start Date 2025-04-09
Primary Completion 2032-01-31 (estimated)
Study Completion 2032-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-03