Breast CancerPhase 3FourLight-3NCT06760637
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
A Phase 3 study testing PF-07220060, letrozole and abemaciclib in people with Breast Cancer, run by Pfizer at 460 sites in 30 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PF-07220060, letrozole and abemaciclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,035 participants
- Where
- 460 sitesin 30 countries
- Study dates
- 6 Jan 2025to 29 Dec 2037
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- Documented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor
- Documented HER2-negative tumor
- Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease.
- Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1
Who cannot join
- In visceral crisis at risk of immediately life-threatening complications in the short term.
- Current or past history of central nervous system metastases.
- Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET.
- Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i.
- Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.
Trial locations and contacts
460 sites in 30 countries.
460 sites in 30 countries
United States216 sites
Oncology Associates of Oregon, P.C.
Albany, Oregon, 97321
AdventHealth Altamonte Infusion Center
Altamonte Springs, Florida, 32701
AdventHealth Altamonte Springs
Altamonte Springs, Florida, 32701
AdventHealth Medical Group Altamonte
Altamonte Springs, Florida, 32701
Velocity Clinical Research
Annapolis, Maryland, 21401
Texas Oncology - DFW
Arlington, Texas, 76012
Texas Oncology - DFW
Arlington, Texas, 76014
Sutter Auburn Faith Hospital
Auburn, California, 95602
Mercy Medical Center - Baltimore
Baltimore, Maryland, 21202
Texas Oncology - DFW
Bedford, Texas, 76022
Sutter Health Alta Bates
Berkeley, California, 94704
Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location)
Beverly Hills, California, 90211
Cedars-Sinai Cancer Beverly Hills
Beverly Hills, California, 90211
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233
The University of Alabama at Birmingham
Birmingham, Alabama, 35249
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35249
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
St. Luke's Cancer Institute: Boise
Boise, Idaho, 83712
St. Luke's Regional Medical Center
Boise, Idaho, 83712
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Utah Cancer Specialists
Bountiful, Utah, 84010
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
NYU Langone Health - Brooklyn
Brooklyn, New York, 11220
Perlmutter Cancer Center - Sunset Park
Brooklyn, New York, 11220
CARTI Cancer Center Saline County
Bryant, Arkansas, 72022
Ingalls Family Care Center
Calumet City, Illinois, 60409
Marshall Cancer Center
Cameron Park, California, 95682
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514
UChicago Medicine - River East
Chicago, Illinois, 60611
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612
University of Chicago Medical Center, CCD
Chicago, Illinois, 60637
University of Chicago Medical Center
Chicago, Illinois, 60637
Enloe Medical Center
Chico, California, 95926
Enloe Regional Cancer Center
Chico, California, 95926
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, 63376
MedStar Health Research Institute, Inc
Columbia, Maryland, 21044
Ohio State University Hospital
Columbus, Ohio, 43210
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
Columbus, Ohio, 43210
Stefanie Spielman Comprehensive Breast Cancer
Columbus, Ohio, 43212
CARTI Cancer Center Conway
Conway, Arkansas, 72034
Allina Health Cancer Institute - Mercy Hospital
Coon Rapids, Minnesota, 55433
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141
UChicago Medicine - Northwest Indiana
Crown Point, Indiana, 46307
Texas Oncology - DFW
Dallas, Texas, 75203
Texas Oncology - DFW
Dallas, Texas, 75230
Texas Oncology - DFW
Dallas, Texas, 75231
Texas Oncology - DFW
Dallas, Texas, 75237
Texas Oncology - DFW
Dallas, Texas, 75246
Denver Health and Hospital Authority
Denver, Colorado, 80204
City of Hope Investigational Drug Service (IDS)
Duarte, California, 91010
City of Hope(City of Hope National Medical Center,City of Hope Medical Center)
Duarte, California, 91010
Endeavor Health Cancer Institute at Swedish Hospital, Nancy W. Knowles Cancer Center
Elmhurst, Illinois, 60126
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
Endeavor Health
Evanston, Illinois, 60201
Prime Saint Francis-Infusion Services Evanston
Evanston, Illinois, 60202
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72703
Siteman Cancer Center - North County
Florissant, Missouri, 63031
UChicago Medicine at Ingalls - Flossmoor
