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ACTIVE NOT RECRUITING

NCT06105632

PHASE2

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

View on ClinicalTrials.gov

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

2026-02-13

Healthy Volunteers

Conditions

Advanced or Metastatic Breast Cancer

Interventions

DRUG

PF-07220060 CDK4 inhibitor

Experimental

DRUG

Fulvestrant

Experimental and Active comparator

DRUG

Everolimus

Active Comparator

DRUG

Exemestane

Active Comparator

Locations (128)

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

Keck Medical Center of USC Pasadena

Pasadena, California, United States

Danbury Hospital

Danbury, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Intermountain Health St. Vincent Regional Hospital

Billings, Montana, United States

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana

Billings, Montana, United States

Cancer Care Specialists

Reno, Nevada, United States

Vassar Brothers Medical Center

Poughkeepsie, New York, United States

Memorial Hermann Cancer Center

Houston, Texas, United States

Baylor Scott & White Medical Center - Round Rock

Round Rock, Texas, United States

Centro de Investigaciones Medicas y Desarrollo LC

Buenos Aires, Buenos Aires F.D., Argentina

CIPREC

Buenos Aires, Buenos Aires F.D., Argentina

Organizacion Medica de Investigacion

CABA, 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

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

Fundación Respirar

Ciudad Autónoma Buenos Aires, Argentina

Clínica Universitaria Reina Fabiola

Córdoba, Argentina

Fundación CORI para la Investigación y Prevención del Cáncer

La Rioja, Argentina

COE (Centro Oncológico de Excelencia)

San Juan, Argentina

Sanatorio Norte

Santiago del Estero, Argentina

Macquarie University

North Ryde, New South Wales, Australia

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

ONCOSITE - Centro de Pesquisa Clinica em Oncologia

Ijuí, Rio Grande do Sul, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Centro de Oncologia - CEON+ - Unidade São Caetano do Sul

São Caetano do Sul, São Paulo, Brazil

Hospital Esperança Recife: Pronto Atendimento 24h

Pernambuco, Brazil

Dr. Everett Chalmers Regional Hospital

Fredericton, New Brunswick, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

CIUSSS- saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Beijing Cancer hospital

Beijing, Beijing Municipality, China

The First People's Hospital of Foshan

Foshan, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jilin Province Tumor Hospital

Changchun, Jilin, China

The First Hospital of Jilin University

Changchun, Jilin, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Kiran Hospital - Multi Super Speciality Hospital and Research Center

Surat, Gujarat, India

Spandana Oncology Centre (SOC)

Bangalore, Karnataka, India

Tata Memorial Hospital

Mumbai, Maharashtra, India

Kims Kingsway Hospital

Nagpur, Maharashtra, India

Apex Wellness Hospital

Nashik, Maharashtra, India

Sahyadri Super Speciality Hospital

Pune, Maharashtra, India

Bhakti Vedanta Hospital and Research Institute

Thane, Maharashtra, India

Rajiv Gandhi Cancer Institute And Research Centre

New Delhi, National Capital Territory of Delhi, India

Rabin Medical Center

Petah Tikva, Central District, Israel

Shaare Zedek Medical Center

Jerusalem, Jerusalem, Israel

Rambam Health Care Campus

Haifa, Northern District, Israel

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Gunma Prefectural Cancer Center

Otashi, Gunma, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Osaka International Cancer Institute

Osaka, Osaka, Japan

Osaka University Hospital

Suita, Osaka, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

St. Luke's International Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Chiba cancer center

Chiba, Japan

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Japan

Okayama University Hospital

Okayama, Japan

National Hospital Organization Osaka National Hospital

Osaka, Japan

Boca Clinical Trials Mexico S.C.

Guadajalara, Jalisco, Mexico

Cryptex Investigación Clínica S.A. de C.V.

Cuauhtémoc, Mexico City, Mexico

Mexico Centre for Clinical Research S.A de C.V

Mexico City, Mexico City, Mexico

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

Unidad de Investigación en Salud de Chihuahua, S.C.

Chihuahua City, Mexico

Oaxaca Site Management Organization S.C.

Oaxaca City, Mexico

Instituto Veracruzano en Investigación Clínica S.C.

Veracruz, Mexico

National Cancer Center

Goyang-si, Kyǒnggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

Ajou University Hospital

Suwon, Kyǒnggi-do, South Korea

Pusan National University Hospital

Busan, Pusan-kwangyǒkshi, South Korea

Seoul National University Hospital