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
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 studied
Breast Cancer
About this study
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).
Interventions
- 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.
Primary outcomes
- Progression-Free Survival (PFS) (From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years))
Eligibility information
Study locations
- City of Hope - Phoenix, Goodyear, Arizona 85338 United States
- The Dignity Health Cancer Institute, Phoenix, Arizona 85004 United States
- Disney Family Cancer Center, Burbank, California 91505 United States
- City of Hope - Lennar Foundation Cancer Center, Irvine, California 92618 United States
- Scripps Health, La Jolla, California 92040 United States
- City Of Hope, Long Beach, California 90813 United States
- Cancer and Blood Specialty Clinic, Los Alamitos, California 90720 United States
- Ellison Medical Institute, Los Angeles, California 90064 United States
- Palo Alto Medical Foundation Research Center, Palo Alto, California 94301 United States
- Kaiser Permanente - San Marcos, San Marcos, California 92069 United States
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Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-13.