Flossmoor, Illinois, 60422
Texas Oncology - DFW
Fort Worth, Texas, 76104
UCSF Washington Hospital Cancer Center/ Washington Hospital Healthcare System
Fremont, California, 94538
Premier Cancer Care and Infusion Center - Fresno - North Thesta Street
Fresno, California, 93710
St. Luke's Cancer Institute-Fruitland
Fruitland, Idaho, 83619
Providence Medical Foundation
Fullerton, California, 92835
Providence St. Jude Medical Center Virginia K Crosson Cancer Center & Infusion Center
Fullerton, California, 92835
Ironwood Cancer & Research Centers
Gilbert, Arizona, 85297
Ironwood Cancer & Research Centers
Glendale, Arizona, 85306
Intermountain Health Lutheran Hospital
Golden, Colorado, 80401
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, 80401
Ironwood Cancer & Research Centers
Goodyear, Arizona, 85395
Cancer Centers of Colorado St. Mary's Regional Hospital
Grand Junction, Colorado, 81501
Intermountain Health Saint Mary's Regional Hospital
Grand Junction, Colorado, 81501
Intermountain Health
Grand Junction, Colorado, 81505
Texas Oncology - DFW
Grapevine, Texas, 76051
UChicago Medicine Ingalls Memorial
Harvey, Illinois, 60426
University of North Carolina Hospitals at Hillsborough
Hillsborough, North Carolina, 27278
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
City of Hope - Seacliff
Huntington Beach, California, 92648
City of Hope at Irvine Lennar
Irvine, California, 92618
City of Hope Investigational Drug Service (IDS)
Irvine, California, 92618
Hoag Health Center Irvine
Irvine, California, 92618
Hoag Hospital Irvine
Irvine, California, 92618
US Oncology Investigational Product Center (IPC)
Irving, Texas, 75063
US Oncology Investigational Products Center
Irving, Texas, 75063
US Oncology lnvestigational Products Center (IPC)
Irving, Texas, 75063
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
City of Hope-Antelope Valley
Lancaster, California, 93534
Utah Cancer Specialists
Layton, Utah, 84041
CARTI Cancer Center
Little Rock, Arkansas, 72205
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
City of Hope at Long Beach Elm
Long Beach, California, 90813
Cancer and Blood Research Center, LLC
Los Alamitos, California, 90720
Cancer and Blood Specialty Clinic / Cancer and Blood Research Center, LLC
Los Alamitos, California, 90720
Keck Hospital of USC
Los Angeles, California, 90033
Los Angeles General Medical Center
Los Angeles, California, 90033
Norris Healthcare Center 3 (HC3)
Los Angeles, California, 90033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Cedars-Sinai Cancer at Cedars-Sinai Medical Center (drug treatment and dispensing location)
Los Angeles, California, 90048
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Ellison Medical Institute
Los Angeles, California, 90064
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Virginia Cancer Specialists, PC
Manassas, Virginia, 20110
Bon Secours Cancer Institute at Memorial Regional
Mechanicsville, Virginia, 23116
St. Luke's Cancer Institute-Meridian
Meridian, Idaho, 83642
St. Lukes Meridian Medical Center
Meridian, Idaho, 83642
Ironwood Cancer & Research Centers
Mesa, Arizona, 85202
Ironwood Cancer & Research Centers
Mesa, Arizona, 85206
Bon Secours St. Francis Medical Center
Midlothian, Virginia, 23114
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
Perlmutter Cancer Center at NYU Winthrop Hospital Infusion Center
Mineola, New York, 11501
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Utah Cancer Specialists
Murray, Utah, 84107
St. Luke's Cancer Institute-Nampa
Nampa, Idaho, 83687
Endeavor Health Cancer Institute at Swedish Hospital
Naperville, Illinois, 60540
Jack & Sheryl Morris Cancer Center
New Brunswick, New Jersey, 08901
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Hope and Healing Cancer Services
New Lenox, Illinois, 60451
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, 60451
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
NYU Langone Medical Center - Tisch Hospital
New York, New York, 10016
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Keck Medicine of USC Norris Oncology/Hematology - Newport Beach Treatment Center
Newport Beach, California, 92663
USC Norris Oncology/Hematology - Newport Beach
Newport Beach, California, 92663
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02459
CARTI Cancer Center North Little Rock Urology
North Little Rock, Arkansas, 72117
CARTI Cancer Center North Little Rock
North Little Rock, Arkansas, 72117
Utah Cancer Specialists
Ogden, Utah, 84405
Utah Cancer Specialists
Orem, Utah, 84057
The University of Chicago Medicine Center for Advanced Care Orland Park.
