drugset / Trial / NCT07368998

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

NCT07368998

Phase 2 Recruiting 80 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.

Timeline

Start
2026-02-18
Primary completion
2028-10-31
Completion
2031-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Inavolisib Small molecule Oral
Background Fulvestrant Small molecule Intramuscular

Indications