Breast Cancer Clinical Trials

Find Breast Cancer Clinical Trials Near You

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 (199) 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
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
Ventura County Hematology Oncology Specialists
NOT_YET_RECRUITING
Camarillo
Los Angeles Cancer Network - (Admin Only / Central IDS) - No Patients
NOT_YET_RECRUITING
Glendale
Los Angeles Cancer Network - Good Samaritan
NOT_YET_RECRUITING
Los Angeles
Los Angeles Hematology Oncology Medical Group
NOT_YET_RECRUITING
Los Angeles
Dr. Manoj Khatore, MD, FACC (Cardiology Practice)
NOT_YET_RECRUITING
Oxnard
Rolling Oaks Radiology - Oxnard
NOT_YET_RECRUITING
Oxnard
Ventura County Hematology Oncology Specialists
NOT_YET_RECRUITING
Oxnard
Ventura County Hematology Oncology Specialists
NOT_YET_RECRUITING
Ventura
Colorado
Rocky Mountain Cancer Centers LLP
NOT_YET_RECRUITING
Aurora
Rocky Mountain Cancer Centers LLP
NOT_YET_RECRUITING
Boulder
Rocky Mountain Cancer Centers LLP
NOT_YET_RECRUITING
Centennial
Rocky Mountain Cancer Centers LLP
NOT_YET_RECRUITING
Colorado Springs
Rocky Mountain Cancer Centers LLP
NOT_YET_RECRUITING
Colorado Springs
Rocky Mountain Cancer Centers LLP
NOT_YET_RECRUITING
Denver
Rocky Mountain Cancer Centers LLP
NOT_YET_RECRUITING
Englewood
Rocky Mountain Cancer Centers LLP
NOT_YET_RECRUITING
Lakewood
Rocky Mountain Cancer Centers LLP
NOT_YET_RECRUITING
Littleton
Rocky Mountain Cancer Centers LLP
NOT_YET_RECRUITING
Lone Tree
Rocky Mountain Cancer Centers LLP
NOT_YET_RECRUITING
Longmont
Rocky Mountain Cancer Centers LLP
NOT_YET_RECRUITING
Pueblo
Rocky Mountain Cancer Centers LLP
NOT_YET_RECRUITING
Thornton
Connecticut
Smilow Cancer Hospital - Derby
RECRUITING
Derby
Smilow Cancer Hospital - Fairfield
RECRUITING
Fairfield
Smilow Cancer Hospital - Glastonbury
RECRUITING
Glastonbury
Smilow Cancer Hospital - Greenwich
RECRUITING
Greenwich
Smilow Cancer Hospital - Guilford
RECRUITING
Guilford
Smilow Cancer Hospital at Saint Francis
RECRUITING
Hartford
Smilow Cancer Hospital - Yale New Haven Health
RECRUITING
New Haven
Smilow Cancer Hospital - North Haven
RECRUITING
North Haven
Smilow Cancer Hospital - Long Ridge
RECRUITING
Stamford
Smilow Cancer Hospital - Waterbury
RECRUITING
Waterbury
Washington, D.c.
MedStar Washington Hospital Center
NOT_YET_RECRUITING
Washington D.c.
Georgia
Emory University Hospital Midtown
RECRUITING
Atlanta
Summit Cancer Care
RECRUITING
Savannah
Summit Cancer Care, PC
RECRUITING
Savannah
Illinois
Memorial Hospital.
RECRUITING
Shiloh
Orchard Healthcare Research Inc.
NOT_YET_RECRUITING
Skokie
Maryland
Maryland Oncology Hematology P.A.
NOT_YET_RECRUITING
Annapolis
Mfsmc-Hjwci
NOT_YET_RECRUITING
Baltimore
Maryland Oncology Hematology P.A.
NOT_YET_RECRUITING
Bethesda
Maryland Oncology Hematology P.A.
NOT_YET_RECRUITING
Columbia
Maryland Oncology Hematology P.A.
NOT_YET_RECRUITING
Germantown
Maryland Oncology Hematology P.A.
NOT_YET_RECRUITING
Largo
Maryland Oncology Hematology P.A.
NOT_YET_RECRUITING
Rockville
Maryland Oncology Hematology P.A.
NOT_YET_RECRUITING
Silver Spring
Michigan
The Cancer & Hematology Centers
RECRUITING
Holland
Minnesota
Minnesota Oncology Hematology, P.A.
