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Clinical Trials in the UK / NCT06790693
Recruiting Phase 3

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

NCT06790693 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2025-04-09
Last updated
2026-09-03

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

InavolisibPlaceboCDK4/6iLetrozole

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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (241)

FacilityCityRegionStatus
City of Hope - Phoenix Goodyear Arizona Recruiting
The Dignity Health Cancer Institute Phoenix Arizona Recruiting
Disney Family Cancer Center Burbank California Recruiting
City of Hope - Lennar Foundation Cancer Center Irvine California Recruiting
Scripps Health La Jolla California Recruiting
City Of Hope Long Beach California Recruiting
Cancer and Blood Specialty Clinic Los Alamitos California Recruiting
Ellison Medical Institute Los Angeles California Recruiting
Palo Alto Medical Foundation Research Center Palo Alto California Recruiting
Kaiser Permanente - San Marcos San Marcos California Recruiting
Palo Alto Medical Foundation Research Center San Mateo California Recruiting
Palo Alto Medical Foundation Research Center Sunnyvale California Recruiting
Cancer Specialists of North Florida - Jacksonville Jacksonville Florida Recruiting
Tallahassee Memorial HealthCare Tallahassee Florida Recruiting
Moffitt Cancer Center-McKinley Campus Tampa Florida Recruiting
Cleveland Clinic Florida Weston Florida Recruiting
Northwest Georgia Oncology Centers PC - Marietta Marietta Georgia Recruiting
Cancer Care Specialists of Central Illinois O'Fallon Illinois Recruiting
Springfield Clinic Springfield Illinois Recruiting
Carle Cancer Center Urbana Illinois Recruiting
City of Hope® Cancer Center Chicago Zion Illinois Recruiting
Baptist Health Lexington Lexington Kentucky Recruiting
Baptist Health Hamburg Lexington Kentucky Recruiting
University of Kentucky - Markey Cancer Center Lexington Kentucky Recruiting
University of Louisville Hospital Louisville Kentucky Recruiting
Baptist Health Louisville Louisville Kentucky Recruiting
Velocity Clinical Research Annapolis Maryland Recruiting
University of Maryland Baltimore Maryland Recruiting
Henry Ford Health System Detroit Michigan Recruiting
Cancer & Hematology Centers of Western Michigan Grand Rapids Michigan Recruiting
University of Minnesota Medical Center Minneapolis Minnesota Recruiting
HCA Midwest Health Kansas City Missouri Recruiting
Nebraska Cancer Specialists Grand Island Nebraska Recruiting
Nebraska Cancer Specialists Omaha Nebraska Recruiting
Astera Cancer Care East Brunswick East Brunswick New Jersey Recruiting
Summit Medical Group Florham Park New Jersey Recruiting
The Blavatnik Family ? Chelsea Medical Center at Mount Sinai New York New York Recruiting
Mount Sinai West New York New York Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting

+ 201 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06790693 on ClinicalTrials.gov ↗ ← All trials in the UK