NCT06790693

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Inavolisib	Participants will receive oral inavolisib once daily (QD).
DRUG	Placebo	Participants will receive oral placebo QD.
DRUG	CDK4/6i	Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.
DRUG	Letrozole	Participants will receive oral letrozole QD.

Timeline

• Start date: 2025-04-09
• Primary completion: 2032-05-30
• Completion: 2032-05-30
• First posted: 2025-01-24
• Last updated: 2026-04-03

Locations

219 sites across 20 countries: United States, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Mexico, Poland, Puerto Rico, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study