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
Running, not enrolling · Phase 3
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT05646862
- Run by
- Hoffmann-La Roche
- People needed
- 420
- Starts
- 2023-06-07
- Expected to finish
- 2029-03-30
- Last updated by the study team
- 2026-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Los Angeles Cancer Network — Los Angeles, California, United States
- UC Davis Comprehensive Cancer Center — Sacramento, California, United States
- Rocky Mountain Cancer Centers — Denver, Colorado, United States
- Cleveland Clinic Florida — Weston, Florida, United States
- Grady Health System — Atlanta, Georgia, United States
- Midtown West Medical — Atlanta, Georgia, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Winship Cancer Institute at Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Cancer & Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States
- Minnesota Oncology Hematology — Saint Paul, Minnesota, United States
- Asante Rogue Regional Medical Center — Medford, Oregon, United States
- Texas Oncology - Dallas Presbyterian Hospital — Dallas, Texas, United States
- Centro de Investigaciones Médicas y Desarrollo LC S.R.L — Buenos Aires, Argentina
- Centro Oncologico Korben — Ciudad Autonoma Buenos Aires, Argentina
- Fundacion CORI para la Investigacion y Prevencion del Cancer — La Rioja, Argentina
- Instituto de Oncología de Rosario — Rosario, Argentina
- Hosp Provincial D. Centenarios — Rosario, Argentina
- CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica — San Juan, Argentina
- Clinica Viedma S.A. — Viedma, Argentina
- Coffs Harbour Health Campus — Coffs Harbour, New South Wales, Australia
- Concord Repatriation General Hospital — Concord, New South Wales, Australia
- Kinghorn Cancer Centre — Darlinghurst, New South Wales, Australia
- Gosford Hospital — Gosford, New South Wales, Australia
- Cancer Blood and Specialty Clinic — Los Alamitos, California, United States
Full record on ClinicalTrials.gov
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