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An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy

Status: Recruiting
Location: See all (150) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to learn about the safety and effects of the study medicine PF-07248144 when given along with fulvestrant for the possible treatment of HR-positive, HER2-negative advanced or metastatic breast cancer. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Confirmed diagnosis of HR-positive HER2-negative breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.

• 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.

Locations
United States
Arkansas
Highlands Oncology Group, PA
NOT_YET_RECRUITING
Springdale
Arizona
Ironwood Cancer & Research Centers
RECRUITING
Chandler
Ironwood Cancer & Research Centers
RECRUITING
Gilbert
Ironwood Cancer & Research Centers
RECRUITING
Glendale
Ironwood Cancer & Research Centers
RECRUITING
Goodyear
Ironwood Cancer & Research Centers
RECRUITING
Mesa
Ironwood Cancer & Research Centers
RECRUITING
Mesa
Ironwood Cancer & Research Centers
RECRUITING
Phoenix
Ironwood Cancer & Research Centers
RECRUITING
Scottsdale
California
Los Angeles Cancer Network - Anaheim
NOT_YET_RECRUITING
Anaheim
Los Angeles Cancer Network - Fountain Valley
NOT_YET_RECRUITING
Fountain Valley
Los Angeles Cancer Network - (Admin Only / Central IDS) - No Patients
NOT_YET_RECRUITING
Glendale
Los Angeles Cancer Network - Van Nuys
NOT_YET_RECRUITING
Los Angeles
Los Angeles Hematology Oncology Medical Group
NOT_YET_RECRUITING
Los Angeles
Clinical and Translational Research Unit (CTRU)
NOT_YET_RECRUITING
Palo Alto
Stanford Cancer Center
NOT_YET_RECRUITING
Palo Alto
Stanford Women's Cancer Center
NOT_YET_RECRUITING
Palo Alto
Connecticut
Smilow Cancer Hospital - Derby
NOT_YET_RECRUITING
Derby
Smilow Cancer Hospital - Fairfield
NOT_YET_RECRUITING
Fairfield
Smilow Cancer Hospital - Glastonbury
NOT_YET_RECRUITING
Glastonbury
Smilow Cancer Hospital - Greenwich
NOT_YET_RECRUITING
Greenwich
Smilow Cancer Hospital - Guilford
NOT_YET_RECRUITING
Guilford
Smilow Cancer Hospital at Saint Francis
NOT_YET_RECRUITING
Hartford
Smilow Cancer Hospital - Yale New Haven Health
NOT_YET_RECRUITING
New Haven
Yale-New Haven Hospital
NOT_YET_RECRUITING
New Haven
Smilow Cancer Hospital - North Haven
NOT_YET_RECRUITING
North Haven
Smilow Cancer Hospital - Long Ridge
NOT_YET_RECRUITING
Stamford
Smilow Cancer Hospital - Torrington
NOT_YET_RECRUITING
Torrington
Smilow Cancer Hospital - Trumbull
NOT_YET_RECRUITING
Trumbull
Smilow Cancer Hospital - Waterbury
NOT_YET_RECRUITING
Waterbury
Smilow Cancer Hospital - Waterford
NOT_YET_RECRUITING
Waterford
Washington, D.c.
MedStar Washington Hospital Center
NOT_YET_RECRUITING
Washington D.c.
Georgia
Summit Cancer Care
RECRUITING
Savannah
Summit Cancer Care, PC
RECRUITING
Savannah
Illinois
Prime Saint Francis-Infusion Services Evanston
NOT_YET_RECRUITING
Evanston
Memorial Hospital.
NOT_YET_RECRUITING
Shiloh
Siteman Cancer Center - Shiloh
NOT_YET_RECRUITING
Shiloh
Orchard Healthcare Research Inc.
