Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment
Sponsor: Pfizer
Summary
The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body. This study is seeking female and male participants who: * are 18 years of age or older; * are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; * have advanced or metastatic breast cancer after taking other treatments before this study; * have not taken or need to take medications that are not allowed by the study protocol; * do not have any medical or mental conditions that may increase the risk of study participation. Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor's choice of treatment which can either be: * Fulvestrant alone taken as shot into the muscle. * Everolimus along with exemestane taken once daily by mouth. This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor's choice of treatment. This will help decide if the study medicine is safe and effective. Participants will receive study treatment and/or will be in the study until: * imaging scans (such as an MRI and/or CT) show that their cancer is getting worse. * the study doctor thinks the participant is no longer benefitting from the study medicine. * has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. * the participant chooses to stop taking part.
Official title: AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 2 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS AT LEAST 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY (FOURLIGHT-1)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
333
Start Date
2024-01-09
Completion Date
2028-01-21
Last Updated
2026-08-20
Healthy Volunteers
No
Conditions
Interventions
PF-07220060 CDK4 inhibitor
Experimental
Fulvestrant
Experimental and Active comparator
Everolimus
Active Comparator
Exemestane
Active Comparator
Locations (48)
Hoag Health Center Irvine
Irvine, California, United States
Hoag Hospital Irvine
Irvine, California, United States
Keck Hospital of USC
Los Angeles, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Intermountain Health St. Vincent Regional Hospital
Billings, Montana, United States
Memorial Hermann Cancer Center
Houston, Texas, United States
CIPREC
Buenos Aires, Buenos Aires F.D., Argentina
Clinica Viedma S. A
Viedma, Río Negro Province, Argentina
Instituto de Oncología de Rosario
Rosario, Santa Fe Province, Argentina
Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
San Miguel de Tucumán, Tucumán Province, Argentina
Clínica Universitaria Reina Fabiola
Córdoba, Argentina
Icon Cancer Centre Townsville
Rosslea, Queensland, Australia
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Pernambuco
Recife, Pernambuco, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Sahyadri Super Speciality Hospital
Pune, Maharashtra, India
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, India
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Rambam Health Care Campus
Haifa, Northern District, Israel
Gunma Prefectural Cancer Center
Otashi, Gunma, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Osaka University Hospital
Suita, Osaka, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, Japan
Chiba cancer center
Chiba, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
COI Centro Oncologico Internacional S.A.P.I. de C.V.
Mexico City, Mexico City, Mexico
Filios Alta Medicina S.A. de C.V.
Monterrey, Nuevo León, Mexico
Oaxaca Site Management Organization S.C.
Oaxaca City, Mexico
Instituto Veracruzano en Investigación Clínica S.C.
Veracruz, Mexico
Ajou University Hospital
Suwon, Kyǒnggi-do, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan
Medipol Mega Universite Hastanesi
Stanbul, İ̇stanbul, Turkey (Türkiye)
Gulhane Egitim Arastirma Hastanesi
Ankara, Turkey (Türkiye)
Ultramar Medical Imaging Center
Ankara, Turkey (Türkiye)
Ultramar Medical Imaging Center
Ankara, Turkey (Türkiye)
Sarah Cannon Research Institute UK
London, London, CITY of, United Kingdom
Imperial College Healthcare NHS Trust, Charing Cross Hospital
London, United Kingdom