Clinical Trial

A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

Study acronym: reaINAVO
Recruiting
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Summary
The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.
Protocol Amendment History 3 changes
notable Trial sites expanded: 23 -> 28 locations 2026-07-11
notable Trial sites expanded: 17 -> 22 locations 2026-05-19
notable Trial sites expanded: 9 -> 17 locations 2026-04-21
Trial Details
NCT Number NCT07347600
Lead Sponsor Hoffmann-La Roche
Conditions Locally Advanced Breast Cancer, Metastatic Breast Cancer
Enrollment 500 participants
Start Date 2026-01-21
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-09-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-10