Breast CancerPhase 3NCT07062965
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.
A Phase 3 study testing PF-07248144, Fulvestrant and Everolimus in people with Breast Cancer, run by Pfizer at 433 sites in 31 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PF-07248144, Fulvestrant and Everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 433 sitesin 31 countries
- Study dates
- 5 Aug 2025to 4 Nov 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Documented detectable PIK3CA/AKT1/PTEN alterations in tissue
- 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.
Trial locations and contacts
433 sites in 31 countries. Contact the study team or a site near you to ask about taking part.
433 sites in 31 countries
United States215 sites, 215 recruiting
- Recruiting
Providence Regional Cancer System - Aberdeen
Aberdeen, Washington, 98520
- Recruiting
Texas Oncology-West Texas
Abilene, Texas, 79606
- Recruiting
Texas Oncology-Northeast Texas
Allen, Texas, 75013
- Recruiting
Texas Oncology-West Texas
Amarillo, Texas, 79124
- Recruiting
Oncura Health - Anaheim
Anaheim, California, 92805
- Recruiting
Alaska Oncology and Hematology, LLC
Anchorage, Alaska, 99508
- Recruiting
Maryland Oncology Hematology P.A.
Annapolis, Maryland, 21401
- Recruiting
Virginia Cancer Specialists, PC
Arlington, Virginia, 22201
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
- Recruiting
Investigational Drug Service Emory University Clinic
Atlanta, Georgia, 30322
- Recruiting
Winship Cancer Institute
Atlanta, Georgia, 30322
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
- Recruiting
Rocky Mountain Cancer Centers LLP
Aurora, Colorado, 80012
- Recruiting
Texas Oncology - Central/South Texas
Austin, Texas, 78705
- Recruiting
Texas Oncology - Central South (Balcones Dr)
Austin, Texas, 78731
- Recruiting
Texas Oncology - Central South (James Casey)
Austin, Texas, 78745
- Recruiting
Texas Oncology - Central South (Renfert Way)
Austin, Texas, 78758
- Recruiting
Mercy Medical Center - Baltimore
Baltimore, Maryland, 21202
- Recruiting
Mfsmc-Hjwci
Baltimore, Maryland, 21237
- Recruiting
MedStar Franklin Square Cancer Center at Loch Raven
Baltimore, Maryland, 21239
- Recruiting
Maryland Oncology Hematology P.A.
Bethesda, Maryland, 20817
- Recruiting
The Cancer & Hematology Centers
Big Rapids, Michigan, 49307
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Rocky Mountain Cancer Centers LLP
Boulder, Colorado, 80303
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
- Recruiting
Maryland Oncology Hematology P.A.
Brandywine, Maryland, 20613
- Recruiting
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, 55337
- Recruiting
Ventura County Hematology Oncology Specialists
Camarillo, California, 93010
- Recruiting
Rocky Mountain Cancer Centers LLP
Centennial, Colorado, 80112
- Recruiting
Providence Regional Cancer System - Centralia
Centralia, Washington, 98531
- Recruiting
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
- Recruiting
Roper Hospital
Charleston, South Carolina, 29401
- Recruiting
Bon Secours St. Francis Hospital
Charleston, South Carolina, 29414
- Recruiting
Charleston Oncology, A Department of Bon Secours St. Francis Hospital
Charleston, South Carolina, 29414
- Recruiting
Roper St. Francis Healthcare, Clinical Biotechnology Research Institute (CBRI)
Charleston, South Carolina, 29414
- Recruiting
St. Francis Hospital Breast Care - Medical Plaza
Charleston, South Carolina, 29414
- Recruiting
Virginia Oncology Associates
Chesapeake, Virginia, 23320
- Recruiting
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, 63376
- Recruiting
Wake Forest Baptist Hematology and Oncology - Clemmons
Clemmons, North Carolina, 27012
- Recruiting
Rocky Mountain Cancer Centers LLP
Colorado Springs, Colorado, 80907
- Recruiting
Rocky Mountain Cancer Centers LLP
Colorado Springs, Colorado, 80923
- Recruiting
Maryland Oncology Hematology P.A.
