A Study to Learn About the Study Medicine Called PF-07248144 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: NCT07062965
Last Updated: 2025-12-19
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2025-08-05
2030-11-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
HR-positive breast cancer cells have proteins on their surface called receptors that bind to hormones like estrogen and progesterone (female sex hormones). These hormones can promote the growth of cancer cells.
HER2-negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2-negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface.
Advanced cancer is a term that is often used to describe cancer that is unlikely to be cured.
Metastatic cancer is the type where the cancer cells spread from one part of the body to another.
This study is seeking for participants whose breast cancer has gotten worsen after receiving cyclin dependent kinase (CDK) 4/6 inhibitor-based therapy.
Half of participants in this study will receive their usual study treatment, everolimus with endocrine therapy (either exemestane or fulvestrant) for HR-positive/HER2-negative advanced or metastatic breast cancer (A/mBC). The study doctor will discuss which hormone therapy is right for the participant before treatment begins.
PF-07248144 is a tablet that will be taken by mouth at home every day in a 28-day cycle. Fulvestrant will be given as two injections (one injection in the buttock) at visits to the study clinic. Everolimus and exemestane are also tablets and will be taken by mouth at home every day in a 28-day cycle.
The study will compare the experiences of people receiving PF-07248144 in combination with fulvestrant to those of the people who do not. This will help see if PF-07248144 in combination with fulvestrant is safe and effective.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A: PF-07248144 plus fulvestrant
PF-07248144 tablet taken by mouth plus fulvestrant taken as a shot into the muscle.
PF-07248144
KAT6 inhibitor
Fulvestrant
Endocrine therapy
Arm B: everolimus plus ET
Everolimus tablet taken by mouth plus investigator's choice of endocrine therapy of exemestane tablet taken by mouth or fulvestrant taken as a shot into the muscle.
Fulvestrant
Endocrine therapy
Everolimus
mTOR inhibitor
Exemestane
Endocrine therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PF-07248144
KAT6 inhibitor
Fulvestrant
Endocrine therapy
Everolimus
mTOR inhibitor
Exemestane
Endocrine therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Prior CDK4/6 inhibitor therapy in combination with endocrine therapy in advance metastatic setting or in adjuvant setting with documented progression during or within 12 months after the last dose of CDK4/6i.
* Participants are eligible if they previously received CDK4/6i or ET as a monotherapy, or in combination for rechallenge therapy in the advance or metastatic setting; have received prior therapy targeting estrogen receptor 1 (ESR1) or breast cancer gene (BRCA)1/2.
* Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
Exclusion Criteria
* Received greater than two prior lines of systemic therapy in the advance or metastatic setting
* Had received any prior chemotherapy, including antibody drug conjugates (ADCs), in advance or metastatic setting. Participants who have previously received chemotherapy in the (neo)adjuvant setting are not excluded from the study.
* Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
* Renal impairment, hepatic dysfunction, or hematologic abnormalities.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Ironwood Cancer & Research Centers
Gilbert, Arizona, United States
Ironwood Cancer & Research Centers
Glendale, Arizona, United States
Ironwood Cancer & Research Centers
Goodyear, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Phoenix, Arizona, United States
Ironwood Cancer & Research Centers
Scottsdale, Arizona, United States
Highlands Oncology Group, PA
Springdale, Arkansas, United States
Los Angeles Cancer Network - Anaheim
Anaheim, California, United States
Los Angeles Cancer Network - Fountain Valley
Fountain Valley, California, United States
Los Angeles Cancer Network - (Admin Only / Central IDS) - No Patients
Glendale, California, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States
Los Angeles Cancer Network - Van Nuys
Los Angeles, California, United States
Clinical and Translational Research Unit (CTRU)
Palo Alto, California, United States
Stanford Cancer Center
Palo Alto, California, United States
Stanford Women's Cancer Center
Palo Alto, California, United States
Smilow Cancer Hospital - Derby
Derby, Connecticut, United States
Smilow Cancer Hospital - Fairfield
Fairfield, Connecticut, United States
Smilow Cancer Hospital - Glastonbury
Glastonbury, Connecticut, United States
Smilow Cancer Hospital - Greenwich
Greenwich, Connecticut, United States
Smilow Cancer Hospital - Guilford
Guilford, Connecticut, United States
Smilow Cancer Hospital at Saint Francis
Hartford, Connecticut, United States
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
Smilow Cancer Hospital - North Haven
North Haven, Connecticut, United States
Smilow Cancer Hospital - Long Ridge
Stamford, Connecticut, United States
Smilow Cancer Hospital - Torrington
Torrington, Connecticut, United States
Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut, United States
Smilow Cancer Hospital - Waterbury
Waterbury, Connecticut, United States
Smilow Cancer Hospital - Waterford
Waterford, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Summit Cancer Care, PC
Savannah, Georgia, United States
Summit Cancer Care
Savannah, Georgia, United States
Prime Saint Francis-Infusion Services Evanston
Evanston, Illinois, United States
Memorial Hospital.