NOT_YET_RECRUITING
Burnsville
Minnesota Oncology Hematology, P.A.
NOT_YET_RECRUITING
Coon Rapids
Minnesota Oncology Hematology, P.A.
NOT_YET_RECRUITING
Edina
Minnesota Oncology Hematology, P.A.
NOT_YET_RECRUITING
Maple Grove
Minnesota Oncology Hematology, P.A.
NOT_YET_RECRUITING
Maplewood
Minnesota Oncology Hematology, P.A.
NOT_YET_RECRUITING
Minneapolis
Minnesota Oncology Hematology, P.A.
NOT_YET_RECRUITING
Plymouth
Minnesota Oncology Hematology, P.A.
NOT_YET_RECRUITING
Woodbury
Missouri
Siteman Cancer Center - St Peters
RECRUITING
City Of Saint Peters
Siteman Cancer Center - North County
RECRUITING
Florissant
Saint Luke's Hospital of Kansas City
NOT_YET_RECRUITING
Kansas City
Siteman Cancer Center
RECRUITING
St Louis
New Jersey
Hackensack University Medical Center
NOT_YET_RECRUITING
Hackensack
Nevada
Comprehensive Cancer Centers of Nevada
NOT_YET_RECRUITING
Henderson
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
Tennessee
The West Clinic, PLLC dba West Cancer Center
NOT_YET_RECRUITING
Germantown
Henry-Joyce Cancer Clinic
RECRUITING
Nashville
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology-Northeast Texas
RECRUITING
Allen
Texas Oncology - Central South (Balcones Dr)
RECRUITING
Austin
Texas Oncology - Central South (James Casey)
RECRUITING
Austin
Texas Oncology-Northeast Texas
RECRUITING
Denison
Texas Oncology-Northeast Texas
RECRUITING
Denton
Texas Oncology-Northeast Texas
RECRUITING
Flower Mound
MD Anderson West Houston
RECRUITING
Houston
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
US Oncology Investigational Product Center (IPC)
RECRUITING
Irving
US Oncology Investigational Products Center
RECRUITING
Irving
MD Anderson League City
RECRUITING
League City
Texas Oncology-Northeast Texas
RECRUITING
Lewisville
Texas Oncology-Northeast Texas
RECRUITING
Longview
Texas Oncology - Central South (South 2nd)
RECRUITING
Mcallen
Texas Oncology-Northeast Texas
RECRUITING
Mckinney
Texas Oncology-Northeast Texas
RECRUITING
Palestine
Texas Oncology-Northeast Texas
RECRUITING
Paris
Texas Oncology-Northeast Texas
RECRUITING
Tyler
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
Virginia Oncology Associates
NOT_YET_RECRUITING
Chesapeake
Virginia Cancer Specialists
NOT_YET_RECRUITING
Manassas
Bon Secours Cancer Institute at Memorial Regional Medical Center
RECRUITING
Mechanicsville
Virginia Cancer Specialists, PC
NOT_YET_RECRUITING
Reston
Virginia Oncology Associates
NOT_YET_RECRUITING
Virginia Beach
Virginia Oncology Associates
NOT_YET_RECRUITING
Williamsburg
Washington
Fred Hutchinson Cancer Center
NOT_YET_RECRUITING
Seattle
Other Locations
Australia
ICON Cancer Centre - Kurralta Park
NOT_YET_RECRUITING
Kurralta Park
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Western Health-Sunshine & Footscray Hospitals
RECRUITING
St Albans
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
Algemeen Ziekenhuis klina
RECRUITING
Brasschaat
Cliniques universitaires Saint-Luc
NOT_YET_RECRUITING
Brussels
AZ Groeninge Campus Kennedylaan
RECRUITING
Kortrijk
Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
RECRUITING
Ijuí
ANIMI - Unidade de Tratamento Oncologico
RECRUITING
Lages
Hospital São Lucas da PUCRS
NOT_YET_RECRUITING
Porto Alegre
IBCC - Núcleo de Pesquisa e Ensino
NOT_YET_RECRUITING
São Paulo
Afecc Associacao Feminina Educacao Combate Cancer
RECRUITING
Vitória
Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo
RECRUITING
Haskovo
Complex Oncology Center - Shumen
RECRUITING
Shumen
Multiprofile Hospital for Active Treatment Serdikamed EOOD
RECRUITING
Sofia
Canada
Centre Hospitalier de l'Université de Montréal
NOT_YET_RECRUITING
Montreal
CHU de Québec-Université Laval
RECRUITING
Québec
CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
RECRUITING
Québec
China
Affiliated Hospital of Hebei University
NOT_YET_RECRUITING
Baoding
