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Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
Sponsor: Pfizer
Summary
The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer: * HR-positive (breast cancer cells that need estrogen or progesterone to grow) * HER2-negative (cells that have a small amount or none of a protein called HER2 on their surface); * locally advanced (that has spread from where it started to nearby tissue or lymph nodes) or metastatic disease (the spread of cancer to other places in the body) * who have not received any prior systemic anti-cancer treatment for advanced/metastatic disease. Approximately half of the participants will receive PF-07220060 plus letrozole while the other half of participants will receive the investigator's choice of treatment plus letrozole. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
Official title: AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO CDK4/6 INHIBITOR PLUS LETROZOLE IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTICANCER TREATMENT FOR ADVANCED/METASTATIC DISEASE (FOURLIGHT-3)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1035
Start Date
2025-01-06
Completion Date
2037-12-29
Last Updated
2026-05-19
Healthy Volunteers
No
Conditions
Interventions
PF-07220060
CDK4 inhibitor
letrozole
endocrine therapy
abemaciclib
CDK4/6 inhibitor
palbociclib
CDK4/6 inhibitor
ribociclib
CDK4/6 inhibitor
Locations (463)
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States
The University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Ironwood Cancer & Research Centers
Gilbert, Arizona, United States
Ironwood Cancer & Research Centers
Glendale, Arizona, United States
Ironwood Cancer & Research Centers
Goodyear, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Phoenix, Arizona, United States
Ironwood Cancer & Research Centers
Scottsdale, Arizona, United States
CARTI Cancer Center Saline County
Bryant, Arkansas, United States
CARTI Cancer Center Conway
Conway, Arkansas, United States
Highlands Oncology
Fayetteville, Arkansas, United States
CARTI Cancer Center
Little Rock, Arkansas, United States
CARTI Cancer Center North Little Rock Urology
North Little Rock, Arkansas, United States
CARTI Cancer Center North Little Rock
North Little Rock, Arkansas, United States
CARTI Cancer Center Pine Bluff
Pine Bluff, Arkansas, United States
Highlands Oncology
Rogers, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Providence Medical Foundation
Anaheim, California, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Sutter Health Alta Bates
Berkeley, California, United States
Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location)
Beverly Hills, California, United States
Cedars-Sinai Cancer Beverly Hills
Beverly Hills, California, United States
Marshall Cancer Center
Cameron Park, California, United States
Enloe Medical Center
Chico, California, United States
Enloe Regional Cancer Center
Chico, California, United States
City of Hope Investigational Drug Service (IDS)
Duarte, California, United States
City of Hope(City of Hope National Medical Center,City of Hope Medical Center)
Duarte, California, United States
UCSF Washington Hospital Cancer Center/ Washington Hospital Healthcare System
Fremont, California, United States
Premier Cancer Care and Infusion Center - Fresno - North Thesta Street
Fresno, California, United States
Providence Medical Foundation
Fullerton, California, United States
Providence St. Jude Medical Center
Fullerton, California, United States
City of Hope - Seacliff
Huntington Beach, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
City of Hope Investigational Drug Service (IDS)
Irvine, California, United States
Hoag Health Center Irvine
Irvine, California, United States
Hoag Hospital Irvine
Irvine, California, United States
City of Hope-Antelope Valley
Lancaster, California, United States
City of Hope at Long Beach Elm
Long Beach, California, United States
Cancer and Blood Research Center, LLC
Los Alamitos, California, United States
Cancer and Blood Specialty Clinic / Cancer and Blood Research Center, LLC
Los Alamitos, California, United States
Keck Hospital of USC
Los Angeles, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
Norris Healthcare Center 3 (HC3)
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Cedars-Sinai Cancer at Cedars-Sinai Medical Center (drug treatment and dispensing location)
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Ellison Medical Institute
Los Angeles, California, United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Keck Medicine of USC Norris Oncology/Hematology - Newport Beach Treatment Center
Newport Beach, California, United States
USC Norris Oncology/Hematology - Newport Beach
Newport Beach, California, United States
Sutter Health Palo Alto
Palo Alto, California, United States
Clinical and Translational Research Unit (CTRU)
Palo Alto, California, United States
Stanford Cancer Center
Palo Alto, California, United States
Stanford Women's Cancer Center
Palo Alto, California, United States
Keck Medical Center of USC Pasadena
Pasadena, California, United States
Marshall Hospital
Placerville, California, United States
UCLA Hematology/Oncology - Porter Ranch
Porter Ranch, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter Health - Sutter Institute for Medical Research
Sacramento, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
UCLA Hematology/Oncology - San Luis Obispo
San Luis Obispo, California, United States
Tower Saint John's Imaging
Santa Monica, California, United States
Providence Saint John's Health Center
Santa Monica, California, United States
UCLA Hematology/Oncology - Parkside
Santa Monica, California, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