Columbia, Maryland, 21044
- Recruiting
Missouri Cancer Associates
Columbia, Missouri, 65201
- Recruiting
MD Anderson The Woodlands
Conroe, Texas, 77384
- Recruiting
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, 55433
- Recruiting
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141
- Recruiting
Texas Oncology-Northeast Texas
Denison, Texas, 75020
- Recruiting
Texas Oncology-Northeast Texas
Denton, Texas, 76201
- Recruiting
Rocky Mountain Cancer Centers LLP
Denver, Colorado, 80220
- Recruiting
Smilow Cancer Hospital - Derby
Derby, Connecticut, 06418
- Recruiting
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, 48202
- Recruiting
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, 55435
- Recruiting
Texas Oncology-West Texas
El Paso, Texas, 79902
- Recruiting
Texas Oncology-West Texas
El Paso, Texas, 79915
- Recruiting
Texas Oncology-West Texas
El Paso, Texas, 79938
- Recruiting
Endeavor Health Cancer Institute at Swedish Hospital, Nancy W. Knowles Cancer Center
Elmhurst, Illinois, 60126
- Recruiting
Rocky Mountain Cancer Centers LLP
Englewood, Colorado, 80113
- Recruiting
Prime Saint Francis-Infusion Services Evanston
Evanston, Illinois, 60202
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Recruiting
Smilow Cancer Hospital - Fairfield
Fairfield, Connecticut, 06824
- Recruiting
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72703
- Recruiting
Siteman Cancer Center - North County
Florissant, Missouri, 63031
- Recruiting
Texas Oncology-Northeast Texas
Flower Mound, Texas, 75028
- Recruiting
Oncura Health - Fountain Valley
Fountain Valley, California, 92708
- Recruiting
Texas Oncology - San Antonio
Fredericksburg, Texas, 78624
- Recruiting
Maryland Oncology Hematology P.A.
Germantown, Maryland, 20876
- Recruiting
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38138
- Recruiting
Banner Gateway Medical Center
Gilbert, Arizona, 85234
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
- Recruiting
Ironwood Cancer & Research Centers
Gilbert, Arizona, 85297
- Recruiting
Smilow Cancer Hospital - Glastonbury
Glastonbury, Connecticut, 06033
- Recruiting
Ironwood Cancer & Research Centers
Glendale, Arizona, 85306
- Recruiting
Oncura Health - Corporate (Central IDS & Regulatory Only)
Glendale, California, 91204
- Recruiting
Ironwood Cancer & Research Centers
Goodyear, Arizona, 85395
- Recruiting
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49503
- Recruiting
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49546
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
- Recruiting
Smilow Cancer Hospital - Greenwich
Greenwich, Connecticut, 06830
- Recruiting
Smilow Cancer Hospital - Guilford
Guilford, Connecticut, 06437
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Recruiting
Texas Oncology - Central South (Pease)
Harlingen, Texas, 78550
- Recruiting
Smilow Cancer Hospital at Saint Francis
Hartford, Connecticut, 06105
- Recruiting
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052
- Recruiting
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074
- Recruiting
Hope and Healing Clinical Research LLC
Hinsdale, Illinois, 60521
- Recruiting
The Cancer & Hematology Centers
Holland, Michigan, 49424
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
MD Anderson West Houston
Houston, Texas, 77079
- Recruiting
US Oncology Investigation Products Center(IPC)
Irving, Texas, 75063
- Recruiting
US Oncology Investigational Product Center (IPC)
Irving, Texas, 75063
- Recruiting
US Oncology Investigational Products Center
Irving, Texas, 75063
- Recruiting
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
- Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
- Recruiting
Providence Regional Cancer System - Lacey
Lacey, Washington, 98503
- Recruiting
Rocky Mountain Cancer Centers LLP
Lakewood, Colorado, 80228
- Recruiting
Maryland Oncology Hematology P.A.
Largo, Maryland, 20774
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89106
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89144
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
- Recruiting
MD Anderson League City
League City, Texas, 77573
- Recruiting
Texas Oncology-Northeast Texas
Lewisville, Texas, 75056
- Recruiting
Rocky Mountain Cancer Centers LLP
Littleton, Colorado, 80120
- Recruiting
Rocky Mountain Cancer Centers LLP
Lone Tree, Colorado, 80124
- Recruiting
Rocky Mountain Cancer Centers LLP
Longmont, Colorado, 80504
- Recruiting
Texas Oncology-Northeast Texas
Longview, Texas, 75601
- Recruiting
Oncura Health - Good Samaritan
Los Angeles, California, 90017
- Recruiting
University Medical Center, Inc. ; DBA UofL Health - UofL Hospital/Brown Cancer Center
Louisville, Kentucky, 40202
- Recruiting
