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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
Sponsor: Hoffmann-La Roche
Summary
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2025-04-09
Completion Date
2032-02-01
Last Updated
2026-11-04
Healthy Volunteers
No
Conditions
Interventions
Inavolisib
Participants will receive oral inavolisib once daily (QD).
Placebo
Participants will receive oral placebo QD.
CDK4/6i
Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.
Letrozole
Participants will receive oral letrozole QD.
Locations (242)
City of Hope - Phoenix
Goodyear, Arizona, United States
The Dignity Health Cancer Institute
Phoenix, Arizona, United States
Disney Family Cancer Center
Burbank, California, United States
City of Hope - Lennar Foundation Cancer Center
Irvine, California, United States
Scripps Health
La Jolla, California, United States
City Of Hope
Long Beach, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Ellison Medical Institute
Los Angeles, California, United States
Palo Alto Medical Foundation Research Center
Palo Alto, California, United States
Kaiser Permanente - San Marcos
San Marcos, California, United States
Palo Alto Medical Foundation Research Center
San Mateo, California, United States
Palo Alto Medical Foundation Research Center
Sunnyvale, California, United States
Cancer Specialists of North Florida - Jacksonville
Jacksonville, Florida, United States
Tallahassee Memorial HealthCare
Tallahassee, Florida, United States
Moffitt Cancer Center-McKinley Campus
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States
Cancer Care Specialists of Central Illinois
O'Fallon, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
City of Hope® Cancer Center Chicago
Zion, Illinois, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Baptist Health Hamburg
Lexington, Kentucky, United States
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Baptist Health Louisville
Louisville, Kentucky, United States
Velocity Clinical Research
Annapolis, Maryland, United States
University of Maryland
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
HCA Midwest Health
Kansas City, Missouri, United States
Nebraska Cancer Specialists
Grand Island, Nebraska, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, United States
Summit Medical Group
Florham Park, New Jersey, United States
The Blavatnik Family ? Chelsea Medical Center at Mount Sinai
New York, New York, United States
Mount Sinai West
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
New York Cancer & Blood Specialists
Shirley, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Novant Health Cancer Institute
Charlotte, North Carolina, United States
Duke Cancer Institute
Durham, North Carolina, United States
Novant Health Cancer Institute
Winston-Salem, North Carolina, United States
Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hillcrest Hospital
Mayfield Heights, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services Pharmacy
Portland, Oregon, United States
UPMC Hillman Cancer Center - Magee-Women?s Hospital
Pittsburgh, Pennsylvania, United States
Bon Secours - St. Francis Hospital
Greenville, South Carolina, United States
West Cancer Center
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
JPS Health Network
Fort Worth, Texas, United States
Community Clinical Trials
Spring, Texas, United States
Huntsman Cancer Hospital at the University of Utah
Salt Lake City, Utah, United States
Swedish Cancer Institute - Edmonds Campus
Edmonds, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Swedish Cancer Institute - Issaquah
Seattle, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Centro Oncologico Korben
Caba, Argentina
Centro Médico Fleischer
Capital Federal, Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, Argentina
Instituto de Oncologia de Rosario
Rosario, Argentina
Centro Oncológico de Excelencia
San Juan, Argentina
Blacktown Hospital
Blacktown, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Maroondah hospital;Oncology clinical trials
Ringwood, Victoria, Australia
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
Hospital Santa Rita de Cassia Vitoria
Vitória, Espírito Santo, Brazil
Obras Sociais Irma Dulce - Osid
Salvador, Estado de Bahia, Brazil
Hospital Araujo Jorge
Goiânia, Goiás, Brazil
Centro de Oncologia de Alfenas
Alfenas, Minas Gerais, Brazil
Hospital do Câncer de Londrina
Londrina, Paraná, Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil
Vencer Oncoclínica - Centro de Pesquisa do Piauí
Teresina, Piauí, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
Instituto Nacional de Cancer - INCa
Rio de Janeiro, Brazil
Arthur J.E. Child Comprehensive Cancer Center
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
The Moncton Hospital
Moncton, New Brunswick, Canada
The Ottawa Hospital Cancer Center
Ottawa, Ontario, Canada
Sault Area Hospital
Sault Ste. Marie, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Joseph's Health Centre
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec, Canada
Unité de Recherche Clinique du CISSS de Laurentides
Saint-Jérôme, Quebec, Canada
Xiangyang Central Hospital
Xiangyang, Hubei, China
Peking Union Medical College Hospital
Beijing, China
Hunan Cancer Hospital
Changsha, China