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Study identifier: NCT06790693 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Breast Cancer  ·  Sponsor: Hoffmann-La Roche

PhasePhase 3
Planned participants450
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

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).

This description comes directly from the study's public registry record.

Talk to the study team

Reference Study ID Number: WO45654 https://forpatients.roche.com/ No attachments to email below.  ·  888-662-6728 (U.S. Only)  ·  global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Always discuss trial participation with your own doctor first.

Locations (232)

The Dignity Health Cancer InstitutePhoenix, Arizona, United StatesRecruiting
Disney Family Cancer CenterBurbank, California, United StatesRecruiting
Scripps HealthLa Jolla, California, United StatesRecruiting
Cancer and Blood Specialty ClinicLos Alamitos, California, United StatesRecruiting
Ellison Institute of TechnologyLos Angeles, California, United StatesRecruiting
Palo Alto Medical Foundation Research CenterPalo Alto, California, United StatesRecruiting
Kaiser Permanente - San MarcosSan Marcos, California, United StatesRecruiting
Palo Alto Medical Foundation Research CenterSan Mateo, California, United StatesRecruiting
Palo Alto Medical Foundation Research CenterSunnyvale, California, United StatesRecruiting
Cancer Specialists of North Florida - JacksonvilleJacksonville, Florida, United StatesRecruiting
Tallahassee Memorial HealthCareTallahassee, Florida, United StatesRecruiting
Moffitt Cancer Center-McKinley CampusTampa, Florida, United StatesRecruiting

+ 220 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06790693