UofL Health Brown Cancer Center Medical Center Northeast
Louisville, Kentucky, 40245
- Recruiting
Virginia Cancer Specialists
Manassas, Virginia, 20110
- Recruiting
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, 55369
- Recruiting
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, 55109
- Recruiting
Texas Oncology - Central South (South 2nd)
McAllen, Texas, 78503
- Recruiting
Texas Oncology-Northeast Texas
McKinney, Texas, 75071
- Recruiting
Bon Secours Cancer Institute at Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
- Recruiting
Ironwood Cancer & Research Centers
Mesa, Arizona, 85202
- Recruiting
Ironwood Cancer & Research Centers
Mesa, Arizona, 85206
- Recruiting
Texas Oncology-West Texas
Midland, Texas, 79701
- Recruiting
Bon Secours St. Francis Medical Center
Midlothian, Virginia, 23114
- Recruiting
Aurora St Luke's Medical Center
Milwaukee, Wisconsin, 53215
- Recruiting
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404
- Recruiting
Roper St Francis Mount Pleasant Hospital
Mt. Pleasant, South Carolina, 29466
- Recruiting
Endeavor Health Cancer Institute at Swedish Hospital
Naperville, Illinois, 60540
- Recruiting
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37204
- Recruiting
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
- Recruiting
Texas Oncology - San Antonio
New Braunfels, Texas, 78130
- Recruiting
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, 06510
- Recruiting
Yale-New Haven Hospital
New Haven, Connecticut, 06510
- Recruiting
Hope and Healing Clinical Research
New Lenox, Illinois, 60451
- Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, 70112
- Recruiting
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02467
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
- Recruiting
Charleston Oncology - A Department of Bon Secours St. Francis Hospital
North Charleston, South Carolina, 29406
- Recruiting
Smilow Cancer Hospital - North Haven
North Haven, Connecticut, 06473
- Recruiting
The Cancer & Hematology Centers
Norton Shores, Michigan, 49444
- Recruiting
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
- Recruiting
Texas Oncology-West Texas
Odessa, Texas, 79761
- Recruiting
Dr. Karandeep Singh MD
Oxnard, California, 93030
- Recruiting
Rolling Oaks Radiology - Oxnard
Oxnard, California, 93030
- Recruiting
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030
- Recruiting
Rolling Oaks Radiology North Solar
Oxnard, California, 93036
- Recruiting
Texas Oncology-Northeast Texas
Palestine, Texas, 75801
- Recruiting
Clinical and Translational Research Unit (CTRU)
Palo Alto, California, 94304
- Recruiting
Stanford Cancer Center
Palo Alto, California, 94304
- Recruiting
Stanford Women's Cancer Center
Palo Alto, California, 94304
- Recruiting
Texas Oncology-Northeast Texas
Paris, Texas, 75460
- Recruiting
Advocate Medical Group-Park Ridge, Luther Lane-Oncology
Park Ridge, Illinois, 60068
- Recruiting
Ironwood Cancer & Research Centers
Phoenix, Arizona, 85028
- Recruiting
Minnesota Oncology Hematology, P.A.
Plymouth, Minnesota, 55441
- Recruiting
Rocky Mountain Cancer Centers LLP
Pueblo, Colorado, 81003
- Recruiting
Renown Health Medical Oncology
Reno, Nevada, 89502
- Recruiting
Renown Office of Clinical Research
Reno, Nevada, 89502
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
- Recruiting
Renown Health Conrad Breast Center
Reno, Nevada, 89521
- Recruiting
Renown Office of Clinical Research South Meadows
Reno, Nevada, 89521
- Recruiting
Virginia Cancer Specialists, PC
Reston, Virginia, 20190
- Recruiting
Bon Secours Cancer Institute at St. Mary's Hospital
Richmond, Virginia, 23226
- Recruiting
University of Rochester Cancer Center Pharmacy
Rochester, New York, 14642
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
- Recruiting
Maryland Oncology Hematology P.A.
Rockville, Maryland, 20850
- Recruiting
Highlands Oncology Group, PA
Rogers, Arkansas, 72758
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
- Recruiting
Texas Oncology - San Antonio
San Antonio, Texas, 78217
- Recruiting
Texas Oncology - San Antonio
San Antonio, Texas, 78240
- Recruiting
Texas Oncology - San Antonio
San Antonio, Texas, 78258
- Recruiting
Sansum Clinic
Santa Barbara, California, 93105
- Recruiting
Summit Cancer Care, PC
Savannah, Georgia, 31405
- Recruiting
Summit Cancer Care
Savannah, Georgia, 31405
- Recruiting
Ironwood Cancer & Research Centers
Scottsdale, Arizona, 85260
- Recruiting
Harborview Medical Center
Seattle, Washington, 98104
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
- Recruiting
Memorial Hospital.
Shiloh, Illinois, 62269
- Recruiting
Siteman Cancer Center - Shiloh
Shiloh, Illinois, 62269
- Recruiting
Maryland Oncology Hematology P.A.
