drugset / Trial / NCT07054190

A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

NCT07054190 ↗

Phase 2 Recruiting 120 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).

Timeline

Start
2025-09-09
Primary completion
2027-07-31
Completion
2027-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Giredestrant Small molecule — Oral
Subject Inavolisib Small molecule — Oral
Subject Letrozole Other / unclassified — Oral
Subject Ribociclib Small molecule — Oral

Indications