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
The 2nd Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Southern Medical University Nanfang Hospital
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Anhui Provincial Cancer Hospital
RECRUITING
Hefei
Shandong Cancer Hospital
RECRUITING
Jinan
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
Finland
Docrates Syöpäsairaala
RECRUITING
Helsinki
Kuopion Yliopistollinen Sairaala
RECRUITING
Kuopio
Tampereen yliopistollinen sairaala
RECRUITING
Tampere
France
Institut Bergonié
NOT_YET_RECRUITING
Bordeaux
Centre François Baclesse
NOT_YET_RECRUITING
Caen
Hôpital de la Croix-Rousse
NOT_YET_RECRUITING
Lyon
Institut Régional du Cancer Montpellier
NOT_YET_RECRUITING
Montpellier
Centre Hospitalier Lyon Sud
NOT_YET_RECRUITING
Pierre-bénite
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer
NOT_YET_RECRUITING
Rennes
Institut de Cancérologie de Lorraine Alexis Vautrin
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
RECRUITING
Berlin
Universitaetsklinikum Erlangen
RECRUITING
Erlangen
Mammazentrum HH am Krankenhaus Jerusalem
NOT_YET_RECRUITING
Hamburg
Universitätsklinik Ulm
NOT_YET_RECRUITING
Ulm
Greece
IASO General Clinic
RECRUITING
Athens
University General Hospital of Heraklion
RECRUITING
Heraklion
Hygeia Hospital
RECRUITING
Marousi
Hungary
Semmelweis Egyetem
NOT_YET_RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont
NOT_YET_RECRUITING
Debrecen
India
Spandana Oncology Centre (SOC)
RECRUITING
Bengaluru
Apex Wellness Hospital
NOT_YET_RECRUITING
Nashik
Sahyadri Super Speciality Hospital
NOT_YET_RECRUITING
Pune
Nirmal Hospital Pvt Ltd.
RECRUITING
Surat
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
RECRUITING
Bologna
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
RECRUITING
Meldola
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Istituto Nazionale dei Tumori IRCCS Fondazione G Pascale
NOT_YET_RECRUITING
Naples
Japan
Juntendo University Hospital
RECRUITING
Bunkyo-ku
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
Tokai University Hospital
RECRUITING
Isehara
National Cancer Center Hospital East
RECRUITING
Kashiwa
Gunma Prefectural Cancer Center
RECRUITING
Otashi
Showa Medical University Hospital
RECRUITING
Tokyo
Kanagawa cancer center
RECRUITING
Yokohama
Mexico
COI Centro Oncologico Internacional S.A.P.I. de C.V.
RECRUITING
Mexico City
Centro de Investigacion Clinica de Oaxaca
RECRUITING
Oaxaca City
Netherlands
Franciscus Vlietland Ziekenhuis
RECRUITING
Schiedam
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
NOT_YET_RECRUITING
Bydgoszcz
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
NOT_YET_RECRUITING
Krakow
Republic of Korea
Gangnam Severance Hospital, Yonsei University Health System
RECRUITING
Gangnam-gu
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Slovakia
Narodny onkologicky ustav
RECRUITING
Bratislava
Onkologicky Ustav sv. Alzbety
RECRUITING
Bratislava
Vychodoslovensky Onkologicky ustav a.s.
RECRUITING
Košice
Spain
CHUAC-Complejo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Osi Bilbao-Basurto
RECRUITING
Bilbao
Hospital Universitario San Cecilio
RECRUITING
Granada
Hospital Universitario de Jaen
RECRUITING
Jaén
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Sweden
Sahlgrenska Universitetssjukhuset
RECRUITING
Gothenburg
Södersjukhuset
RECRUITING
Stockholm
Taiwan
Chi Mei Medical Center
RECRUITING
Tainan
Taipei Veterans General Hospital
RECRUITING
Taipei
Turkey
Ankara Bilkent Şehir Hastanesi
RECRUITING
Ankara
Memorial Ankara Hastanesi
RECRUITING
Ankara
Dicle Üniversitesi
RECRUITING
Diyarbakır
Medipol Mega Universite Hastanesi
RECRUITING
Istanbul
United Kingdom
Musgrove Park Hospital
NOT_YET_RECRUITING
Taunton
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
Other: 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

Similar Clinical Trials