Silver Spring, Maryland, 20904
- Recruiting
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077
- Recruiting
Prime Saint Francis-Infusion Services Skokie
Skokie, Illinois, 60077
- Recruiting
Sansum Clinic
Solvang, California, 93463
- Recruiting
Highlands Oncology Group, PA
Springdale, Arkansas, 72762
- Recruiting
Siteman Cancer Center
St Louis, Missouri, 63108
- Recruiting
Barnes-Jewish Hospital
St Louis, Missouri, 63110
- Recruiting
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
- Recruiting
Siteman Cancer Center - South County
St Louis, Missouri, 63129
- Recruiting
David C. Pratt Cancer Center
St Louis, Missouri, 63141
- Recruiting
Smilow Cancer Hospital - Long Ridge
Stamford, Connecticut, 06902
- Recruiting
MD Anderson in Sugar Land
Sugar Land, Texas, 77478
- Recruiting
Roper St. Francis Hospital - Berkeley
Summerville, South Carolina, 29486
- Recruiting
Rocky Mountain Cancer Centers LLP
Thornton, Colorado, 80260
- Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
- Recruiting
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505
- Recruiting
Torrance Memorial Physician Network-Cancer Care
Torrance, California, 90505
- Recruiting
Harbor-UCLA Medical Center
Torrance, California, 90509
- Recruiting
Smilow Cancer Hospital - Torrington
Torrington, Connecticut, 06790
- Recruiting
Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut, 06611
- Recruiting
Texas Oncology-Northeast Texas
Tyler, Texas, 75702
- Recruiting
Oncura Health - Valley Presbyterian
Van Nuys, California, 91405
- Recruiting
Ventura County Hematology Oncology Specialists
Ventura, California, 93003
- Recruiting
Virginia Oncology Associates
Virginia Beach, Virginia, 23456
- Recruiting
Texas Oncology - Central South (Horizon Cir)
Waco, Texas, 76712
- Recruiting
Texas Oncology - Central South
Waco, Texas, 76712
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
- Recruiting
Smilow Cancer Hospital - Waterbury
Waterbury, Connecticut, 06708
- Recruiting
Smilow Cancer Hospital - Waterford
Waterford, Connecticut, 06385
- Recruiting
Texas Oncology - Central South (E 6th St)
Weslaco, Texas, 78596
- Recruiting
Texas Oncology-West Texas
Wichita Falls, Texas, 76310
- Recruiting
Virginia Oncology Associates
Williamsburg, Virginia, 23188
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
- Recruiting
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, 55125
China24 sites, 24 recruiting
- Recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei, 071066
- Recruiting
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
- Recruiting
The 2nd Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116023
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
- Recruiting
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515
- Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
- Recruiting
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou, Zhejiang, 310017
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
- Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
- Recruiting
Nanchang People's Hospital
Nanchang, Jiangxi, 330025
- Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
- Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210031
- Recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530020
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
- Recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
Japan16 sites, 16 recruiting
- Recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
- Recruiting
Chiba cancer center
Chiba, Chiba, 260-8717
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
- Recruiting
St. Luke's International Hospital
Chuo-ku, Tokyo, 104-8560
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
- Recruiting
Hiroshima City Hospital
Hiroshima, 730-8518
- Recruiting
Tokai University Hospital
Isehara, Kanagawa, 259-1193
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
- Recruiting
The Cancer Institute Hospital of JFCR
Koto, Tokyo, 135-8550
- Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
- Recruiting
Okayama University Hospital
Okayama, 700-8558
- Recruiting
Gunma Prefectural Cancer Center
Otashi, Gunma, 373-8550
- Recruiting
Japan Institute for Health Security National Center for Global Health and Medicine
Shinjuku-ku, Tokyo, 162-8655
- Recruiting
The University of Osaka Hospital
Suita, Osaka, 565-0871
- Recruiting
Showa Medical University Hospital
Tokyo, 142-8666
- Recruiting
Kanagawa cancer center
Yokohama, Kanagawa, 2418515
France13 sites, 13 recruiting
- Recruiting
CHU Besançon
Besançon, 25000
- Recruiting
Institut Bergonié
Bordeaux, 33076
- Recruiting
CHU de Brest - Hôpital de la Cavale Blanch
Brest, Finistère, 29200
- Recruiting
Hôpital Femme Mère Enfant
Bron, Rhône, 69500
- Recruiting
Centre François Baclesse
Caen, 14076
- Recruiting
Hôpital de la Croix-Rousse
Lyon, Rhône, 69004
- Recruiting
Institut Paoli-Calmettes
Marseille, 13009
- Recruiting
Institut Régional du Cancer Montpellier
Montpellier, Hérault, 34298
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, 69310
- Recruiting
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer
Rennes, Brittany Region, 35042
- Recruiting
Institut Curie - site Saint-Cloud
Saint-Cloud, Hauts-de-seine, 92210
- Recruiting
Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, Lorraine, 54519
- Recruiting
Institut Gustave Roussy
Villejuif, 94800
South Korea11 sites, 11 recruiting
- Recruiting
Kyungpook National University Chilgok Hospital
Deagu, Taegu-kwangyǒkshi, 41404
- Recruiting
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, Seoul-teukbyeolsi [seoul], 06273
- Recruiting
National Cancer Center
Goyang-si, Kyǒnggi-do, 10408
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Kyǒnggi-do, 13620
- Recruiting
Korea University Anam Hospital
Seoul, Seoul-teukbyeolsi [seoul], 02841
- Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722
- Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 05505
- Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351
- Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], 06591
- Recruiting
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [seoul], 08308
Germany10 sites, 10 recruiting
- Recruiting
Hämatologie-onkologie im Zentrum MVZ GmbH
Augsburg, Bavaria, 86150
- Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, 10117
- Recruiting
Praxisklinik Krebsheilkunde fur Frauen
Berlin, 10367
- Recruiting
Praxisklinik Krebsheilkunde fur Frauen
Berlin, 13597
- Recruiting
Universitaetsklinikum Erlangen
Erlangen, Bavaria, 91054
- Recruiting
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, North Rhine-Westphalia, 45136
- Recruiting
Mammazentrum HH am Krankenhaus Jerusalem
Hamburg, 20357
- Recruiting
Otto-von-Guericke-Universität, Medizinische Fakultät Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, Saxony-Anhalt, 39108
- Recruiting
MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum
Ravensburg, Baden-Wurttemberg, 88212
- Recruiting
Universitätsklinik Ulm
Ulm, Baden-Wurttemberg, 89075
India10 sites, 10 recruiting
- Recruiting
Spandana Oncology Centre (SOC)
Bengaluru, Karnataka, 560069
- Recruiting
Institute of Medical Sciences and Sum Hospital
Bhubaneswar, Odisha, 751003
- Recruiting
Artemis hospital
Gurugram, Haryana, 122001
- Recruiting
Sawai Man Singh Medical College Hospital (SMS Hospital)
Jaipur, Rajasthan, 302004
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
- Recruiting
HCG Manavata Cancer Centre
Nashik, Maharashtra, 422002
- Recruiting
Apex Wellness Hospital
Nashik, Maharashtra, 422009
- Recruiting
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004
- Recruiting
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, 395002
- Recruiting
Bhakti Vedanta Hospital and Research Institute
Thane, Maharashtra, 401107
Belgium9 sites, 9 recruiting
- Recruiting
Institut Jules Bordet
Anderlecht, Bruxelles-capitale, Région de, 1070
- Recruiting
Algemeen Ziekenhuis klina
Brasschaat, Antwerpen, 2930
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-capitale, Région de, 1200
- Recruiting
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6060
- Recruiting
Jessa Ziekenhuis
Hasselt, Limburg, 3500
- Recruiting
AZ Groeninge Campus Kennedylaan
Kortrijk, West-vlaanderen, 8500
- Recruiting
UZ Leuven
Leuven, Vlaams-brabant, 3000
- Recruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000
- Recruiting
Clinique Saint Pierre
Ottignies-Louvain-la-Neuve, Brabant Wallon, 1340
Brazil9 sites, 9 recruiting
- Recruiting
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, Rio Grande do Sul, 98700-000
- Recruiting
ANIMI - Unidade de Tratamento Oncologico
Lages, Santa Catarina, 88501001
- Recruiting
Hospital de Cancer de Londrina
Londrina, Paraná, 86015-520
- Recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560032
- Recruiting
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
- Recruiting
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, São Paulo, 09541-270
- Recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
- Recruiting
IBCC - Núcleo de Pesquisa e Ensino
São Paulo, 04014-002
- Recruiting
Afecc Associacao Feminina Educacao Combate Cancer
Vitória, Espírito Santo, 29043-260
Italy9 sites, 9 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, 40138
- Recruiting
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno
Livorno, Tuscany, 57124
- Recruiting
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, 47014
- Recruiting
Ospedale San Raffaele
Milan, 20132
- Recruiting
Istituto Europeo di Oncologia IRCCS
Milan, 20141
- Recruiting
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, 41124
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, 20900
- Recruiting
Istituto Nazionale dei Tumori IRCCS Fondazione G Pascale
Naples, Naples, 80131
- Recruiting
Istituto Nazionale Tumori Regina Elena
Rome, ROMA, 00144
Spain9 sites, 9 recruiting
- Recruiting
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña], 15006
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], 08036
- Recruiting
Osi Bilbao-Basurto
Bilbao, Basque Country, 48013
- Recruiting
Hospital Universitario San Cecilio
Granada, 18016
- Recruiting
Hospital Universitario de Jaen
Jaén, 23007
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29010
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Canada8 sites, 8 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
- Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
- Recruiting
CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
Québec, Quebec, G1S 4L8
- Recruiting
CHU de Québec-Université Laval
Québec, G1R 2J6
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Bulgaria7 sites, 7 recruiting
- Recruiting
Complex Oncology Center - Burgas
Burgas, 8000
- Recruiting
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, 6300
- Recruiting
Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4004
- Recruiting
Complex Oncology Center - Shumen
Shumen, 9700
- Recruiting
Multiprofile Hospital for Active Treatment Serdikamed EOOD
Sofia, Sofia (stolitsa), 1632
- Recruiting
MHAT for Women's Health Nadezhda
Sofia, 1330
- Recruiting
"University Specialized Hospital for Active Treatment of Oncology Prof. Ivan Chernozemski" EAD
Sofia, 1756
Greece7 sites, 7 recruiting
- Recruiting
University General Hospital of Alexandroupoli
Alexandroupoli, East Macedonia and Thrace, 68100
- Recruiting
IASO General Clinic
Athens, Attica, 151 23
- Recruiting
Aretaieio Hospital
Athens, 11528
- Recruiting
University General Hospital of Heraklion
Heraklion, Irakleío, 71500
- Recruiting
University General Hospital of Larissa
Larissa, Thessalía, 411 10
- Recruiting
Hygeia Hospital
Marousi, Attikí, 151 23
- Recruiting
European Interbalkan Medical Center
Thessaloniki, Thessaloníki, 570 01
Slovakia7 sites, 7 recruiting
- Recruiting
Onkologicky Ustav sv. Alzbety
Bratislava, Bratislava Region, 812 50
- Recruiting
Narodny onkologicky ustav
Bratislava, 833 10
- Recruiting
Nemocnica AGEL Komarno
Komárno, Nitra Region, 945 05
- Recruiting
Vychodoslovensky Onkologicky ustav a.s.