Orland Park, Illinois, 60462
AdventHealth Orlando
Orlando, Florida, 32803
AdventHealth Medical Group Orlando
Orlando, Florida, 32804
AdventHealth Orlando Infusion Center
Orlando, Florida, 32804
Sutter Health Palo Alto
Palo Alto, California, 94301
Clinical and Translational Research Unit (CTRU)
Palo Alto, California, 94304
Stanford Cancer Center
Palo Alto, California, 94304
Stanford Women's Cancer Center
Palo Alto, California, 94304
Keck Medical Center of USC Pasadena
Pasadena, California, 91105
Ironwood Cancer & Research Centers
Phoenix, Arizona, 85028
CARTI Cancer Center Pine Bluff
Pine Bluff, Arkansas, 71603
Marshall Hospital
Placerville, California, 95667
Texas Oncology - DFW
Plano, Texas, 75075
Texas Oncology - DFW
Plano, Texas, 75093
Utah Cancer Specialists
Pleasant Grove, Utah, 84062
Allina Health Cancer Institute - WestHealth
Plymouth, Minnesota, 55441
UCLA Hematology/Oncology - Porter Ranch
Porter Ranch, California, 91326
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
Providence Portland Medical Center Investigational Drug Services
Portland, Oregon, 97213
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Investigational Drug Service - Westside
Portland, Oregon, 97225
Providence Oncology and Hematology Care Clinic - Westside
Portland, Oregon, 97225
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Utah Cancer Specialists
Provo, Utah, 84604
Renown Health Medical Oncology
Reno, Nevada, 89502
Renown Office of Clinical Research
Reno, Nevada, 89502
Renown Regional Medical Center
Reno, Nevada, 89502
Renown Health Conrad Breast Center
Reno, Nevada, 89521
Renown South Meadows Medical Center
Reno, Nevada, 89521
Virginia Cancer Specialists, PC
Reston, Virginia, 20190
Bon Secours Cancer Institute at St. Mary's
Richmond, Virginia, 23226
University of Rochester Cancer Center Pharmacy
Rochester, New York, 14642
University of Rochester Medical Center
Rochester, New York, 14642
Highlands Oncology Group, PA
Rogers, Arkansas, 72758
Sutter Roseville Medical Center
Roseville, California, 95661
Baylor Scott & White Health - Round Rock
Round Rock, Texas, 78665
Baylor Scott & White Research Institute - Round Rock
Round Rock, Texas, 78665
Sutter Health - Sutter Institute for Medical Research
Sacramento, California, 95816
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, 95817
University of California Davis Medical Center
Sacramento, California, 95817
Allina Health Cancer Institute - United Hospital
Saint Paul, Minnesota, 55102
Utah Cancer Specialists
Salt Lake City, Utah, 84102
Utah Cancer Specialists
Salt Lake City, Utah, 84106
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
UCLA Hematology/Oncology - San Luis Obispo
San Luis Obispo, California, 93401
Tower Saint John's Imaging
Santa Monica, California, 90403
Providence Saint John's Health Center
Santa Monica, California, 90404
UCLA Hematology/Oncology - Parkside
Santa Monica, California, 90404
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404
Summit Cancer Care, PC
Savannah, Georgia, 31405
Ironwood Cancer & Research Centers
Scottsdale, Arizona, 85260
St. Francis Cancer Center
Shakopee, Minnesota, 55379
Memorial Hospital
Shiloh, Illinois, 62269
Siteman Cancer Center - Shiloh
Shiloh, Illinois, 62269
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077
Prime Saint Francis-Infusion Services Skokie
Skokie, Illinois, 60077
City of Hope-South Pasadena
South Pasadena, California, 91030
Highlands Oncology Group, PA
Springdale, Arkansas, 72762
Oncology Associates of Oregon, P.C.
