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

Last updated: May 20, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Neoplasm Metastasis

Breast Cancer

Cancer

Treatment

ribociclib

PF-07220060

palbociclib

Clinical Study ID

NCT06760637
C4391024
2024-512925-95-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histological confirmation of breast cancer with evidence of locally advanced ormetastatic disease, which is not amenable to surgical resection or radiation therapywith 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 advancedor metastatic disease.

  • Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1

Exclusion

Exclusion Criteria:

  • In visceral crisis at risk of immediately life-threatening complications in theshort term.

  • Current or past history of central nervous system metastases.

  • Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence duringor within 12 months after the last dose of ET.

  • Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12months after the last dose of CDK4/6i.

  • Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

Study Design

Total Participants: 1020
Treatment Group(s): 5
Primary Treatment: ribociclib
Phase: 3
Study Start date:
January 06, 2025
Estimated Completion Date:
December 29, 2037

Connect with a study center

  • Townsville University Hospital

    Douglas, Queensland 4814
    Australia

    Active - Recruiting

  • Rosebud Hospital

    Capel Sound, Victoria 3940
    Australia

    Active - Recruiting

  • Frankston Hospital

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Multiprofile Hospital for Active Treatment Serdika EOOD

    Sofia, Sofia (stolitsa) 1632
    Bulgaria

    Site Not Available

  • Complex Oncology Center - Burgas

    Burgas, 8000
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD

    Gabrovo, 5300
    Bulgaria

    Site Not Available

  • Specialized Hospital for Active Treatment of Oncology - Haskovo

    Haskovo, 6300
    Bulgaria

    Site Not Available

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4004
    Bulgaria

    Active - Recruiting

  • Complex Oncology Center - Shumen

    Shumen, 9700
    Bulgaria

    Site Not Available

  • Dr. Everett Chalmers Regional Hospital

    Fredericton, New Brunswick E3B 5N5
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Beijing Cancer hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • The First People's Hospital of Foshan

    Foshan, Guangdong 528000
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210031
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • The 2nd Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning 116023
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110015
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Linhai, Zhejiang 317000
    China

    Site Not Available

  • Fakultni nemocnice v Motole

    Praha, Praha 5 150 06
    Czechia

    Site Not Available

  • Rigshospitalet

    Copenhagen, Hovedstaden 2100
    Denmark

    Site Not Available

  • Aarhus Universitetshospital, Skejby

    Aarhus, Midtjylland 8200
    Denmark

    Site Not Available

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa 33520
    Finland

    Site Not Available

  • Vaasan Keskussairaala

    Vaasa, Pohjanmaa 65130
    Finland

    Site Not Available

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

    Helsinki, Uusimaa 00029
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku, Varsinais-suomi 20520
    Finland

    Site Not Available

  • CHD Vendee

    La Roche-sur-Yon, Vendée 85000
    France

    Site Not Available

  • InVO Institut für Versorgungsforschung in der Onkologie

    Koblenz, Rheinland-pfalz 56068
    Germany

    Site Not Available

  • Hygeia Hospital

    Marousi, Attikí 151 23
    Greece

    Site Not Available

  • Rajiv Gandhi Cancer Institute And Research Centre

    New Delhi, Delhi 110085
    India

    Site Not Available

  • Nirmal Hospital Pvt Ltd.

    Surat, Gujarat 395002
    India

    Active - Recruiting

  • Artemis hospital

    Gurugram, Haryana 122001
    India

    Site Not Available

  • Spandana Oncology Centre (SOC)

    Bangalore, Karnataka 560069
    India

    Site Not Available

  • Tata Memorial Hospital

    Mumbai, Maharashtra 400012
    India

    Site Not Available

  • Apex Wellness Hospital

    Nashik, Maharashtra 422009
    India

    Active - Recruiting

  • Sahyadri Super Speciality Hospital

    Pune, Maharashtra 411004
    India

    Active - Recruiting

  • Bhakti Vedanta Hospital and Research Institute

    Thane, Maharashtra 401107
    India

    Active - Recruiting

  • Basavatarakam Indo American Cancer Hospital & Research Institute

    Hyderabad, Telangana 500034
    India

    Site Not Available

  • Apollo Multispeciality Hospitals limited

    Kolkata, WEST Bengal 700054
    India

    Site Not Available

  • Rabin Medical Center

    Petah Tikva, Hamerkaz 4941492
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, Hamerkaz 5265601
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, Hatsafon 3109601
    Israel