Košice, Košice Region, 041 91
- Recruiting
Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s.
Michalovce, Košice Region, 071 01
- Recruiting
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, 940 34
- Recruiting
Fakultna nemocnica Trnava
Trnava, 917 75
Taiwan7 sites, 7 recruiting
- Recruiting
Chi Mei Medical Center
Tainan, Tainan, 71004
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
- Recruiting
National Taiwan University Hospital
Taipei, 10002
- Recruiting
Mackay Memorial Hospital
Taipei, 104217
- Recruiting
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112019
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
- Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Hacettepe Universite Hastaneleri
Ankara, 06230
- Recruiting
Memorial Ankara Hastanesi
Ankara, 06520
- Recruiting
Ankara Bilkent Şehir Hastanesi
Ankara, 06800
- Recruiting
Dicle Üniversitesi
Diyarbakır, 21200
- Recruiting
Medipol Mega Universite Hastanesi
Istanbul, İ̇stanbul, 34214
- Recruiting
İ.A.Ü VM Medical Park Florya Hastanesi
Küçükçekmece, İ̇stanbul, 34295
- Recruiting
Samsun Medical Park Hastanesi
Samsun, 55200
Czechia6 sites, 6 recruiting
- Recruiting
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín, 741 01
- Recruiting
Fakultni Thomayerova nemocnice
Prague, Praha 4, 14059
- Recruiting
Fakultni nemocnice Bulovka
Prague, Praha 8, 180 81
- Recruiting
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34
- Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 128 08
- Recruiting
Fakultni nemocnice Motol a Homolka
Prague, 150 00
Israel6 sites, 6 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, Northern District, 3109601
- Recruiting
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9013102
- Recruiting
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001
- Recruiting
Rabin Medical Center
Petah Tikva, Central District, 4941492
- Recruiting
Sheba Medical Center
Ramat Gan, Central District, 5265601
- Recruiting
Sourasky Medical Center
Tel Aviv, TELL ABĪB, 6423906
United Kingdom6 sites, 6 recruiting
- Recruiting
University Hospital Coventry & Warwickshire
Coventry, Warwickshire, CV2 2DX
- Recruiting
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
- Recruiting
Maidstone & Tunbridge Wells NHS Trust
Maidstone, KENT, ME16 9QQ
- Recruiting
Peterborough City Hospital
Peterborough, PE3 9GZ
- Recruiting
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
- Recruiting
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA
Argentina5 sites, 5 recruiting
- Recruiting
IADT - Instituto Argentino de diagnóstico y Tratamiento
Buenos Aires, Buenos Aires F.D., C1122AAL
- Recruiting
Centro Medico Fleischer
Buenos Aires, 1414
- Recruiting
Organizacion Medica de Investigacion
CABA, Buenos Aires F.D., C1015ABO
- Recruiting
Fundación Respirar
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP
- Recruiting
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja, F5300COE
Australia5 sites, 5 recruiting
- Recruiting
Cancer Research SA Pty Ltd
Adelaide, South Australia, 5000
- Recruiting
ICON Cancer Centre - Kurralta Park
Kurralta Park, South Australia, 5037
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
- Recruiting
Western Health-Sunshine & Footscray Hospitals
St Albans, Victoria, 3021
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Mexico5 sites, 5 recruiting
- Recruiting
Sitio Clínico UIS Chihuahua
Chihuahua City, 31203
- Recruiting
COI Centro Oncologico Internacional S.A.P.I. de C.V.