NOT_YET_RECRUITING
Skokie
Prime Saint Francis-Infusion Services Skokie
NOT_YET_RECRUITING
Skokie
Maryland
Mercy Medical Center - Baltimore
RECRUITING
Baltimore
Michigan
The Cancer & Hematology Centers
RECRUITING
Big Rapids
The Cancer & Hematology Centers
RECRUITING
Grand Rapids
The Cancer & Hematology Centers
RECRUITING
Grand Rapids
The Cancer & Hematology Centers
RECRUITING
Holland
The Cancer & Hematology Centers
RECRUITING
Norton Shores
Missouri
Siteman Cancer Center - St Peters
NOT_YET_RECRUITING
City Of Saint Peters
Siteman Cancer Center - West County
NOT_YET_RECRUITING
Creve Coeur
Siteman Cancer Center - North County
NOT_YET_RECRUITING
Florissant
Barnes-Jewish Hospital
NOT_YET_RECRUITING
St Louis
Siteman Cancer Center
NOT_YET_RECRUITING
St Louis
Siteman Cancer Center - South County
NOT_YET_RECRUITING
St Louis
Washington University School of Medicine - Siteman Cancer Center
NOT_YET_RECRUITING
St Louis
Nevada
Comprehensive Cancer Centers of Nevada
NOT_YET_RECRUITING
Henderson
Comprehensive Cancer Centers of Nevada
NOT_YET_RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada
NOT_YET_RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada
NOT_YET_RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada
NOT_YET_RECRUITING
Las Vegas
Texas
MD Anderson The Woodlands
NOT_YET_RECRUITING
Conroe
MD Anderson West Houston
NOT_YET_RECRUITING
Houston
The University of Texas M. D. Anderson Cancer Center
NOT_YET_RECRUITING
Houston
University of Texas MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
MD Anderson League City
NOT_YET_RECRUITING
League City
MD Anderson in Sugar Land
NOT_YET_RECRUITING
Sugar Land
Other Locations
Australia
Cancer Research SA Pty Ltd
NOT_YET_RECRUITING
Adelaide
ICON Cancer Centre - Kurralta Park
NOT_YET_RECRUITING
Kurralta Park
Peter MacCallum Cancer Centre
NOT_YET_RECRUITING
Melbourne
Western Health-Sunshine & Footscray Hospitals
NOT_YET_RECRUITING
St Albans
Belgium
Institut Jules Bordet
NOT_YET_RECRUITING
Anderlecht
Algemeen Ziekenhuis klina
NOT_YET_RECRUITING
Brasschaat
AZ Groeninge Campus Kennedylaan
NOT_YET_RECRUITING
Kortrijk
UZ Leuven
RECRUITING
Leuven
Bulgaria
Complex Oncology Center - Burgas
NOT_YET_RECRUITING
Burgas
Specialized Hospital for Active Treatment of Oncology - Haskovo
NOT_YET_RECRUITING
Haskovo
Complex Oncology Center - Plovdiv EOOD
RECRUITING
Plovdiv
Complex Oncology Center - Shumen
NOT_YET_RECRUITING
Shumen
MHAT for Women's Health Nadezhda
NOT_YET_RECRUITING
Sofia
Multiprofile Hospital for Active Treatment Serdikamed EOOD
NOT_YET_RECRUITING
Sofia
Canada
Jewish General Hospital
NOT_YET_RECRUITING
Montreal
CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
RECRUITING
Québec
China
The 2nd Affiliated Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
Fujian Medical University Union Hospital
NOT_YET_RECRUITING
Fuzhou
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING
Guangzhou
Southern Medical University Nanfang Hospital
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The Second Affiliated hospital of Zhejiang University school of medicine
NOT_YET_RECRUITING
Hangzhou
Nanchang People's Hospital
NOT_YET_RECRUITING
Nanchang
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
Finland
Docrates Syöpäsairaala
NOT_YET_RECRUITING
Helsinki
Greece
IASO General Clinic
NOT_YET_RECRUITING
Athens
University General Hospital of Larissa
NOT_YET_RECRUITING
Larissa
Hygeia Hospital
NOT_YET_RECRUITING
Marousi
European Interbalkan Medical Center
NOT_YET_RECRUITING
Thessaloniki
India
Spandana Oncology Centre (SOC)
NOT_YET_RECRUITING
Bengaluru
Artemis hospital
NOT_YET_RECRUITING
Gurugram
Apex Wellness Hospital
NOT_YET_RECRUITING
Nashik
Nirmal Hospital Pvt Ltd.
