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
NCT ID: NCT06105632
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
333 participants
INTERVENTIONAL
2024-01-09
2028-01-21
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
PF-07220060 to be taken by mouth as a tablet in combination with fulvestrant (a solution for injection)
PF-07220060 CDK4 inhibitor
Experimental
Fulvestrant
Experimental and Active comparator
Arm B
Investigator's choice of therapy of either:
* Fulvestrant alone (a solution for injection), or
* Everolimus in combination with exemestane, both a tablet to be taken by mouth.
Fulvestrant
Experimental and Active comparator
Everolimus
Active Comparator
Exemestane
Active Comparator
Interventions
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PF-07220060 CDK4 inhibitor
Experimental
Fulvestrant
Experimental and Active comparator
Everolimus
Active Comparator
Exemestane
Active Comparator
Eligibility Criteria
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Inclusion Criteria
* Documented estrogen receptor (ER) and/or progesterone receptor (PR)- positive tumor
* Documented HER2-negative tumor
* Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.
* Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.
* Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.
Exclusion Criteria
* In visceral crisis at risk of immediately life-threatening complications in the short term.
* Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
* Prior treatment with any of the following:
* Everolimus or investigational anti-cancer agents in any setting
* Prior chemotherapy in the advanced setting
* Radiation within 2 weeks of randomization
* Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 \[CYP3A4/5\] or uridine 5' diphosphate-glucuronosyltransferase 2B7 \[UGT2B7\] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors).
* Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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UCSF - John Muir Health Cancer Center Berkeley
Berkeley, California, United States
Washington Hospital Healthcare System
Fremont, California, United States
Hoag Health Center Irvine
Irvine, California, United States
Hoag Hospital Irvine
Irvine, California, United States
Eisenhower George and Julia Argyros Health Center
La Quinta, 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
Eisenhower Health Center at South Palm Canyon
Palm Springs, California, United States
Keck Medical Center of USC Pasadena
Pasadena, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
UCSF Cancer Center San Mateo
San Mateo, California, United States
Saint Vincent's Medical Center (SVMC)
Bridgeport, Connecticut, United States
Danbury Hospital
Danbury, Connecticut, United States
Hartford Hospital (HH)
Hartford, Connecticut, United States
MidState Medical Center (MMC)
Meriden, Connecticut, United States
Hartford Healthcare
New Britain, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut, Medical Arts Center
Plainville, 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
Northwestern Memorial Hospital
Chicago, Illinois, United States
NorthShore University HealthSystem
Chicago, Illinois, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
NorthShore University HealthSystem
Glenview, Illinois, United States
NorthShore University HealthSystem
Highland Park, Illinois, 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
Aurora Health Center - Southern Lakes
Burlington, Wisconsin, United States
Aurora Medical Centers - Grafton
Grafton, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Aurora Health Center - Kenosha
Kenosha, Wisconsin, United States
Aurora Health Center Milwaukee - Good Hope
Milwaukee, Wisconsin, United States
Aurora St Luke's Medical Center
Milwaukee, Wisconsin, United States
Aurora Medical Center - Summit
Summit, Wisconsin, United States
Aurora Cancer Care
Wauwatosa, Wisconsin, United States
CIPREC
Buenos Aires, Buenos Aires F.D., Argentina
Organizacion Medica de Investigacion
CABA, Buenos Aires F.D., Argentina
Fundación Cenit Para La Investigación En Neurociencias
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
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
Thāne, 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
Chiba cancer center
Chiba, Chiba, 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, Tokyo, 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
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Kangbuk Samsung Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Keimyung University Dongsan Hospital
Daegu, Taegu-kwangyǒkshi, South Korea
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Medipol Mega Universite Hastanesi
Stanbul, İ̇stanbul, Turkey (Türkiye)
Acibadem Altunizade Hospital
Üsküdar / Stanbul, İ̇stanbul, Turkey (Türkiye)
Gulhane Egitim Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara, , Turkey (Türkiye)
Hacettepe Universite Hastaneleri
Ankara, , Turkey (Türkiye)
Ultramar Medical Imaging Center
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Ultramar Medical Imaging Center
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi
Ankara, , Turkey (Türkiye)
Ultramar Medical Imaging Center
Ankara, , Turkey (Türkiye)
Dicle Üniversitesi
Diyarbakır, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi Hastaneleri
Kayseri, , Turkey (Türkiye)
Kocaeli Üniversitesi
Kocaeli, , Turkey (Türkiye)
Necmettin Erbakan Meram Medical Fac.
Konya, , Turkey (Türkiye)
Samsun Medical Park Hastanesi
Samsun, , Turkey (Türkiye)
Imperial College Healthcare NHS Trust, Charing Cross Hospital
London, Hammersmith and Fulham, United Kingdom
Sarah Cannon Research Institute UK
London, London, CITY of, United Kingdom
The Royal Surrey County Hospital
Guildford, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2023-506487-13-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4391022
Identifier Type: -
Identifier Source: org_study_id