Mexico City, 04700
- Recruiting
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, 68020
- Recruiting
Fundación Santos y de la Garza Evia I.B.P
San Pedro Garza García, 66278
- Recruiting
COI/ CENTRO ONCOLOGICO INTERNACIONAL SAPI de CV
Tlajomulco de Zuñiga, Jalisco, 45640
Poland5 sites, 5 recruiting
- Recruiting
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
- Recruiting
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, Lesser Poland Voivodeship, 30-348
- Recruiting
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, 45-061
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, 02-781
- Recruiting
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
Wroclaw, Lower Silesian Voivodeship, 53-413
Finland4 sites, 4 recruiting
- Recruiting
Docrates Syöpäsairaala
Helsinki, Uusimaa, 00180
- Recruiting
Kuopion Yliopistollinen Sairaala
Kuopio, Northern Savonia, 70210
- Recruiting
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, 33520
- Recruiting
Vaasan Keskussairaala
Vaasa, Pohjanmaa, 65130
Hungary3 sites, 3 recruiting
- Recruiting
Semmelweis Egyetem
Budapest, 1082
- Recruiting
Országos Onkológiai Intézet Mellkasi es Hasuregi Daganatok es Klinikai Farmakologiai Osztaly
Budapest, 1122
- Recruiting
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
New Zealand3 sites, 3 recruiting
- Recruiting
Auckland City Hospital
Auckland, 1023
- Recruiting
Christchurch Hospital
Christchurch, Canterbury, 8011
- Recruiting
Capital, Coast and Hutt Valley District - Wellington Regional Hospital
Wellington, 6021
Netherlands2 sites, 2 recruiting
- Recruiting
Tergooi MC
Hilversum, North Holland, 1212 VG
- Recruiting
Franciscus Vlietland Ziekenhuis
Schiedam, South Holland, 3118 JH
South Africa2 sites, 2 recruiting
- Recruiting
The Oncology Centre
Durban, KwaZulu-Natal, 4091
- Recruiting
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset
Gothenburg, SE-41345
- Recruiting
Södersjukhuset
Stockholm, Stockholms LÄN [se-01], 11883
Puerto Rico1 site, 1 recruiting
- Recruiting
Ad-Vance Medical Research
Ponce, 00717
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- PF-07248144, Fulvestrant, Everolimus, Exemestane
- Keywords
- Locally advanced or metastatic breast cancer, Estrogen receptor positive [ER(+)], Progesterone receptor positive [PR(+)], Human epidermal growth factor receptor 2 negative [HER2(-)], ER(+)/HER2(-), PR(+)/HER2(-), HR(+)/HER2(-), Advanced Breast Cancer, Breast tumor, Breast cancer, Everolimus, Exemestane, Fulvestrant, Metastatic breast cancer, Endocrine Therapy, Hormone Therapy, Hormone positive breast cancer, Recurrent breast cancer, HR+, HER2-negative
- Medical subject headings
- Breast Neoplasms, Recurrence, Unilateral Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07248144Drug
KAT6 inhibitor
FulvestrantDrug
Endocrine therapy
EverolimusDrug
mTOR inhibitor
ExemestaneDrug
Endocrine therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A: PF-07248144 plus fulvestrant | Other | PF-07248144 tablet taken by mouth plus fulvestrant taken as a shot into the muscle. Receives: Drug: PF-07248144; Drug: Fulvestrant |
| Arm B: everolimus plus ET | Active comparator | 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. Receives: Drug: Fulvestrant; Drug: Everolimus; Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: From the date of randomization until disease progression or death due to any cause (up to approximately 2 years)
Secondary outcomes (12)
Overall Survival (OS)
Measured: From the date of randomization until death due to any cause (up to approximately 5 years).
Number of Participants with Objective Response (OR) by BICR
Measured: From the date of randomization until disease progression or death due to any cause (up to approximately 2 years)
Duration of Response (DoR) as defined by BICR
Measured: From the date of the first objective (PR or CR) response (every 8 weeks during the first 48 weeks and then every 12 week) up to approximately 2 years.
Number of Participants With Clinical Benefit Response (CBR) by BICR
Measured: From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years.
Number or Patients with Adverse Events (AEs) by Type
Measured: From screening until 28 days after the last dose, to approximately 5 years
Number or Patients with AEs by Incidence
Measured: From screening until 28 days after the last dose, to approximately 5 years
Number or Patients with AEs by Seriousness
Measured: From screening until 28 days after the last dose, to approximately 5 years
Number or Patients with AEs by relationship to study interventions
Measured: From screening until 28 days after the last dose, to approximately 5 years
Number of Participants With Abnormal Electrocardiogram (ECG; Arm A and B)
Measured: From screening until 28 days after the last dose, to approximately 5 years
Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval (Arm A only)
The study includes a QTc sub-study in approximately 40 participants in Arm A enrolled at selected sites which will evaluate the effect of PF-07248144 on QTc interval via collection of triplicate ECGs (central reading) time-matched with pharmacokinetic (PK) draws.
