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A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

Name: A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy — clinical trial record (NCT05646862)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: INAVO121

StatusRecruiting

PhasePhase 3

SponsorHoffmann-La Roche

Started2023-06-07

View on ClinicalTrials.gov ↗

This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.

Amendment history 3 changes detected by DataLookout

2026-09-02

Enrollment reopened

2026-09-02

Trial sites expanded: 145 → 210 locations

2026-05-07

Primary completion pushed: 2026-04-06 → 2026-11-13

Trial Details

NCT Number	NCT05646862
Lead Sponsor	Hoffmann-La Roche
Conditions	Breast Cancer
Enrollment	420 participants
Start Date	2023-06-07
Primary Completion	2026-11-13 (estimated)
Study Completion	2029-03-30 (estimated)
Updated on ClinicalTrials.gov	2026-09-01