    Active - Recruiting

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb 6423906
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, Yerushalayim 9112001
    Israel

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, Toscana 50134
    Italy

    Site Not Available

  • Istituto Europeo di Oncologia IRCCS

    Milano, 20141
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100
    Italy

    Site Not Available

  • Nagoya City University Hospital

    Nagoya, Aichi 467-8602
    Japan

    Active - Recruiting

  • Nagoya University Hospital

    Nagoya, Aichi 466-8560
    Japan

    Active - Recruiting

  • Gunma Prefectural Cancer Center

    Otashi, Gunma 373-8550
    Japan

    Active - Recruiting

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido 003-0804
    Japan

    Active - Recruiting

  • Kanagawa cancer center

    Yokohama, Kanagawa 2418515
    Japan

    Active - Recruiting

  • Kyoto University Hospital

    Sakyo-ku, Kyoto 606-8507
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi 980-8574
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita, Osaka 565-0871
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo 135-8550
    Japan

    Active - Recruiting

  • Showa University Hospital

    Shinagawa, Tokyo 142-8666
    Japan

    Active - Recruiting

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-ku, Tokyo 162-8655
    Japan

    Active - Recruiting

  • Chiba Cancer Center

    Chiba, 260-8717
    Japan

    Site Not Available

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395
    Japan

    Site Not Available

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518
    Japan

    Active - Recruiting

  • Kumamoto Shinto General Hospital

    Kumamoto, 862-8655
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006
    Japan

    Active - Recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567
    Japan

    Active - Recruiting

  • Pratia MCM Krakow

    Kraków, Małopolskie 30-727
    Poland

    Site Not Available

  • AIDPORT Sp. z o.o.

    Skórzewo, Wielkopolskie 60-185
    Poland

    Site Not Available

  • Instytut MSF Sp zoo

    Łódź, Łódzkie 91-614
    Poland

    Active - Recruiting

  • Nemocnica AGEL Komarno

    Komarno, Nitriansky KRAJ 945 05
    Slovakia

    Site Not Available

  • Medeon, s.r.o.

    Banka, Trnavský KRAJ 921 01
    Slovakia

    Site Not Available

  • Hospital General Universitario de Elche

    Elche, Alicante 03203
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona] 08035
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Malaga, Málaga 29010
    Spain

    Active - Recruiting

  • Hospital Universitario San Cecilio

    Granada, 18016
    Spain

    Site Not Available

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Sjukhuset I Gävle

    Gävle, Gävleborgs LÄN [se-21] 80187
    Sweden

    Site Not Available

  • Akademiska sjukhuset

    Uppsala, Uppsala LÄN [se-03] 751 85
    Sweden

    Site Not Available

  • Västmanlands Sjukhus Västerås

    Västerås, Västmanlands LÄN [se-19] 721 89
    Sweden

    Site Not Available

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, Västra Götalands LÄN [se-14] 413 45
    Sweden

    Site Not Available

  • Lanssjukhuset Ryhov

    Jönköping, 553 05
    Sweden

    Site Not Available

  • Sundsvalls Sjukhus

    Sundsvall, 856 40
    Sweden

    Site Not Available

  • Kantonsspital Graubünden

    Chur, 7000
    Switzerland

    Site Not Available

  • Kantonsspital Olten

    Olten, 4600
    Switzerland

    Site Not Available

  • National Taiwan University Hospital - Hsinchu branch

    Zhu Bei City, Hsinchu 302
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 407
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital

    Taipei, 10449
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Site Not Available