Measured: 0h pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, and Cycle 3 Day 1; additional 4 hrs post dose on Cycle 1 Day 15 and Cycle 2 Day 1
Number of Participants With Laboratory Test Abnormalities
Measured: From screening until 28 days after the last dose, to approximately 5 years
Ctrough of PF-07248144
Ctrough was defined as pre-dose serum concentration during multiple dosing and observed directly from data.
Measured: Cycle 1 (Day 1), Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycles 3, 5, and 7 (Day 1) only. Each Cycle is 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start5 Aug 2025
- Primary completion22 Jul 2027 (estimated)
- Study completion4 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be randomly assigned into 1 of 2 groups in parallel for the entire duration of the study. The experimental arm will receive PF-07248144 and fulvestrant (Arm A) while the comparator arm will receive everolimus in combination with the study doctor's choice of endocrine therapy (exemestane or fulvestrant; Arm B).
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062965
- Sponsor's protocol ID
- C4551002
- Other IDs
- 2025-520566-22-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07062965
- Acronym / sponsor ID
- C4551002
- Conditions
- Breast Cancer
- Keywords
- Locally advanced or metastatic breast cancer, Estrogen receptor positive [ER(+)], Progesterone receptor positive [PR(+)], Human epidermal growth factor receptor 2 negative [HER2(-)], ER(+)/HER2(-), PR(+)/HER2(-), HR(+)/HER2(-), Advanced Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 22 Jul 2027 (estimated)
- Study completion
- 4 Nov 2030 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study participants will be randomly assigned into 1 of 2 groups in parallel for the entire duration of the study. The experimental arm will receive PF-07248144 and fulvestrant (Arm A) while the comparator arm will receive everolimus in combination with the study doctor's choice of endocrine therapy (exemestane or fulvestrant; Arm B).
| Arm | Type | Receives |
|---|---|---|
| Arm A: PF-07248144 plus fulvestrant | Other | Drug: PF-07248144, Drug: FulvestrantPF-07248144 tablet taken by mouth plus fulvestrant taken as a shot into the muscle. |
| Arm B: everolimus plus ET | Active comparator | Drug: Fulvestrant, Drug: Everolimus, Drug: ExemestaneEverolimus 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Documented detectable PIK3CA/AKT1/PTEN alterations in tissue
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07248144KAT6 inhibitor | Drug | Arm A: PF-07248144 plus fulvestrant |
| FulvestrantEndocrine therapy | Drug | Arm A: PF-07248144 plus fulvestrant, Arm B: everolimus plus ET |
| EverolimusmTOR inhibitor | Drug | Arm B: everolimus plus ET |
| ExemestaneEndocrine therapy | Drug | Arm B: everolimus plus ET |
Primary outcome
Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: From the date of randomization until disease progression or death due to any cause (up to approximately 2 years)
12 secondary outcomes
Overall Survival (OS)
Time frame: From the date of randomization until death due to any cause (up to approximately 5 years).
Number of Participants with Objective Response (OR) by BICR
Time frame: From the date of randomization until disease progression or death due to any cause (up to approximately 2 years)
Duration of Response (DoR) as defined by BICR
Time frame: From the date of the first objective (PR or CR) response (every 8 weeks during the first 48 weeks and then every 12 week) up to approximately 2 years.
Number of Participants With Clinical Benefit Response (CBR) by BICR
Time frame: From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years.
Number or Patients with Adverse Events (AEs) by Type
Time frame: From screening until 28 days after the last dose, to approximately 5 years
Number or Patients with AEs by Incidence
Time frame: From screening until 28 days after the last dose, to approximately 5 years
Number or Patients with AEs by Seriousness
Time frame: From screening until 28 days after the last dose, to approximately 5 years
Number or Patients with AEs by relationship to study interventions
Time frame: From screening until 28 days after the last dose, to approximately 5 years
Number of Participants With Abnormal Electrocardiogram (ECG; Arm A and B)
Time frame: From screening until 28 days after the last dose, to approximately 5 years
Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval (Arm A only)
Time frame: 0h pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, and Cycle 3 Day 1; additional 4 hrs post dose on Cycle 1 Day 15 and Cycle 2 Day 1
Number of Participants With Laboratory Test Abnormalities
Time frame: From screening until 28 days after the last dose, to approximately 5 years
Ctrough of PF-07248144
Time frame: Cycle 1 (Day 1), Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycles 3, 5, and 7 (Day 1) only. Each Cycle is 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- To obtain contact information for the Katsis-1 study, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
433 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PF-07248144, Fulvestrant and Everolimus in people with Breast Cancer, run by Pfizer at 433 sites in 31 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 433 sites in United States, China, Japan, France, South Korea and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: From the date of randomization until disease progression or death due to any cause (up to approximately 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.