Springfield, Oregon, 97477
Siteman Cancer Center
St Louis, Missouri, 63108
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
Siteman Cancer Center - South County
St Louis, Missouri, 63129
Stanford Health Care, Investigational Drug Service
Stanford, California, 94305
Stony Brook University
Stony Brook, New York, 11794
Sutter Health Sunnyvale
Sunnyvale, California, 94086
Cedars-Sinai Cancer Tarzana
Tarzana, California, 91356
UChicago Medicine at Ingalls - Tinley Park
Tinley Park, Illinois, 60477
Cancer AND Blood Specialty Clinic
Torrance, California, 90505
Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer
Torrance, California, 90505
Tahoe Forest Cancer Center
Truckee, California, 96161
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center
Tyler, Texas, 75701
The University of Texas Health Science Center at Tyler on behalf of UT Health East Texas HOPE Cancer
Tyler, Texas, 75708
City of Hope - Upland
Upland, California, 91786
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wellness Oncology Hematology
West Hills, California, 91307
Breast Health Services Building
West Hollywood, California, 90048
Utah Cancer Specialists
West Jordan, Utah, 84088
Utah Cancer Specialists
West Valley City, Utah, 84119
UCLA Hematology/Oncology - Westlake
Westlake Village, California, 91361
China26 sites
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142
The First Hospital of Jilin University
Changchun, Jilin, 130021
Hunan Cancer Hospital
Changsha, Hunan, 410013
The 2nd Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116023
The First People's Hospital of Foshan
Foshan, Guangdong, 528000
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031
Shandong Cancer Hospital
Jinan, Shandong, 250117
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317004
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210031
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
The First Hospital of China Medical University
Shenyang, Liaoning, 110015
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Wuhan Union Hospital Cancer Center
Wuhan, Hubei, 430022
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Hubei Cancer Hospital
Wuhan, Hubei, 430079
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Japan20 sites
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Chiba Cancer Center
Chiba, 260-8717
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Kumamoto Shinto General Hospital
Kumamoto, 862-8655
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Okayama University Hospital
Okayama, 700-8558
National Hospital Organization Osaka National Hospital
Osaka, 540-0006
Gunma Prefectural Cancer Center
Otashi, Gunma, 373-8550
Kyoto University Hospital
Sakyo-ku, Kyoto, 606-8507
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Showa University Hospital
Shinagawa, Tokyo, 142-8666
National Center for Global Health and Medicine
Shinjuku, Tokyo, 162-8655
Osaka University Hospital
Suita, Osaka, 565-0871
Kanagawa cancer center
Yokohama, Kanagawa, 2418515
Spain20 sites
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña], 15006
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], 08036
Fundació de Recerca Clínic Barcelona
Barcelona, 08036
Osi Bilbao-Basurto
Bilbao, Basque Country, 48013
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Región de, 30120
Hospital General Universitario de Elche
Elche, Alicante, 03203
Hospital Universitario Clinico San Cecilio
Granada, 18016
Hospital Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Barcelona [barcelona], 08908
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041
Hospital Beata María Ana
Madrid, 28007
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario HM Sanchinarro
Madrid, 28050
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29010
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009
Hospital Universitario Virgen Del Rocio
Seville, 41013
Fundación Instituto Valenciano de Oncología
Valencia, Valenciana, Comunitat, 46009
Hospital Arnau de Vilanova
Valencia, València, 46015
South Korea14 sites
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, Seoul-teukbyeolsi [seoul], 06273
National Cancer Center
Goyang-si, Kyǒnggi-do, 10408
Gachon University Gil Medical Center
Incheon, Incheon-gwangyeoksi [incheon], 21565
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 13496
Korea University Anam Hospital
Seoul, Seoul-teukbyeolsi [seoul], 02841
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080
Kangbuk Samsung Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03181
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 05505
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], 06591
Ewha Womans University Mokdong Hospital
Seoul, Seoul-teukbyeolsi [seoul], 07985
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [seoul], 08308
France13 sites
Institut de Cancérologie de l'Ouest
Angers, Maine-et-loire, 49055
Centre Hospitalier de la Côte Basque
Bayonne, Aquitaine, 64100
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine, 33076
Henri Mondor Hospital
Créteil, Île-de-France Region, 94010
CHD Vendee
La Roche-sur-Yon, 85925
Centre Oscar Lambret
Lille, Hauts-de-France, 59020
Centre de Cancérologie du Grand Montpellier
Montpellier, Languedoc-roussillon, 34070
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, 69310
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer
Rennes, Ille-et-vilaine, 35042
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
Rouen, Seine-maritime, 76038
Institut Curie - site Saint-Cloud
Saint-Cloud, Hauts-de-seine, 92210
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire-atlantique, 44805
Gustave Roussy
Villejuif, Val-de-marne, 94800
Brazil12 sites
Hospital Brasilia
Brasília, Federal District, 71.635-610
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336232
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, Rio Grande do Sul, 98700-000
Associação Hospitalar Beneficente São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-080
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-090
Santa Casa de Misericordia de Passos
Passos, Minas Gerais, 37904-020
Real Hospital Portugues
Recife, Pernambuco, 52010-075
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, 01327-001
IBCC - Instituto Brasileiro de Controle do Câncer
São Paulo, 03102-002
IBCC - Núcleo de Pesquisa e Ensino
São Paulo, 04014-002
Hospital Santa Rita de Cassia
Vitória, Espírito Santo, 29043-260
Turkey (Türkiye)12 sites
Adana Medical Park Seyhan Hastanesi
Adana, 01140
Adana City Hospital
Adana, 01370
Gulhane Egitim Arastirma Hastanesi
Ankara, 06010
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara, 06200
Hacettepe Universite Hastaneleri
Ankara, 06230
Memorial Ankara Hastanesi
Ankara, 06520
Gazi University Health Research and Application Center Gazi Hospital
Ankara, 06560
Dicle Üniversitesi
Diyarbakır, 21200
Medipol Mega Universite Hastanesi
Istanbul, İ̇stanbul, 34214
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, İ̇stanbul, 34722
Ege Universitesi Hastanesi
Izmir, İ̇zmir, 35100
Sakarya Training and Research Hospital
Sakarya, 54290
India11 sites
Spandana Oncology Centre (SOC)
Bangalore, Karnataka, 560069
Artemis hospital
Gurugram, Haryana, 122001
Basavatarakam Indo American Cancer Hospital & Research Institute
Hyderabad, Telangana, 500034
Apollo Multispeciality Hospitals limited
Kolkata, West Bengal, 700054
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Apex Wellness Hospital
Nashik, Maharashtra, 422009
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, 110085
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, 395002
Bhakti Vedanta Hospital and Research Institute
Thane, Maharashtra, 401107
Italy10 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, 40138
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola(FC), Emilia-Romagna, 47014
Istituto Europeo di Oncologia IRCCS
Milan, 20141
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
Istituto Oncologico Veneto IRCCS
Padova, 35128
Clinical Trial Center S.p.A
Roma, 00168
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Rome, Lazio, 00168
Istituto Nazionale Tumori Regina Elena
Rome, ROMA, 00144
Ospedale Isola Tiberina - Gemelli Isola
Rome, ROMA, 00186
United Kingdom9 sites
University Hospital Coventry & Warwickshire
Coventry, Warwickshire, CV2 2DX
The Royal Surrey County Hospital
Guildford, GU2 7XX
The Princess Alexandra Hospital NHS Trust
Harlow, England, CM20 1QX
Royal Marsden NHS Foundation Trust
London, SW3 6JJ
Maidstone Hospital
Maidstone, KENT, ME16 9QQ
The Christie NHS Foundation Trust
Manchester, M20 4BX
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA
The Royal Cornwall Hospital
Truro, England, TR1 3LJ
Taiwan8 sites
Taichung Veterans General Hospital
Taichung, 407
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 10002
Mackay Memorial Hospital
Taipei, 10449
Taipei Veterans General Hospital
Taipei, 11217
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan City, 333
National Taiwan University Hospital - Hsinchu branch
Zhubei, Hsinchu, 302
Switzerland7 sites
Tumor Zentrum Aarau
Aarau, 5000
University Hospital Basel
Basel, Canton of Basel-City, 4031
Inselspital Bern
Bern, Canton of Bern, 3010
Kantonsspital Graubünden
Chur, 7000
Kantonsspital Frauenfeld - Spital Thurgau AG
Frauenfeld, Thurgau, 8500
Kantonsspital Münsterlingen - Spital Thurgau AG
Münsterlingen, 8596
Kantonsspital Winterthur
Winterthur, 8401
Australia6 sites
Rosebud Hospital
Capel Sound, Victoria, 3940
Townsville University Hospital
Douglas, Queensland, 4814
Frankston Hospital
Frankston, Victoria, 3199
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Royal Melbourne Hospital
Parkville, Victoria, 3052
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Bulgaria6 sites
Complex Oncology Center - Burgas
Burgas, 8000
Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD
Gabrovo, 5300
Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4004
Multiprofile Hospital for Active Treatment Serdikamed EOOD
Sofia, 1303
MHAT for Women's Health Nadezhda
Sofia, 1330
University Specialized Hospital for Active Treatment of Oncology EAD
Sofia, 1756
Canada6 sites
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick, E3B 5N5
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Germany6 sites
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony, 01307
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
Dresden, 01307
Universitaetsklinikum Erlangen
Erlangen, Bavaria, 91054
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum
Ravensburg, Baden-Wurttemberg, 88212
MVZ für Hämatologie und Onkologie
Velbert, 42551
Poland6 sites
Białostockie Centrum Onkologii im. M. Skłodowskiej-Curie w Białymstoku
Bialystok, Podlaskie Voivodeship, 15-027
Szpitale Pomorskie Sp. z o. o.
