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 now · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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).

Key facts

Study ID

NCT06790693

Run by

Hoffmann-La Roche

People needed

450

Starts

2025-04-09

Expected to finish

2032-05-30

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• The Dignity Health Cancer Institute — Phoenix, Arizona, United States (enrolling)
• Disney Family Cancer Center — Burbank, California, United States (enrolling)
• City of Hope - Lennar Foundation Cancer Center — Irvine, California, United States (enrolling)
• Scripps Health — La Jolla, California, United States (enrolling)
• City Of Hope — Long Beach, California, United States (enrolling)
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States (enrolling)
• Ellison Institute of Technology — Los Angeles, California, United States (enrolling)
• Palo Alto Medical Foundation Research Center — Palo Alto, California, United States (enrolling)
• Kaiser Permanente - San Marcos — San Marcos, California, United States (enrolling)
• Palo Alto Medical Foundation Research Center — San Mateo, California, United States (enrolling)
• Palo Alto Medical Foundation Research Center — Sunnyvale, California, United States (enrolling)
• Cancer Specialists of North Florida - Jacksonville — Jacksonville, Florida, United States (enrolling)
• Tallahassee Memorial HealthCare — Tallahassee, Florida, United States (enrolling)
• Moffitt Cancer Center-McKinley Campus — Tampa, Florida, United States (enrolling)
• Cleveland Clinic Florida — Weston, Florida, United States (enrolling)
• Northwest Georgia Oncology Centers PC - Marietta — Marietta, Georgia, United States (enrolling)
• Cancer Care Specialists of Central Illinois — O'Fallon, Illinois, United States (enrolling)
• Springfield Clinic — Springfield, Illinois, United States (enrolling)
• Carle Cancer Center — Urbana, Illinois, United States (enrolling)
• City of Hope® Cancer Center Chicago — Zion, Illinois, United States (enrolling)
• Baptist Health Lexington — Lexington, Kentucky, United States (enrolling)
• Baptist Health Hamburg — Lexington, Kentucky, United States (enrolling)
• University of Kentucky - Markey Cancer Center — Lexington, Kentucky, United States (enrolling)
• University of Louisville Hospital — Louisville, Kentucky, United States (enrolling)
• City of Hope - Phoenix — Goodyear, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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