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.
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).
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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