Gdynia, Pomeranian Voivodeship, 81-519
Szpital Wojewódzki im. Mikolaja Kopernika w Koszalinie
Koszalin, 75-581
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, Lesser Poland Voivodeship, 30-348
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, 30-727
Instytut MSF Sp zoo
Lodz, Łódź Voivodeship, 90-302
Argentina5 sites
Centro Medico Fleischer
Buenos Aires, 1414
Fundación Respirar
Buenos Aires, C1426ABP
Organizacion Medica de Investigacion
CABA, Buenos Aires, C1015ABO
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja, F5300COE
COE (Centro Oncológico de Excelencia)
San Juan, 5400
Belgium5 sites
Institut Jules Bordet
Anderlecht, Bruxelles-capitale, Région de, 1070
Antwerp University Hospital
Edegem, Antwerpen, 2650
AZ Maria Middelares
Ghent, Oost-vlaanderen, 9000
Grand Hôpital de Charleroi
Gilly, Hainaut, 6060
UZ Leuven
Leuven, Vlaams-brabant, 3000
Czechia5 sites
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, 625 00
Masarykuv onkologicky ustav
Brno, Brno-město, 656 53
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín, 741 01
Fakultni Thomayerova nemocnice
Prague, Praha 4, 14059
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34
Denmark5 sites
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, 8200
Rigshospitalet
Copenhagen, Capital Region, 2100
Esbjerg sygehus, Syddansk Universitetshospital
Esbjerg, Region Syddanmark, 6700
Odense Universitetshospital
Odense, Region Syddanmark, 5000
Sygehus Soenderjylland
Sønderborg, Region Syddanmark, 6400
Hungary5 sites
Országos Onkológiai Intézet
Budapest, 1122
Budapesti Uzsoki Utcai Kórház
Budapest, 1145
Békés Vármegyei Központi Kórház Pándy Kálmán Tagkórház
Gyula, Bekes County, 5700
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, Borsod-Abauj Zemplen county, 3526
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400
Israel5 sites
Rambam Health Care Campus
Haifa, Northern District, 3109601
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001
Rabin Medical Center
Petah Tikva, Central District, 4941492
Sheba Medical Center
Ramat Gan, Central District, 5265601
Sourasky Medical Center
Tel Aviv, TELL ABĪB, 6423906
Slovakia5 sites
Onkologicky Ustav sv. Alzbety
Bratislava, Bratislava Region, 812 50
Narodny onkologicky ustav
Bratislava, Bratislava Region, 833 10
Nemocnica AGEL Komarno
Komárno, Nitra Region, 945 05
Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s.
