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 (NCT06790693)
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
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: City of Hope - Phoenix — Goodyear, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (239 Sites)
Showing the first 25 of 239 sites.
- City of Hope - Phoenix — Goodyear, Arizona
- The Dignity Health Cancer Institute — Phoenix, Arizona
- Disney Family Cancer Center — Burbank, California
- City of Hope - Lennar Foundation Cancer Center — Irvine, California
- Scripps Health — La Jolla, California
- City Of Hope — Long Beach, California
- Cancer and Blood Specialty Clinic — Los Alamitos, California
- Ellison Institute of Technology — Los Angeles, California
- Palo Alto Medical Foundation Research Center — Palo Alto, California
- Kaiser Permanente - San Marcos — San Marcos, California
- Palo Alto Medical Foundation Research Center — San Mateo, California
- Palo Alto Medical Foundation Research Center — Sunnyvale, California
- Cancer Specialists of North Florida - Jacksonville — Jacksonville, Florida
- Tallahassee Memorial HealthCare — Tallahassee, Florida
- Moffitt Cancer Center-McKinley Campus — Tampa, Florida
- Cleveland Clinic Florida — Weston, Florida
- Northwest Georgia Oncology Centers PC - Marietta — Marietta, Georgia
- Cancer Care Specialists of Central Illinois — O'Fallon, Illinois
- Springfield Clinic — Springfield, Illinois
- Carle Cancer Center — Urbana, Illinois
- City of Hope® Cancer Center Chicago — Zion, Illinois
- Baptist Health Lexington — Lexington, Kentucky
- Baptist Health Hamburg — Lexington, Kentucky
- University of Kentucky - Markey Cancer Center — Lexington, Kentucky
- University of Louisville Hospital — Louisville, Kentucky
📞 Contact the Study Coordinator
Phone: (888) 662-6728
Email: global-roche-genentech-trials@gene.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.