A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (NCT05646862)
A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.
Who can join: Review the eligibility criteria below.
Location: Cancer Blood and Specialty Clinic — Los Alamitos, California
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 (145 Sites)
Showing the first 25 of 145 sites.
- Cancer Blood and Specialty Clinic — Los Alamitos, California
- Los Angeles Cancer Network — Los Angeles, California
- UC Davis Comprehensive Cancer Center — Sacramento, California
- Rocky Mountain Cancer Centers — Denver, Colorado
- Cleveland Clinic Florida — Weston, Florida
- Grady Health System — Atlanta, Georgia
- Midtown West Medical — Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia
- Winship Cancer Institute at Emory Saint Joseph's Hospital — Atlanta, Georgia
- Massachusetts General Hospital — Boston, Massachusetts
- Cancer & Hematology Centers of Western Michigan — Grand Rapids, Michigan
- Minnesota Oncology Hematology — Saint Paul, Minnesota
- Asante Rogue Regional Medical Center — Medford, Oregon
- Texas Oncology - Dallas Presbyterian Hospital — Dallas, Texas
- Centro de Investigaciones Médicas y Desarrollo LC S.R.L — Buenos Aires,
- Centro Oncologico Korben — Ciudad Autonoma Buenos Aires,
- Fundacion CORI para la Investigacion y Prevencion del Cancer — La Rioja,
- Instituto de Oncología de Rosario — Rosario,
- Hosp Provincial D. Centenarios — Rosario,
- CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica — San Juan,
- Clinica Viedma S.A. — Viedma,
- Coffs Harbour Health Campus — Coffs Harbour, New South Wales
- Concord Repatriation General Hospital — Concord, New South Wales
- Kinghorn Cancer Centre — Darlinghurst, New South Wales
- Gosford Hospital — Gosford, New South Wales
💰 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.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.