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ACTIVE NOT RECRUITING

NCT06760637

PHASE3

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

View on ClinicalTrials.gov

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

2026-10-16

Healthy Volunteers

Conditions

Breast Cancer

Interventions

DRUG

PF-07220060

CDK4 inhibitor

DRUG

letrozole

endocrine therapy

DRUG

abemaciclib

CDK4/6 inhibitor

DRUG

palbociclib

CDK4/6 inhibitor

DRUG

ribociclib

CDK4/6 inhibitor

Locations (460)

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 Group, PA

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 Group, PA

Rogers, Arkansas, United States

Highlands Oncology Group, PA

Springdale, Arkansas, 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 Virginia K Crosson Cancer Center & Infusion 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