NOT_YET_RECRUITING
Surat
Bhakti Vedanta Hospital and Research Institute
NOT_YET_RECRUITING
Thane
Israel
Rambam Health Care Campus
NOT_YET_RECRUITING
Haifa
Shaare Zedek Medical Center
NOT_YET_RECRUITING
Jerusalem
Rabin Medical Center
NOT_YET_RECRUITING
Petah Tikva
Sheba Medical Center
NOT_YET_RECRUITING
Ramat Gan
Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Italy
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno
NOT_YET_RECRUITING
Livorno
Istituto Europeo di Oncologia IRCCS
NOT_YET_RECRUITING
Milan
Japan
Juntendo University Hospital
RECRUITING
Bunkyo-ku
Chiba cancer center
RECRUITING
Chiba
National Cancer Center Hospital
RECRUITING
Chuo-ku
St. Luke's International Hospital
RECRUITING
Chuo-ku
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
Hiroshima City Hospital
RECRUITING
Hiroshima
Tokai University Hospital
RECRUITING
Isehara
The Cancer Institute Hospital of JFCR
RECRUITING
Koto
National Hospital Organization Shikoku Cancer Center
RECRUITING
Matsuyama
Okayama University Hospital
RECRUITING
Okayama
Japan Institute for Health Security National Center for Global Health and Medicine
RECRUITING
Shinjuku-ku
Center Hospital of the National Center for Global Health and Medicine
RECRUITING
Shinjyuku-ku
The University of Osaka Hospital
RECRUITING
Suita
Showa Medical University Hospital
RECRUITING
Tokyo
Kanagawa cancer center
RECRUITING
Yokohama
Netherlands
Tergooi MC
NOT_YET_RECRUITING
Hilversum
St. Antonius Ziekenhuis, locatie Utrecht
NOT_YET_RECRUITING
Utrecht
Poland
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
NOT_YET_RECRUITING
Krakow
Puerto Rico
Ad-Vance Medical Research
RECRUITING
Ponce
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Deagu
Gangnam Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Gangnam-gu
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
NOT_YET_RECRUITING
Seoul
Korea University Anam Hospital
NOT_YET_RECRUITING
Seoul
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Seoul
The Catholic Univ. of Korea Seoul St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
Slovakia
Narodny onkologicky ustav
NOT_YET_RECRUITING
Bratislava
Nemocnica Bory, a.s.
NOT_YET_RECRUITING
Bratislava
Onkologicky Ustav sv. Alzbety
NOT_YET_RECRUITING
Bratislava
Nemocnica AGEL Komarno
NOT_YET_RECRUITING
Komárno
Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s.
NOT_YET_RECRUITING
Michalovce
Spain
CHUAC-Complejo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Hospital Universitario de Jaen
RECRUITING
Jaén
Hospital Universitario Virgen de la Victoria
NOT_YET_RECRUITING
Málaga
Sweden
Sahlgrenska Universitetssjukhuset
RECRUITING
Gothenburg
Södersjukhuset
NOT_YET_RECRUITING
Stockholm
Taiwan
Chi Mei Medical Center
NOT_YET_RECRUITING
Tainan
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan
Koo Foundation Sun Yat-Sen Cancer Center
RECRUITING
Taipei
Mackay Memorial Hospital
RECRUITING
Taipei
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Veterans General Hospital
NOT_YET_RECRUITING
Taipei
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-08-05
Estimated Completion Date: 2030-11-04
Participants
Target number of participants: 400
Treatments
Experimental: Arm A: PF-07248144 plus fulvestrant
PF-07248144 tablet taken by mouth plus fulvestrant taken as a shot into the muscle.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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