Michalovce, Košice Region, 071 01
Fakultna nemocnica Trnava
Trnava, Trnava Region, 917 75
Sweden5 sites
Gävle Sjukhus
Gävle, Gävleborgs LÄN [se-21], 81087
Lanssjukhuset Ryhov
Jönköping, 553 05
Södersjukhuset
Stockholm, Stockholms LÄN [se-01], 11883
Akademiska sjukhuset
Uppsala, Uppsala LÄN [se-03], 751 85
Västmanlands Sjukhus Västerås
Västerås, Västmanlands LÄN [se-19], 721 89
Finland4 sites
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, Uusimaa, 00029
Satakunnan Keskussairaala
Pori, 28500
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, 33520
Turku University Hospital
Turku, Southwest Finland, 20520
Ireland4 sites
St. Vincent's University Hospital
Dublin, D04 N2E0
Mater Misericordiae University Hospital
Dublin, D07 A8NN
St. James's Hospital
Dublin, D08 E9P6
Beaumont Hospital, Dublin
Dublin, D9
Greece2 sites
AGIOS SAVVAS General Anticancer Oncological Hospital
Athens, Attikí, 115 22
Aretaieio Hospital
Athens, 115 28
Netherlands2 sites
Meander Medisch Centrum
Amersfoort, Utrecht, 3813 TZ
Amphia Ziekenhuis, locatie Breda Molengracht
Breda, North Brabant, 4818 CK
About this study
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)
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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- PF-07220060, letrozole, abemaciclib, palbociclib, ribociclib
- Keywords
- Locally advanced or metastatic breast cancer, Estrogen receptor positive [ER(+)], Progesterone receptor positive [PR(+)], Hormone receptor positive [HR(+)], Human epidermal growth factor receptor 2 negative [HER2(-)], ER(+)/HER2(-), PR(+)/HER2(-), HR(+)/HER2(-), Advanced Breast Cancer, Breast tumor, Breast cancer, Palbociclib, Abemaciclib, Ribociclib, Partial Response+ (PR+), Metastatic breast cancer, Hormone Therapy, Hormone positive breast cancer, Recurrent breast cancer, HR+
- Medical subject headings
- Breast Neoplasms, Recurrence, Unilateral Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07220060Drug
CDK4 inhibitor
letrozoleDrug
endocrine therapy
abemaciclibDrug
CDK4/6 inhibitor
palbociclibDrug
CDK4/6 inhibitor
ribociclibDrug
CDK4/6 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | PF-07220060 tablet taken by mouth plus Letrozole tablet taken by mouth Receives: Drug: PF-07220060; Drug: letrozole |
| Arm B | Active comparator | Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth Receives: Drug: letrozole; Drug: abemaciclib; Drug: palbociclib; Drug: ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) by BICR
Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause, whichever occurs first
Measured: From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)
Secondary outcomes (11)
Overall Survival (OS)
Time from the date of randomization to the date of death due to any cause
Measured: From the date of randomization until death due to any cause (up to approximately 13 years).
Progression Free Survival (PFS) by Investigator
Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by investigator per RECIST v1.1, or death due to any cause, whichever occurs first
Measured: From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)
OR by BICR and by investigator
Time from randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death whichever occurs first
Measured: From randomization to progression or death whichever occurs first (up to approximately 4 years)
Duration of Response (DoR) by BICR and by investigator
Time from the date of CR or PR to the first documentation of objective progressive disease, or death due to any cause, whichever occurs first
Measured: From the date of CR or PR until objective progressive disease, or death (up to approximately 4 years)
Incidence of treatment emergent treatment related adverse events (AE)
Incidence and severity of AEs graded according to the NCI CTCAE v5.0
Measured: Duration of the study approximately up to 13 years.
Incidence of treatment emergent treatment related serious adverse events
Incidence and severity of AEs graded according to NCI CTCAE v5.0
Measured: Duration of the study approximately up to 13 years.
Estimated mean change from baseline in EORTC QLQ C30
Measured: Baseline to end of treatment (up to approximately 4 years)
Estimated mean change from baseline in BPI-SF
Measured: Baseline to end of treatment (up to approximately 4 years)
Estimated mean change from baseline in EQ-5D-5L
Measured: Baseline to end of treatment (up to approximately 4 years)
Estimated mean change from baseline in EORTC Breast Cancer Module (BR42)
Measured: Baseline to end of treatment (up to approximately 4 years)
Mean change from baseline of ctDNA
Measured: Baseline to end of treatment (up to approximately 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start6 Jan 2025
- Primary completion2 Jan 2029 (estimated)
- Study completion29 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be randomly assigned into 1 of 2 groups in parallel for the entire duration of the study. The experimental arm will receive PF-07220060 and letrozole (Arm A) while the comparator arm with receive the study doctors choice of CDK4/6i and letrozole (Arm B).
- Masking
- None (open label)
- Enrolment
- 1,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760637
- Sponsor's protocol ID
- C4391024
- Other IDs
- 2024-512925-95-00
- Acronym
- FourLight-3
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.