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Inavolisib placebo

DRUG2 trials

Sponsors

F. Hoffmann-La Roche AG

Conditions

Endocrine-Resistant Hormone-Receptor-PositiveEndocrine-Sensitive phosphatidylinositol 3-kinase (PIK3CA)-MutatedHER2-Negative Advanced Breast Cancer with Chromosome 8p Loss and Without PIK3CA MutationHormone Receptor-Positivehuman epidermal growth factor receptor 2- (HER2-) negative advanced breast cancer

Phase 2

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib plus Ribociclib plus Fulvestrant Versus Placebo plus Ribociclib plus Fulvestrant in Patients with Endocrine-Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer with Chromosome 8P Loss and Without a PIK3CA Mutation
Not yet recruitingCTIS2025-523013-28-00
F. Hoffmann-La Roche AGEndocrine-Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer with Chromosome 8p Loss and Without PIK3CA Mutation
Target: 6Updated: 2026-03-23

Phase 3

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients with Endocrine-Sensitive PIK3CA -Mutated, Hormone Receptor-Positive, HER2- Negative Advanced Breast Cancer
RecruitingCTIS2024-516162-11-00
F. Hoffmann-La Roche AGEndocrine-Sensitive phosphatidylinositol 3-kinase (PIK3CA)-Mutated, Hormone Receptor-Positive, human epidermal growth factor receptor 2- (HER2-) negative advanced breast cancer
Start: 2025-07-14Target: 176Updated: 2025-11-10