City of Hope-South Pasadena
South Pasadena, California, United States
Stanford Health Care, Investigational Drug Service
Stanford, California, United States
Sutter Health Sunnyvale
Sunnyvale, California, United States
Cedars-Sinai Cancer Tarzana
Tarzana, California, United States
Cancer AND Blood Specialty Clinic
Torrance, California, United States
Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer
Torrance, California, United States
Tahoe Forest Cancer Center
Truckee, California, United States
City of Hope - Upland
Upland, California, United States
Wellness Oncology Hematology
West Hills, California, United States
Breast Health Services Building
West Hollywood, California, United States
UCLA Hematology/Oncology - Westlake
Westlake Village, California, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
Intermountain Health Lutheran Hospital
Golden, Colorado, United States
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, United States
Cancer Centers of Colorado St. Mary's Regional Hospital
Grand Junction, Colorado, United States
Intermountain Health Saint Mary's Regional Hospital
Grand Junction, Colorado, United States
Intermountain Health
Grand Junction, Colorado, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
AdventHealth Altamonte Infusion Center
Altamonte Springs, Florida, United States
AdventHealth Altamonte Springs
Altamonte Springs, Florida, United States
AdventHealth Medical Group Altamonte
Altamonte Springs, Florida, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
AdventHealth Medical Group Orlando
Orlando, Florida, United States
AdventHealth Orlando Infusion Center
Orlando, Florida, United States
Summit Cancer Care, PC
Savannah, Georgia, United States
St. Luke's Cancer Institute: Boise
Boise, Idaho, United States
St. Luke's Regional Medical Center
Boise, Idaho, United States
St. Luke's Cancer Institute-Fruitland
Fruitland, Idaho, United States
St. Luke's Cancer Institute-Meridian
Meridian, Idaho, United States
St. Lukes Meridian Medical Center
Meridian, Idaho, United States
St. Luke's Cancer Institute-Nampa
Nampa, Idaho, United States
Ingalls Family Care Center
Calumet City, Illinois, United States
UChicago Medicine - River East
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States
University of Chicago Medical Center, CCD
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Endeavor Health Cancer Institute at Swedish Hospital, Nancy W. Knowles Cancer Center
Elmhurst, Illinois, United States
Endeavor Health
Evanston, Illinois, United States
Prime Saint Francis-Infusion Services Evanston
Evanston, Illinois, United States
UChicago Medicine at Ingalls - Flossmoor
Flossmoor, Illinois, United States
UChicago Medicine Ingalls Memorial
Harvey, Illinois, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Endeavor Health Cancer Institute at Swedish Hospital
Naperville, Illinois, United States
Hope and Healing Cancer Services
New Lenox, Illinois, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States
The University of Chicago Medicine Center for Advanced Care Orland Park.
Orland Park, Illinois, United States
Memorial Hospital
Shiloh, Illinois, United States
Siteman Cancer Center - Shiloh
Shiloh, Illinois, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, United States
Prime Saint Francis-Infusion Services Skokie
Skokie, Illinois, United States
UChicago Medicine at Ingalls - Tinley Park
Tinley Park, Illinois, United States
UChicago Medicine - Northwest Indiana
Crown Point, Indiana, United States
Velocity Clinical Research
Annapolis, Maryland, United States
Mercy Medical Center - Baltimore
Baltimore, Maryland, United States
MedStar Health Research Institute, Inc
Columbia, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, United States
Allina Health Cancer Institute - Mercy Hospital
Coon Rapids, Minnesota, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Allina Health Cancer Institute - WestHealth
Plymouth, Minnesota, United States
Allina Health Cancer Institute - United Hospital
Saint Paul, Minnesota, United States
St. Francis Cancer Center
Shakopee, Minnesota, United States
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States
Siteman Cancer Center - North County
Florissant, Missouri, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Siteman Cancer Center
St Louis, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Renown Health Medical Oncology
Reno, Nevada, United States
Renown Office of Clinical Research
Reno, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
Renown Health Conrad Breast Center
Reno, Nevada, United States
Renown South Meadows Medical Center
Reno, Nevada, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
Jack & Sheryl Morris Cancer Center
New Brunswick, New Jersey, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
NYU Langone Health - Brooklyn
Brooklyn, New York, United States
Perlmutter Cancer Center - Sunset Park
Brooklyn, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Perlmutter Cancer Center at NYU Winthrop Hospital Infusion Center
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
NYU Langone Medical Center - Tisch Hospital
New York, New York, United States
University of Rochester Cancer Center Pharmacy
Rochester, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Stony Brook University
Stony Brook, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
University of North Carolina Hospitals at Hillsborough
Hillsborough, North Carolina, United States
Bon Secours Mercy Health, Inc
Cincinnati, Ohio, United States
Ohio State University Hospital
Columbus, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
Columbus, Ohio, United States
Stefanie Spielman Comprehensive Breast Cancer
Columbus, Ohio, United States
Oncology Associates of Oregon, P.C.
Albany, Oregon, United States