  • İ.A.Ü VM Medical Park Florya Hastanesi

    Istanbul, İ̇stanbul 34295
    Turkey

    Site Not Available

  • Memorial Ankara Hastanesi

    Ankara, 06520
    Turkey

    Site Not Available

  • Dicle Üniversitesi

    Diyarbakir, 21200
    Turkey

    Active - Recruiting

  • Sarah Cannon Research Institute UK

    London, London, CITY OF w1g 6ad
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Ironwood Cancer & Research Centers

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Ironwood Cancer & Research Centers

    Gilbert, Arizona 85297
    United States

    Active - Recruiting

  • Ironwood Cancer & Research Centers

    Glendale, Arizona 85306
    United States

    Active - Recruiting

  • Ironwood Cancer & Research Centers

    Mesa, Arizona 85206
    United States

    Active - Recruiting

  • Ironwood Cancer & Research Centers

    Phoenix, Arizona 85028
    United States

    Active - Recruiting

  • Ironwood Cancer & Research Centers

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Highlands Oncology

    Fayetteville, Arkansas 72703
    United States

    Active - Recruiting

  • Highlands Oncology

    Rogers, Arkansas 72758
    United States

    Active - Recruiting

  • Highlands Oncology Group

    Springdale, Arkansas 72762
    United States

    Active - Recruiting

  • Cancer and Blood Research Center, LLC

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Cancer and Blood Specialty Clinic / Cancer and Blood Research Center, LLC

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Cancer AND Blood Specialty Clinic

    Torrance, California 90505
    United States

    Site Not Available

  • Intermountain Health Lutheran Hospital

    Golden, Colorado 80401
    United States

    Active - Recruiting

  • Lutheran Hospital - Cancer Centers of Colorado

    Golden, Colorado 80401
    United States

    Active - Recruiting

  • Cancer Centers of Colorado St. Mary's Regional Hospital

    Grand Junction, Colorado 81501
    United States

    Site Not Available

  • Intermountain Health

    Grand Junction, Colorado 81505
    United States

    Site Not Available

  • Intermountain Health Saint Mary's Regional Hospital

    Grand Junction, Colorado 81501
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • AdventHealth Altamonte Infusion Center

    Altamonte Springs, Florida 32701
    United States

    Active - Recruiting

  • AdventHealth Altamonte Springs

    Altamonte Springs, Florida 32701
    United States

    Active - Recruiting

  • AdventHealth Medical Group Altamonte

    Altamonte Springs, Florida 32701
    United States

    Active - Recruiting

  • Mount Sinai Medical Center, Aventura

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Mount Sinai Medical Center

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • AdventHealth Medical Group Orlando

    Orlando, Florida 32804
    United States

    Active - Recruiting

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • AdventHealth Orlando Infusion Center

    Orlando, Florida 32804
    United States

    Active - Recruiting

  • Summit Cancer Care, PC

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • Endeavor Health

    Elmhurst, Illinois 60126
    United States

    Active - Recruiting

  • Ascension Illinois - Evanston Infusion Center

    Evanston, Illinois 60202
    United States

    Active - Recruiting

  • Endeavor Health

    Naperville, Illinois 60540
    United States

    Active - Recruiting

  • Ascension Illinois-Skokie Infusion Center

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Orchard Healthcare Research Inc.

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Annapolis, Maryland 21401
    United States

    Active - Recruiting

  • Mercy Medical Center - Baltimore

    Baltimore, Maryland 21202
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Dana-Farber Cancer Institute - Chestnut Hill

    Newton, Massachusetts 02459
    United States

    Site Not Available

  • Allina Health Cancer Institute - Mercy Hospital

    Coon Rapids, Minnesota 55433
    United States

    Site Not Available

  • Allina Health Cancer Institute - Abbott Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Allina Health Cancer Institute - United Hospital

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana 59715
    United States

    Active - Recruiting

  • Renown Health

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Renown Regional Medical Center

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Providence Investigational Drug Service - Westside

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Providence Oncology and Hematology Care Clinic - Westside

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Providence Portland Medical Center Investigational Drug Services

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Tyler on behalf of UT Health East Texas HOPE Cancer

    Tyler, Texas 75708
    United States

    Active - Recruiting

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