Shiloh, Illinois, United States
Siteman Cancer Center - Shiloh
Shiloh, Illinois, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, United States
Prime Saint Francis-Infusion Services Skokie
Skokie, Illinois, United States
Mercy Medical Center - Baltimore
Baltimore, Maryland, United States
The Cancer & Hematology Centers
Big Rapids, Michigan, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, United States
The Cancer & Hematology Centers
Holland, Michigan, United States
The Cancer & Hematology Centers
Norton Shores, Michigan, United States
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States
Siteman Cancer Center - North County
Florissant, Missouri, United States
Siteman Cancer Center
St Louis, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
MD Anderson The Woodlands
Conroe, Texas, United States
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
MD Anderson West Houston
Houston, Texas, United States
MD Anderson League City
League City, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
Cancer Research SA Pty Ltd
Adelaide, South Australia, Australia
ICON Cancer Centre - Kurralta Park
Kurralta Park, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Western Health-Sunshine & Footscray Hospitals
St Albans, Victoria, Australia
Algemeen Ziekenhuis klina
Brasschaat, Antwerpen, Belgium
Institut Jules Bordet
Anderlecht, Bruxelles-capitale, Région de, Belgium
UZ Leuven
Leuven, Vlaams-brabant, Belgium
AZ Groeninge Campus Kennedylaan
Kortrijk, West-vlaanderen, Belgium
Multiprofile Hospital for Active Treatment Serdikamed EOOD
Sofia, Sofia (stolitsa), Bulgaria
Complex Oncology Center - Burgas
Burgas, , Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, , Bulgaria
Complex Oncology Center - Plovdiv EOOD
Plovdiv, , Bulgaria
Complex Oncology Center - Shumen
Shumen, , Bulgaria
MHAT for Women's Health Nadezhda
Sofia, , Bulgaria
Jewish General Hospital
Montreal, Quebec, Canada
CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
Québec, Quebec, Canada
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Nanchang People's Hospital
Nanchang, Jiangxi, China
The 2nd Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou, Zhejiang, China
Fakultni Thomayerova nemocnice
Prague, Praha 4, Czechia
Fakultni nemocnice v Motole
Prague, Praha 5, Czechia
Fakultni nemocnice Bulovka
Prague, Praha 8, Czechia
Docrates Syöpäsairaala
Helsinki, Uusimaa, Finland
IASO General Clinic
Athens, Attica, Greece
Hygeia Hospital
Marousi, Attikí, Greece
European Interbalkan Medical Center
Thessaloniki, Thessaloníki, Greece
University General Hospital of Larissa
Larissa, Thessalía, Greece
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, India
Artemis hospital
Gurugram, Haryana, India
Spandana Oncology Centre (SOC)
Bengaluru, Karnataka, India
Apex Wellness Hospital
Nashik, Maharashtra, India
Bhakti Vedanta Hospital and Research Institute
Thane, Maharashtra, India
Rabin Medical Center
Petah Tikva, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Rambam Health Care Campus
Haifa, Northern District, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, Israel
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno
Livorno, Tuscany, Italy
Istituto Europeo di Oncologia IRCCS
Milan, , Italy
Chiba cancer center
Chiba, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Kanagawa cancer center
Yokohama, Kanagawa, Japan
The University of Osaka Hospital
Suita, Osaka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto, Tokyo, Japan
Japan Institute for Health Security National Center for Global Health and Medicine
Shinjuku-ku, Tokyo, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjyuku-ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Hiroshima City Hospital
Hiroshima, , Japan
Okayama University Hospital
Okayama, , Japan
Showa Medical University Hospital
Tokyo, , Japan
Tergooi MC
Hilversum, North Holland, Netherlands
St. Antonius Ziekenhuis, locatie Utrecht
Utrecht, , Netherlands
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, Lesser Poland Voivodeship, Poland
Ad-Vance Medical Research
Ponce, , Puerto Rico
Onkologicky Ustav sv. Alzbety
Bratislava, Bratislava Region, Slovakia
Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s.
Michalovce, Košice Region, Slovakia
Nemocnica AGEL Komarno
Komárno, Nitra Region, Slovakia
Narodny onkologicky ustav
Bratislava, , Slovakia
Nemocnica Bory, a.s.
Bratislava, , Slovakia
Seoul National University Bundang Hospital
Seongnam-si, Kyǒnggi-do, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, Seoul-teukbyeolsi [seoul], South Korea
Korea University Anam Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Kyungpook National University Chilgok Hospital
Deagu, Taegu-kwangyǒkshi, South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña], Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Hospital Universitario de Jaen
Jaén, , Spain
Södersjukhuset
Stockholm, Stockholms LÄN [se-01], Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands LÄN [se-14], Sweden
Chi Mei Medical Center
Tainan, Tainan, 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-520566-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4551002
Identifier Type: -
Identifier Source: org_study_id