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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06790693

Public ClinicalTrials.gov record NCT06790693. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 24, 2026, 12:17 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT06790693
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
450 participants

Conditions and interventions

Conditions

Interventions

  • Inavolisib Drug
  • Placebo Drug
  • CDK4/6i Drug
  • Letrozole Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 8, 2025
Primary completion
May 29, 2032
Completion
May 29, 2032
Last update posted
Jul 1, 2026

2025 – 2032

United States locations

U.S. sites
54
U.S. states
22
U.S. cities
45
Facility City State ZIP Site status
The Dignity Health Cancer Institute Phoenix Arizona 85004 Recruiting
Disney Family Cancer Center Burbank California 91505 Recruiting
Scripps Health La Jolla California 92040 Recruiting
Cancer and Blood Specialty Clinic Los Alamitos California 90720 Recruiting
Ellison Institute of Technology Los Angeles California 90064 Recruiting
Palo Alto Medical Foundation Research Center Palo Alto California 94301 Recruiting
Kaiser Permanente - San Marcos San Marcos California 92069 Recruiting
Palo Alto Medical Foundation Research Center San Mateo California 94401 Recruiting
Palo Alto Medical Foundation Research Center Sunnyvale California 94086 Recruiting
Cancer Specialists of North Florida - Jacksonville Jacksonville Florida 32207 Recruiting
Tallahassee Memorial HealthCare Tallahassee Florida 32308 Recruiting
Moffitt Cancer Center-McKinley Campus Tampa Florida 33612 Recruiting
Cleveland Clinic Florida Weston Florida 33331 Recruiting
Northwest Georgia Oncology Centers PC - Marietta Marietta Georgia 30060 Recruiting
Cancer Care Specialists of Central Illinois O'Fallon Illinois 62269 Recruiting
Springfield Clinic Springfield Illinois 62702 Recruiting
Carle Cancer Center Urbana Illinois 61801 Recruiting
Baptist Health Lexington Lexington Kentucky 40503 Recruiting
Baptist Health Hamburg Lexington Kentucky 40509 Recruiting
University of Kentucky - Markey Cancer Center Lexington Kentucky 40536 Recruiting
University of Louisville Hospital Louisville Kentucky 40202 Recruiting
Baptist Health Louisville Louisville Kentucky 40207 Recruiting
Velocity Clinical Research Annapolis Maryland 21401 Recruiting
University of Maryland Baltimore Maryland 21201 Recruiting
Henry Ford Health System Detroit Michigan 48202 Recruiting
Cancer & Hematology Centers of Western Michigan Grand Rapids Michigan 49503 Recruiting
University of Minnesota Medical Center Minneapolis Minnesota 55455 Recruiting
HCA Midwest Health Kansas City Missouri 64132 Recruiting
Nebraska Cancer Specialists Grand Island Nebraska 68803 Recruiting
Nebraska Cancer Specialists Omaha Nebraska 68130-2042 Recruiting
Astera Cancer Care East Brunswick East Brunswick New Jersey 08816 Recruiting
Summit Medical Group Florham Park New Jersey 07932 Recruiting
The Blavatnik Family ? Chelsea Medical Center at Mount Sinai New York New York 10011 Recruiting
Mount Sinai West New York New York 10019 Recruiting
Icahn School of Medicine at Mount Sinai New York New York 10029 Recruiting
Memorial Sloan Kettering Cancer Center New York New York 10065 Recruiting
Duke Cancer Institute Durham North Carolina 27710 Recruiting
Fairview Hospital Cleveland Ohio 44111 Recruiting
Cleveland Clinic Foundation Cleveland Ohio 44915 Recruiting
Hillcrest Hospital Mayfield Heights Ohio 44124 Recruiting
Providence Portland Medical Center Portland Oregon 97213 Recruiting
Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services Pharmacy Portland Oregon 97225 Recruiting
UPMC Hillman Cancer Center - Magee-Women?s Hospital Pittsburgh Pennsylvania 15213 Recruiting
Bon Secours - St. Francis Hospital Greenville South Carolina 29607 Recruiting
West Cancer Center Germantown Tennessee 38138 Recruiting
Vanderbilt University Medical Center Nashville Tennessee 37204 Recruiting
JPS Health Network Fort Worth Texas 76104 Recruiting
Community Clinical Trials Kingwood Texas 77339 Recruiting
Huntsman Cancer Hospital at the University of Utah Salt Lake City Utah 84113 Recruiting
Swedish Cancer Institute - Edmonds Campus Edmonds Washington 98026 Recruiting
Providence Regional Cancer Partnership Everett Washington 98201-1621 Recruiting
Swedish Cancer Institute - Issaquah Seattle Washington 98104 Recruiting
Swedish Cancer Institute Seattle Washington 98104 Recruiting
Northwest Medical Specialties Tacoma Washington 98405 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 178 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06790693, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 1, 2026 · Synced Jul 24, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06790693 live on ClinicalTrials.gov.

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