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
Recruiting · NCT06790693 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Women or men with histologically or cytologically confirmed carcinoma of the breast
- Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
- Documented HER2-negative tumor according to ASCO/CAP guidelines
- De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment
- Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
- Confirmation of biomarker eligibility
- Consent to provide fresh or archival tumor tissue specimen
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Exclusion criteria
- Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
- Metaplastic breast cancer
- Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Any history of leptomeningeal disease or carcinomatous meningitis
- Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible
- Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
- Symptomatic active lung disease
- History of or active inflammatory bowel disease
- Any active bowel inflammation
- Prior hematopoietic stem cell or bone marrow transplantation
- Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment
Where it is running
60 locations listed across 22 US states.
- 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
- 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
Showing 60 of 241 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →