Studie av Sacituzumab Govitecan-hziy og Pembrolizumab versus behandling av legens valg hos pasienter med trippel negativ brystkreft som har gjenværende invasiv sykdom etter kirurgi og neoadjuvant terapi
3. november 2026 oppdatert av: Gilead Sciences
En randomisert, åpen fase 3-studie av adjuvant Sacituzumab Govitecan og Pembrolizumab versus behandling av legens valg hos pasienter med trippel negativ brystkreft som har gjenværende invasiv sykdom etter kirurgi og neoadjuvant terapi
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
1514
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Gilead Clinical Study Information Center
- Telefonnummer: 1-833-445-3230 (GILEAD-0)
- E-post: GileadClinicalTrials@gilead.com
Studiesteder
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New South Wales
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Campbelltown, New South Wales, Australia, 2560
- Rekruttering
- Macarthur Cancer Therapy Centre, Campbelltown Hospital
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Darlinghurst, New South Wales, Australia, 2010
- Tilbaketrukket
- Kinghorn Cancer Centre
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Gateshead, New South Wales, Australia, 2290
- Rekruttering
- Lake Macquarie Private Hospital
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Port Macquarie, New South Wales, Australia, 2444
- Rekruttering
- Port Macquarie Base Hospital
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Queensland
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Cairns, Queensland, Australia, 4870
- Rekruttering
- Cairns Hospital
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Douglass, Queensland, Australia, 4818
- Rekruttering
- Townsville University Hospital
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Woolloongabba, Queensland, Australia, 4102
- Rekruttering
- Princess Alexandra Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Rekruttering
- Cancer Research SA
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Victoria
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Bendigo, Victoria, Australia, 3551
- Rekruttering
- Bendigo Health
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Clayton, Victoria, Australia, 3168
- Rekruttering
- Monash Medical Centre
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Rekruttering
- Fiona Stanley Hospital
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-
-
-
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Anderlecht, Belgia, 1070
- Rekruttering
- Institut Jules Bordet
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Brasschaat, Belgia, 2930
- Aktiv, ikke rekrutterende
- AZ Klina
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Brussels, Belgia, 1160
- Rekruttering
- Chirec Delta Hospital
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Gilly, Belgia, 6060
- Aktiv, ikke rekrutterende
- Grand Hopital de Charleroi asbl (GHdC)
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Hasselt, Belgia, 3500
- Rekruttering
- Jessa Ziekenhuis
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Leuven, Belgia, 3000
- Rekruttering
- UZ Leuven
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Liège, Belgia, 4000
- Rekruttering
- Clinique CHC MontLégia
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Roeselare, Belgia, 8800
- Rekruttering
- AZ Delta vzw
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Sint-Niklaas, Belgia, 9100
- Aktiv, ikke rekrutterende
- AZ Vitaz
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Wilrijk, Belgia, 2610
- Rekruttering
- Ziekenhuls aan de Stroom vzw (ZAS vzw), ZAS Augustinus
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-
-
-
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Brasília, Brasil, 71681-603
- Rekruttering
- St. de Habitações Individuais Sul QI 15 - Lago Sul, Brasília - DF, Brasil
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Curitiba, Brasil, 80510-130
- Rekruttering
- Rua Myltho Anselmo da Silva, 870 - Mercês, Curitiba - PR, CEP 80510-130
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Curitiba, Brasil, 80040-170
- Rekruttering
- Rua Padre Germano Mayer, 1949, Hugo Lange, Curitiba, Paraná
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Ijuí, Brasil, 98700-000
- Rekruttering
- Oncosite
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Itajaí, Brasil, 88300-000
- Rekruttering
- R. Aderbal Ramos da Silva, 148 - Centro, Itajaí - SC, 88300-000, Brasil
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Natal, Brasil, 59062-200
- Rekruttering
- Av. Miguel Castro, 1355, Nossa Senhora de Nazaré, Natal/RN
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Porto Alegre, Brasil, 90020-090
- Rekruttering
- Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, , Brasil
-
Porto Alegre, Brasil, 90470-340
- Rekruttering
- Av. Soledad, 569, sala 1103, Três Figueiras, CEP 90470-340
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Porto Alegre, Brasil, 90610-000
- Rekruttering
- Av. Ipiranga 6690
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Recife, Brasil, 50070-480
- Aktiv, ikke rekrutterende
- Hospital Esperança SA
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Recife, Brasil, 52011-906
- Rekruttering
- Instituto Santa Joana Recife de Ensino e Pesquisa
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Rio de Janiero, Brasil, 20560-121
- Rekruttering
- Instituto D'Or de Pesquisa e Ensino - RJ
-
Salvador, Brasil, 40170-110
- Rekruttering
- Av. Milton Santos, 123 - Ondina, Salvador - BA, , Brasil
-
Salvador, Brasil, 41950-640
- Aktiv, ikke rekrutterende
- AMO Clinic - Rio Vermelho
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São Paulo, Brasil, 01317-000
- Rekruttering
- Av. Brigadeiro Luís Antônio 733, loja 8
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São Paulo, Brasil, 01323-001
- Rekruttering
- Martiiano de Carvalho 965
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São Paulo, Brasil, 01509-010
- Rekruttering
- CIPE Centro Internacional de Pesquisa; A.C. Camargo Cancer Center
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São Paulo, Brasil, 01308-060
- Aktiv, ikke rekrutterende
- Hospital Sirio Libanês - SP
-
São Paulo, Brasil, 04501-000
- Aktiv, ikke rekrutterende
- Instituto D'Or de Pesquisa e Ensino SP
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Teresina, Brasil, 60449-200
- Rekruttering
- Rua Gardênia, 710, Edifício Prime, 4º andar, Bairro Jóquei, Teresina - PI, CEP 60449-200
-
-
-
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Alabama
-
Birmingham, Alabama, Forente stater, 35243
- Rekruttering
- Alabama Oncology
-
Huntsville, Alabama, Forente stater, 35805
- Rekruttering
- Clearview Cancer Institute
-
-
Arizona
-
Glendale, Arizona, Forente stater, 85304
- Rekruttering
- Palo Verde Hematology Oncology
-
Phoenix, Arizona, Forente stater, 85054
- Tilbaketrukket
- Mayo Clinic Hospital
-
Prescott Valley, Arizona, Forente stater, 86314
- Tilbaketrukket
- Arizona Oncology Associates
-
-
California
-
Berkeley, California, Forente stater, 94704
- Rekruttering
- Alta Bates Summit Medical Center
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Clovis, California, Forente stater, 93611
- Tilbaketrukket
- Community Cancer Institute
-
Downey, California, Forente stater, 90241
- Rekruttering
- PIH Health Whittier Hospital
-
Fountain Valley, California, Forente stater, 92708
- Aktiv, ikke rekrutterende
- Compassionate Cancer Care Medical Group - Inc
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Los Angeles, California, Forente stater, 90033
- Tilbaketrukket
- USC Norris Comprehensive Cancer Center
-
Los Angeles, California, Forente stater, 90048
- Rekruttering
- Cedars-Sinai Cancer at Beverly Hills
-
Los Angeles, California, Forente stater, 90017
- Aktiv, ikke rekrutterende
- Los Angeles Cancer Network
-
Newport Beach, California, Forente stater, 92663
- Rekruttering
- Hoag Memorial Hospital Presbyterian
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Redlands, California, Forente stater, 92373
- Tilbaketrukket
- Emad Ibrahim, MD, INC
-
Sacramento, California, Forente stater, 95816
- Rekruttering
- Sutter Institute for Medical Research
-
San Francisco, California, Forente stater, 94143
- Rekruttering
- UCSF Medical Center
-
San Francisco, California, Forente stater, 94143
- Rekruttering
- City of Hope (Duarte)
-
Santa Barbara, California, Forente stater, 93105
- Rekruttering
- Sansum Clinic
-
Stockton, California, Forente stater, 95204
- Rekruttering
- Stockton Hematology Oncology Medical Group
-
-
Colorado
-
Aurora, Colorado, Forente stater, 80045
- Tilbaketrukket
- University of Colorado Cancer Center
-
-
Connecticut
-
Danbury, Connecticut, Forente stater, 06810
- Tilbaketrukket
- Norwalk Hospital
-
Stamford, Connecticut, Forente stater, 06902
- Rekruttering
- Stamford Hospital
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forente stater, 20007
- Rekruttering
- MedStar Georgetown University Hospital
-
Washington D.C., District of Columbia, Forente stater, 20010
- Rekruttering
- MedStar Washington Hospital Center
-
-
Florida
-
Clearwater, Florida, Forente stater, 00337
- Tilbaketrukket
- Morton Plant Hospital - Bay Care
-
Gainesville, Florida, Forente stater, 32610
- Tilbaketrukket
- University of Florida
-
Jacksonville, Florida, Forente stater, 32256
- Rekruttering
- Cancer Specialists of North Florida
-
Jacksonville, Florida, Forente stater, 32224
- Rekruttering
- Mayo Clinic Florida
-
Jupiter, Florida, Forente stater, 33458
- Rekruttering
- Jupiter Medical Center
-
Miami Beach, Florida, Forente stater, 33140
- Rekruttering
- Mount Sinai Comprehensive Cancer Center
-
Orange City, Florida, Forente stater, 32763
- Tilbaketrukket
- Midland Florida Clinical Research Center, L
-
Orlando, Florida, Forente stater, 32806
- Aktiv, ikke rekrutterende
- Orlando Health
-
Palm Bay, Florida, Forente stater, 32909
- Rekruttering
- Cancer Care Centers of Brevard, Inc
-
Pembroke Pines, Florida, Forente stater, 33028
- Rekruttering
- Memorial Healthcare System
-
Pensacola, Florida, Forente stater, 32504
- Tilbaketrukket
- Sacred Heart Medical Oncology Group
-
Plantation, Florida, Forente stater, 33324
- Rekruttering
- Sylvester Comprehensive Cancer Center
-
Stuart, Florida, Forente stater, 34994
- Tilbaketrukket
- Cleveland Clinic Florida, Martin North Hospital
-
Tampa, Florida, Forente stater, 33614
- Tilbaketrukket
- St. Joseph's Hospital
-
Weston, Florida, Forente stater, 33331
- Tilbaketrukket
- Weston Hospital
-
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Georgia
-
Athens, Georgia, Forente stater, 30607
- Rekruttering
- University Cancer & Blood Center, LLC.
-
Atlanta, Georgia, Forente stater, 30342
- Rekruttering
- Northside Hospital
-
Atlanta, Georgia, Forente stater, 30318
- Rekruttering
- Piedmont Cancer Institute
-
Marietta, Georgia, Forente stater, 30060
- Rekruttering
- Northwest Georgia Oncology Centers, PC
-
Newnan, Georgia, Forente stater, 30265
- Rekruttering
- Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta
-
Valdosta, Georgia, Forente stater, 31602
- Rekruttering
- Pearlman Cancer Center
-
-
Idaho
-
Boise, Idaho, Forente stater, 83712
- Tilbaketrukket
- St Lukes Mountain States Tumor Institute
-
Coeur d'Alene, Idaho, Forente stater, 83814
- Rekruttering
- Kootenai Health
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60612
- Rekruttering
- Rush University Medical Center
-
Chicago, Illinois, Forente stater, 60611
- Rekruttering
- Northwestern Medicine
-
Chicago, Illinois, Forente stater, 60612
- Tilbaketrukket
- University of Illinois
-
Chicago, Illinois, Forente stater, 60637
- Rekruttering
- University of Chicago Medical Center
-
Evanston, Illinois, Forente stater, 60201
- Rekruttering
- NorthShore University Healthsystem
-
Naperville, Illinois, Forente stater, 60540
- Rekruttering
- Edward Hospital
-
River Forest, Illinois, Forente stater, 60305
- Tilbaketrukket
- West Suburban Medical Center- River Forest
-
Skokie, Illinois, Forente stater, 60076
- Tilbaketrukket
- Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore
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Springfield, Illinois, Forente stater, 62702
- Tilbaketrukket
- Springfield Clinic LLP
-
Urbana, Illinois, Forente stater, 61801
- Rekruttering
- Carle Cancer Center
-
-
Indiana
-
Indianapolis, Indiana, Forente stater, 46237
- Rekruttering
- Franciscan Health Indianapolis
-
Indianapolis, Indiana, Forente stater, 46260
- Tilbaketrukket
- Investigative Clinical Research of Indiana, LLC
-
Lafayette, Indiana, Forente stater, 47904
- Tilbaketrukket
- IU Health Arnett Hospital
-
Munster, Indiana, Forente stater, 46321
- Tilbaketrukket
- Franciscan Health Munster
-
-
Iowa
-
Cedar Rapids, Iowa, Forente stater, 52403
- Tilbaketrukket
- Mercy Medical Center
-
Des Moines, Iowa, Forente stater, 50309
- Rekruttering
- Mission Cancer & Blood - John Stoddard Cancer Center
-
Iowa City, Iowa, Forente stater, 52242
- Rekruttering
- University of Iowa Hospitals and Clinics
-
-
Kansas
-
Wichita, Kansas, Forente stater, 67214
- Rekruttering
- Cancer Center of Kansas
-
-
Kentucky
-
Lexington, Kentucky, Forente stater, 40536
- Tilbaketrukket
- University of Kentucky
-
Louisville, Kentucky, Forente stater, 40207
- Rekruttering
- Norton Healthcare, Inc.
-
Paducah, Kentucky, Forente stater, 42003
- Rekruttering
- Mercy Health
-
-
Louisiana
-
Baton Rouge, Louisiana, Forente stater, 70809
- Rekruttering
- Mary Bird Perkins Cancer Center
-
New Orleans, Louisiana, Forente stater, 70112
- Tilbaketrukket
- University Medical Center New Orleans
-
New Orleans, Louisiana, Forente stater, 70122
- Rekruttering
- University Medical Center - New Orleans
-
-
Maine
-
Scarborough, Maine, Forente stater, 04074
- Rekruttering
- New England Cancer Specialists
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21231
- Rekruttering
- Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
-
Baltimore, Maryland, Forente stater, 21215
- Rekruttering
- Sinai Hospital of Baltimore, Inc.
-
Baltimore, Maryland, Forente stater, 21229
- Rekruttering
- St. Agnes Hospital
-
Bethesda, Maryland, Forente stater, 20817
- Tilbaketrukket
- American Oncology Partners of Maryland, PA
-
Frederick, Maryland, Forente stater, 21702
- Rekruttering
- James M Stockman Cancer Institute
-
Towson, Maryland, Forente stater, 21204
- Rekruttering
- Greater Baltimore Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02115
- Rekruttering
- Massachusetts General Hospital
-
Boston, Massachusetts, Forente stater, 02215
- Rekruttering
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, Forente stater, 02215
- Rekruttering
- Dana Farber Cancer Institute
-
Boston, Massachusetts, Forente stater, 02111
- Rekruttering
- Tufts Medical Center
-
Foxborough, Massachusetts, Forente stater, 02035
- Rekruttering
- Dana-Farber Cancer Institute @Foxborough
-
Methuen, Massachusetts, Forente stater, 01844
- Rekruttering
- Dana-Farber Cancer Institude at Merrimack Valley
-
Milford, Massachusetts, Forente stater, 01757
- Rekruttering
- Dana Farber Cancer Institute @ Milford Regional Hospital
-
South Weymouth, Massachusetts, Forente stater, 02190
- Rekruttering
- Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital
-
Springfield, Massachusetts, Forente stater, 01199
- Tilbaketrukket
- Baystate Medical Center Inc.
-
Worcester, Massachusetts, Forente stater, 01655
- Tilbaketrukket
- University of Massachusetts Worcester
-
-
Michigan
-
Detroit, Michigan, Forente stater, 48202
- Tilbaketrukket
- Henry Ford Health System
-
Grand Rapids, Michigan, Forente stater, 49503
- Rekruttering
- Cancer and Hematology Centers of Western Michigan
-
Grosse Pointe Woods, Michigan, Forente stater, 48236
- Tilbaketrukket
- Ascension
-
Royal Oak, Michigan, Forente stater, 48073
- Rekruttering
- William Beaumont Hospital
-
Southfield, Michigan, Forente stater, 48075
- Tilbaketrukket
- Ascension Providence Hospital Southfield Cancer Center
-
Ypsilanti, Michigan, Forente stater, 48197
- Tilbaketrukket
- Trinity Health St. Joseph Mercy Ann Arbor
-
-
Minnesota
-
Maplewood, Minnesota, Forente stater, 55109
- Rekruttering
- Minnesota Oncology Hematology, PA
-
Minneapolis, Minnesota, Forente stater, 55455
- Rekruttering
- University of Minnesota Medical Center, Fairview
-
Minneapolis, Minnesota, Forente stater, 55407
- Rekruttering
- Virginia Piper Cancer Center (Allina Health)
-
Rochester, Minnesota, Forente stater, 55905
- Rekruttering
- Mayo Clinic Rochester
-
Saint Louis Park, Minnesota, Forente stater, 55426
- Rekruttering
- Metro Minnesota Community Oncology
-
-
Missouri
-
St Louis, Missouri, Forente stater, 63110
- Rekruttering
- Washington University School of Medicine
-
St Louis, Missouri, Forente stater, 63141
- Tilbaketrukket
- Mercy Hospital
-
St Louis, Missouri, Forente stater, 63131
- Tilbaketrukket
- Baptist Clinical Research Institute
-
-
Nebraska
-
Hastings, Nebraska, Forente stater, 68901
- Aktiv, ikke rekrutterende
- Mary Lanning Healthcare - Morrison Cancer Center
-
Omaha, Nebraska, Forente stater, 68114
- Rekruttering
- Oncology Hematology West - Methodist
-
Omaha, Nebraska, Forente stater, 68124
- Rekruttering
- Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)
-
-
Nevada
-
Las Vegas, Nevada, Forente stater, 89169
- Tilbaketrukket
- Comprehensive Cancer Centers of Nevada
-
Reno, Nevada, Forente stater, 89511
- Tilbaketrukket
- Cancer Care & Hematology Specialists
-
-
New Jersey
-
East Brunswick, New Jersey, Forente stater, 08816
- Rekruttering
- Regional Cancer Care Associates LLC
-
Flemington, New Jersey, Forente stater, 08822
- Rekruttering
- Hunterdon Medical Center
-
Florham Park, New Jersey, Forente stater, 07932
- Tilbaketrukket
- Summit Medical Group, P.A.
-
New Brunswick, New Jersey, Forente stater, 08901
- Rekruttering
- Rutgers Health
-
Summit, New Jersey, Forente stater, 07901
- Rekruttering
- Overlook Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Forente stater, 87131
- Rekruttering
- University of New Mexico
-
Farmington, New Mexico, Forente stater, 87401
- Rekruttering
- San Juan Oncology Associates
-
-
New York
-
Amsterdam, New York, Forente stater, 12010
- Tilbaketrukket
- New York Oncology Hematology (NYOH)
-
Buffalo, New York, Forente stater, 14263
- Tilbaketrukket
- Roswell Park Cancer Institute
-
East Syracuse, New York, Forente stater, 13057
- Rekruttering
- Hematology Oncology Associates of Central New York, PC
-
Lake Success, New York, Forente stater, 11042
- Rekruttering
- Northwell Health
-
New York, New York, Forente stater, 10016
- Rekruttering
- Laura and Isaac Perlmutter Cancer Canter
-
Rochester, New York, Forente stater, 14618
- Rekruttering
- Lipson Cancer Institute - Linden Oaks
-
Shirley, New York, Forente stater, 11967
- Rekruttering
- New York Cancer and Blood Specialists
-
Stony Brook, New York, Forente stater, 11794
- Rekruttering
- Stony Brook Medicine
-
Syracuse, New York, Forente stater, 13210
- Rekruttering
- SUNY Upstate Medical University
-
The Bronx, New York, Forente stater, 10467
- Tilbaketrukket
- Montefiore Medical Center
-
Westbury, New York, Forente stater, 11590
- Tilbaketrukket
- Clinical Research Alliance
-
White Plains, New York, Forente stater, 10601
- Rekruttering
- White Plains Hospital Physician Associates
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater, 27514
- Rekruttering
- Lineberger Comprehensive Cancer Center
-
Charlotte, North Carolina, Forente stater, 28204
- Rekruttering
- Novant Health Cancer Institute - Elizabeth (Breast)
-
Durham, North Carolina, Forente stater, 27710
- Rekruttering
- Duke Cancer Institute
-
Greensboro, North Carolina, Forente stater, 27403
- Rekruttering
- Cone Health Medical Group (Moses Cone Health System)
-
Greenville, North Carolina, Forente stater, 27834
- Tilbaketrukket
- East Carolina University Health Medical Center
-
Pinehurst, North Carolina, Forente stater, 28374
- Tilbaketrukket
- FirstHealth Outpatient Cancer Center
-
Raleigh, North Carolina, Forente stater, 27607
- Tilbaketrukket
- UNC Rex Cancer Center
-
Rocky Mount, North Carolina, Forente stater, 27804
- Tilbaketrukket
- UNC Nash Cancer Center
-
Winston-Salem, North Carolina, Forente stater, 27157
- Rekruttering
- Atrium Health Wake Forest Baptist
-
-
Ohio
-
Cincinnati, Ohio, Forente stater, 45242
- Rekruttering
- Oncology Hematology Care, Inc.
-
Cincinnati, Ohio, Forente stater, 45220
- Rekruttering
- Good Samaritan Hospital
-
Columbus, Ohio, Forente stater, 43214
- Rekruttering
- Ohio Health Research Institute
-
Columbus, Ohio, Forente stater, 43221
- Rekruttering
- Anita Stewart Oncology Center
-
Columbus, Ohio, Forente stater, 43212
- Rekruttering
- Ohio State University CRS
-
Columbus, Ohio, Forente stater, 43215
- Tilbaketrukket
- Columbus NCORP
-
Toledo, Ohio, Forente stater, 43623
- Tilbaketrukket
- Toledo Clinic Cancer Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater, 73104
- Tilbaketrukket
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Bend, Oregon, Forente stater, 97701
- Rekruttering
- St. Charles Health System, Inc. DBA St. Charles Medical Center
-
Corvallis, Oregon, Forente stater, 97330
- Rekruttering
- Samaritan Hospital
-
Eugene, Oregon, Forente stater, 97401
- Rekruttering
- Willamette Valley Cancer Institute and Research Center
-
Medford, Oregon, Forente stater, 97504
- Tilbaketrukket
- Asante Rogue Regional Medical Center
-
Portland, Oregon, Forente stater, 97239
- Rekruttering
- Oregon Health & Science University
-
Portland, Oregon, Forente stater, 97213
- Tilbaketrukket
- Providence Cancer Institute - Oncology Clinical Trials
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, Forente stater, 18015
- Tilbaketrukket
- Saint Luke's University Hospital
-
Lancaster, Pennsylvania, Forente stater, 17601
- Rekruttering
- Lancaster General Health
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- University of Pennsylvania Abramson Cancer Center
-
Pittsburgh, Pennsylvania, Forente stater, 15213
- Rekruttering
- UPMC Magee-Womens Hospital
-
Sayre, Pennsylvania, Forente stater, 18840
- Rekruttering
- Guthrie Clinical Research
-
West Reading, Pennsylvania, Forente stater, 19611
- Tilbaketrukket
- Reading Hospital and Medical Center
-
Wynnewood, Pennsylvania, Forente stater, 19106
- Rekruttering
- Lankenau Medical Center
-
York, Pennsylvania, Forente stater, 17403
- Rekruttering
- Cancer Care Associates of York
-
-
Rhode Island
-
Providence, Rhode Island, Forente stater, 02905
- Rekruttering
- Providence Health
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29425
- Rekruttering
- Medical University of South Carolina
-
Greenville, South Carolina, Forente stater, 29607
- Rekruttering
- St. Francis Cancer Center
-
Spartanburg, South Carolina, Forente stater, 29303
- Rekruttering
- Spartanburg Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Forente stater, 57701
- Rekruttering
- Monument Health Cancer Care Institute
-
Sioux Falls, South Dakota, Forente stater, 57105
- Rekruttering
- Avera Cancer Institute
-
-
Tennessee
-
Kingsport, Tennessee, Forente stater, 37660
- Tilbaketrukket
- Ballad Health Cancer Care - Kingsport
-
Knoxville, Tennessee, Forente stater, 37920
- Rekruttering
- University of Tennessee
-
Knoxville, Tennessee, Forente stater, 37909
- Tilbaketrukket
- Center for Biomedical Research, LLC
-
-
Texas
-
Abilene, Texas, Forente stater, 79601
- Tilbaketrukket
- Hendrick Health System
-
Austin, Texas, Forente stater, 78731
- Rekruttering
- Texas Oncology
-
El Paso, Texas, Forente stater, 79902
- Rekruttering
- Texas Oncology
-
Houston, Texas, Forente stater, 77030
- Rekruttering
- MD Anderson Cancer Center
-
Lubbock, Texas, Forente stater, 79410
- Tilbaketrukket
- Joe Arrington Cancer Research and Treatment Center
-
San Antonio, Texas, Forente stater, 78240
- Rekruttering
- Texas Oncology
-
-
Utah
-
Salt Lake City, Utah, Forente stater, 84112
- Rekruttering
- Huntsman Cancer Institute
-
-
Virginia
-
Charlottesville, Virginia, Forente stater, 22908
- Rekruttering
- University of Virginia
-
Fairfax, Virginia, Forente stater, 22031
- Rekruttering
- Inova Fairfax Hospital
-
Midlothian, Virginia, Forente stater, 23114
- Rekruttering
- Bon Secours Cancer Institute at St. Francis
-
Richmond, Virginia, Forente stater, 23298
- Tilbaketrukket
- Virginia Commonwealth University Medical Center
-
Wytheville, Virginia, Forente stater, 24382
- Rekruttering
- Oncology and Hematology Associates of Southwest Virginia, Inc
-
-
Washington
-
Lacey, Washington, Forente stater, 98503
- Rekruttering
- Providence Regional Cancer System
-
Puyallup, Washington, Forente stater, 98372
- Rekruttering
- MultiCare Regional Cancer Center - Tacoma
-
Puyallup, Washington, Forente stater, 98373
- Rekruttering
- Northwest Medical Specialties, PLLC
-
Renton, Washington, Forente stater, 98055
- Tilbaketrukket
- University of Washington
-
Spokane, Washington, Forente stater, 99208
- Tilbaketrukket
- Medical Oncology Associates
-
-
West Virginia
-
Morgantown, West Virginia, Forente stater, 26505
- Rekruttering
- West Virginia University Hospital
-
-
Wisconsin
-
Appleton, Wisconsin, Forente stater, 54911
- Tilbaketrukket
- ThedaCare Regional Cancer Center
-
Franklin, Wisconsin, Forente stater, 53132
- Rekruttering
- Ascension St. Francis Reiman Cancer Center
-
Green Bay, Wisconsin, Forente stater, 54303
- Tilbaketrukket
- HSHS Saint Mary's Hospital Medical Center - Green Bay
-
Madison, Wisconsin, Forente stater, 53792
- Tilbaketrukket
- University of Wisconsin
-
-
-
-
-
Amiens, Frankrike, 80000
- Rekruttering
- CHU Amiens Picardie
-
Chambray-lès-Tours, Frankrike, 37170
- Rekruttering
- Pôle Santé Léonard De Vinci - ROC37
-
Dijon, Frankrike, 21000
- Rekruttering
- Institut de Cancerologie de Bourgogne
-
Le Mans, Frankrike, 72000
- Rekruttering
- Clinique Victor Hugo
-
Limoges, Frankrike, 87042
- Rekruttering
- chu de Limoges
-
Loire Atlantique, Frankrike, 44 805
- Rekruttering
- Institut de Cancérologie de l'Ouest (ICO) - St Herblain
-
Lyon, Frankrike, 69008
- Rekruttering
- Hôpital Privé Jean Mermoz
-
Nancy, Frankrike, 54000
- Rekruttering
- Centre D'Oncologie de Gentilly
-
Nantes, Frankrike, 44277
- Rekruttering
- L'Hôpital Privé du Confluent
-
Nîmes, Frankrike, 30029
- Rekruttering
- CHU de Nimes
-
Plérin, Frankrike, 22190
- Rekruttering
- Hopital Privé des Côtes d'Armor - Centre CARIO-HPCA
-
Poitiers, Frankrike, 86021
- Rekruttering
- CHU de Poitiers, 2 Rue de la Milétrie
-
Rennes, Frankrike, 35042
- Rekruttering
- Centre Eugène Marquis
-
Strasbourg, Frankrike, 67000
- Aktiv, ikke rekrutterende
- Clinique Ste Anne Strasbourg_Oncologie Liberale
-
Toulouse, Frankrike, 31059
- Rekruttering
- Oncopole Claudius Regaud - IUCT-O
-
Villejuif, Frankrike, 94800
- Rekruttering
- Gustave Roussy
-
-
-
-
-
Dublin, Irland, D07 R2WY
- Rekruttering
- Mater Misericordiae University Hospital
-
Dublin, Irland, D09V2N0
- Rekruttering
- Beaumont Hospital
-
Dublin, Irland, D08NH41
- Rekruttering
- St James's Hospital
-
Limerick, Irland, V94 F858
- Har ikke rekruttert ennå
- University Hospital Limerick
-
Wilton, Irland, T12 DC4A
- Rekruttering
- Cork University Hospital
-
-
-
-
-
Bari, Italia, 70124
- Rekruttering
- IRCCS Istituto Tumori "Giovanni Paolo II"
-
Bologna, Italia, 40138
- Rekruttering
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
-
Florence, Italia, 50134
- Rekruttering
- Azienda Ospedaliera Universitaria Careggi
-
Genova, Italia, 16132
- Rekruttering
- IRCCS AOM Ospedale Policlinico San Martino
-
Meldola, Italia, 47014
- Rekruttering
- Istituto Romagnolo Per Lo Studio Dei Tumori (IRST) 'Dino Amadori? IRCCS
-
Milan, Italia, 20133
- Rekruttering
- Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano
-
Misterbianco, Italia, 95125
- Rekruttering
- Humanitas Istituto Clinico Catanese
-
Modena, Italia, 41125
- Rekruttering
- AOU Modena
-
Naples, Italia, 80131
- Rekruttering
- IRCCS Fondazione G. Pascale
-
Naples, Italia, 80131
- Aktiv, ikke rekrutterende
- AOU Federico II
-
Roma, Italia, 168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
-
Rome, Italia, 00128
- Rekruttering
- Fondazione Policlinico Universitario Campus Bio-Medico di Roma
-
Rozzano, Italia, 20089
- Aktiv, ikke rekrutterende
- ASST Papa Giovanni XXIII
-
Torino, Italia, 10123
- Rekruttering
- AOU Città della Salute e della Scienza di Torino
-
Trento, Italia, 38122
- Rekruttering
- Ospedale Santa Chiara
-
-
-
-
-
Aichi, Japan, 464-8681
- Rekruttering
- Aichi Cancer Center
-
Chiba, Japan, 260-8717
- Rekruttering
- Chiba Cancer Center
-
Sapporo, Japan, 003-0804
- Rekruttering
- National Hospital Organization Hokkaido Cancer Center
-
Tokyo, Japan, 135-8550
- Rekruttering
- The Cancer Institute Hospital of JFCR
-
-
-
-
-
A Coruña, Spania, 15006
- Rekruttering
- Medical Oncology Unit. A Coruña University Hospital
-
Badalona, Spania, 08916
- Rekruttering
- ICO Badalona - Hospital Germans Trias I Pujol
-
Barakaldo, Spania, 48903
- Rekruttering
- Hospital Universitary of Cruces
-
Barcelona, Spania, 08036
- Rekruttering
- Hospital Clinic de Barcelona
-
Barcelona, Spania, 8041
- Rekruttering
- Hospital de la Santa Creu i Sant Pau
-
Barcelona, Spania, 8003
- Rekruttering
- Hospital del Mar
-
Castellon, Spania, 12002
- Rekruttering
- Consorcio Hospitalario Provincial de Castellón
-
Cáceres, Spania, 10003
- Rekruttering
- Hospital Universitario San Pedro de Alcántara
-
Córdoba, Spania, 14004
- Rekruttering
- Hospital Reina Sofia
-
Donostia / San Sebastian, Spania, 20014
- Rekruttering
- Hospital Donostia
-
Elche, Spania, 03203
- Rekruttering
- Hospital General Universitario De Elche
-
Fuenlabrada, Spania, 28942
- Rekruttering
- Hospital Universitario de Fuenlabrada
-
Galdakao, Spania, 48960
- Rekruttering
- Hospital Galdakao
-
Granada, Spania, 18014
- Rekruttering
- Hospital Universitario Virgen de las Nieves
-
Granada, Spania, 18016
- Rekruttering
- Hospital Universitario Clínico San Cecilio
-
Jaén, Spania, 23007
- Rekruttering
- Hospital Universitario de Jaen
-
León, Spania, 24008
- Rekruttering
- H. León
-
Lleida, Spania, 25198
- Rekruttering
- Hospital Arnau de Vilanova
-
Madrid, Spania, 28007
- Rekruttering
- Hospital General Universitario Gregorio Maranon
-
Madrid, Spania, 28007
- Rekruttering
- Hospital Beata María Ana
-
Manresa, Spania, 08242
- Rekruttering
- Althaia Xarxa Assistencial de Manresa
-
Murcia, Spania, 30008
- Rekruttering
- Hospital General Univers
-
Murcia, Spania, 30008
- Tilbaketrukket
- Hospital Universitario Morales Meseguer
-
Málaga, Spania, 29010
- Rekruttering
- Hospital Universitario Virgen de la Victoria
-
Málaga, Spania, 29011
- Rekruttering
- Hosp. Mat-Inf. Carlos Haya
-
Pamplona, Spania, 31008
- Rekruttering
- Clínica Universidad de Navarra - Madrid
-
Reus, Spania, 43204
- Rekruttering
- Hospital Universitari Sant Joan de Reus
-
Sabadell, Spania, 08028
- Rekruttering
- Hospital Parc Tauli
-
San Cristóbal de La Laguna, Spania, 38320
- Rekruttering
- Hospital Universitario de Canarias
-
Santander, Spania, 39008
- Rekruttering
- HU Marqués de Valdecilla
-
Seville, Spania, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena
-
Seville, Spania, 41010
- Rekruttering
- Hospital Quironsalud Sagrado Corazón
-
Toledo, Spania, 45007
- Rekruttering
- Hospital de Toledo
-
Valencia, Spania, 46010
- Rekruttering
- Hospital Clínico Universitario de Valencia
-
Valencia, Spania, 46014
- Rekruttering
- Hospital Clínico Universitario de Valencia
-
Valladolid, Spania, 47003
- Rekruttering
- Hospital Clinico Universitario de Valladolid
-
Zaragoza, Spania, 50009
- Rekruttering
- Isabel la Catolica nº 1-3
-
-
-
-
-
Cottingham, Storbritannia, HU165JQ
- Rekruttering
- Hull University Teaching Hospitals NHS Trust
-
Edgbaston, Storbritannia, B152TH
- Har ikke rekruttert ennå
- University Hospitals Birmingham NHS Foundation Trust
-
Liverpool, Storbritannia, L7 8YA
- Rekruttering
- The Clatterbridge Cancer Centre NHS Foundation Trust
-
London, Storbritannia, SE1 9RT
- Rekruttering
- Guy's Hospital
-
London, Storbritannia, EC1M 6QB
- Rekruttering
- Barts Health NHS Trust
-
London, Storbritannia, SW10 9NH
- Rekruttering
- Royal Marsden Hospital
-
Manchester, Storbritannia, M20 4BX
- Rekruttering
- The Christie NHS Foundation Trust
-
Northwood, Storbritannia, HA6 2RN
- Rekruttering
- East and North Hertfordshire NHS Trust
-
Taunton, Storbritannia, TA1 5DA
- Rekruttering
- Taunton and Somerset NHS Foundation Trust
-
York, Storbritannia, YO31 8HE
- Har ikke rekruttert ennå
- York Teaching Hospital NHS Foundation Trust
-
-
-
-
-
Chungcheongnam-do, Sør -Korea, 31151
- Rekruttering
- Soonchunhyang University Cheonan Hospital
-
Daegu, Sør -Korea, 41404
- Rekruttering
- Kyungpook National University Chilgok Hospital
-
Gyeonggi-do, Sør -Korea, 13620
- Rekruttering
- Seoul National University Bundang Hospital
-
Seodaemun-gu, Sør -Korea, 3722
- Rekruttering
- Severance Hospital
-
Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center
-
Seoul, Sør -Korea, 02841
- Rekruttering
- Korea University Anam Hospital
-
Seoul, Sør -Korea, 6351
- Rekruttering
- Samsung Medical Center
-
Seoul, Sør -Korea
- Rekruttering
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Seoul, Sør -Korea, 06273
- Rekruttering
- Gangnam Severance Hospital
-
Seoul, Sør -Korea, 3080
- Rekruttering
- Seoul National University Hospital
-
-
-
-
-
Augsburg, Tyskland, 86150
- Rekruttering
- Hämatologie-Onkologie im Zentrum MVZ GmbH
-
Berlin, Tyskland, 13125
- Aktiv, ikke rekrutterende
- Schwanebecker Chaussee 50
-
Berlin, Tyskland, 13597
- Rekruttering
- Möllendorffstr. 52, 10367 Berlin 2. Behandlungsstandort: Markt 2-3, 13597 Berlin
-
Bielefeld, Tyskland, 33604
- Rekruttering
- Teutoburger Str. 60
-
Bottrop, Tyskland, 46236
- Rekruttering
- Josef-Albers-Str.70
-
Braunschweig, Tyskland, 38100
- Rekruttering
- Studien GbR Braunschweig
-
Bremen, Tyskland, 28209
- Rekruttering
- Hämato-Onkologische Praxis im Medicum
-
Bremen, Tyskland, 28205
- Tilbaketrukket
- Klinikum Bremen-Mitte
-
Cologne, Tyskland, 50935
- Rekruttering
- St. Elisabeth Krankenhaus GmbH
-
Dortmund, Tyskland, 44137
- Rekruttering
- St. Johannes Hospital
-
Dresden, Tyskland, 01307
- Rekruttering
- Fetscherstraße ,74
-
Düsseldorf, Tyskland, 40235
- Rekruttering
- Kostara Gyn. Oncology Clinic Research UG
-
Erlangen, Tyskland, 91054
- Rekruttering
- Universitätsstraße, 21-23
-
Essen, Tyskland, 45136
- Rekruttering
- Henricistraße 92, 45136 Essen, Germany
-
Esslingen am Neckar, Tyskland, 73730
- Rekruttering
- Klinikum Esslingen
-
Frankfurt, Tyskland, 60431
- Rekruttering
- Wilhelm-Epstein-Str. 4
-
Frankfurt am Main, Tyskland, 65929
- Rekruttering
- Gotenstraße 6-8
-
Freiburg im Breisgau, Tyskland, 79106
- Rekruttering
- Hugstetter Str. 55
-
Gelsenkirchen, Tyskland, 45879
- Rekruttering
- Munckelstrasse 27
-
Georgsmarienhütte, Tyskland, 49124
- Rekruttering
- MVZ II der Niels Stensen Kliniken
-
Gera, Tyskland, 7548
- Rekruttering
- Straße des Friedens 122
-
Hamburg, Tyskland, 20357
- Rekruttering
- Moorkamp 2-6
-
Hamburg, Tyskland, 20259
- Rekruttering
- Hohe Weide 17b
-
Jena, Tyskland, 07447
- Rekruttering
- Am Klinikum 1
-
Karlsruhe, Tyskland, 76137
- Aktiv, ikke rekrutterende
- Edgar-von-Gierke-Straße 2
-
Kassel, Tyskland, 34117
- Rekruttering
- Elisabeth Krankenhaus Brustzentrum
-
Kiel, Tyskland, 24105
- Rekruttering
- Arnold-Heller-Str. 3 Haus C
-
Koblenz, Tyskland, 56068
- Rekruttering
- InVO - Institut für Versorgungsforschung in der Onkologie GbR / Praxis für Hämatologie und Onkologie
-
Krefeld, Tyskland, 47805
- Rekruttering
- Lutherplatz 40
-
Langen, Tyskland, 63225
- Rekruttering
- Fachärztezentrum Langen
-
Leipzig, Tyskland, 4277
- Rekruttering
- Biedermannstrasse 84
-
Leipzig, Tyskland, 04103
- Rekruttering
- Liebigstraße 20
-
Mannheim, Tyskland, 68167
- Rekruttering
- Universitätsklinikum Mannheim
-
Munich, Tyskland, 80637
- Rekruttering
- Taxisstrasse 3
-
Mühlhausen, Tyskland, 99974
- Tilbaketrukket
- Bei der Marienkirche 6
-
Münster, Tyskland, 48149
- Rekruttering
- Albert-Schweitzer-Campus 1, Building A1,
-
Offenbach, Tyskland, 63069
- Rekruttering
- Starkenburgring 66, 63069 Offenbach
-
Oldenburg, Tyskland, 26133
- Rekruttering
- Rahel-Straus-Straße 10
-
Paderborn, Tyskland, 33098
- Rekruttering
- Husenerstr. 81
-
Potsdam, Tyskland, 14467
- Rekruttering
- Charlottenstraße 72
-
Ravensburg, Tyskland, 88212
- Rekruttering
- Elisabethenstr. 19, 88212 Ravensburg
-
Rostock, Tyskland, 18059
- Rekruttering
- Südring 81
-
Schwerin, Tyskland, 19055
- Rekruttering
- Wismarsche Strasse 393-397
-
Stade, Tyskland, 21680
- Aktiv, ikke rekrutterende
- Harsefelderstraße 8
-
Stuttgart, Tyskland, 70199
- Aktiv, ikke rekrutterende
- Böheimstr. 37
-
Traunstrein, Tyskland, 83278
- Rekruttering
- Schierghoferstrasse 1
-
Tübingen, Tyskland, 72076
- Rekruttering
- Calwerstrasse 7
-
Ulm, Tyskland, 89075
- Rekruttering
- Prittwitzstr. 43
-
Wiesbaden, Tyskland, 65189
- Rekruttering
- Beethovenstrasse 20
-
Witten, Tyskland, 58455
- Har ikke rekruttert ennå
- Marienplatz 2
-
Worms, Tyskland, 67550
- Rekruttering
- Klinikum Worms Frauenklinik
-
Wuppertal, Tyskland, 42283
- Rekruttering
- Helios University Hospital University Witten/Herdecke
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Key Inclusion Criteria:
-
Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:
- TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)).
-
Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.
-
Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.
-
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
-
Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered prior to starting study treatment.
-
Adequate organ function.
Key Exclusion Criteria:
- Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
- Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment.
- Evidence of recurrent disease following preoperative therapy and surgery.
- Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.
- Individuals with germline breast cancer gene (BRCA) mutations.
- Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of < 50%
- Active serious infections requiring anti-microbial therapy.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Sacituzumab govitecan-hziy (SG) + Pembrolizumab
Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death. |
Administered intravenously
Andre navn:
Administered intravenously
Andre navn:
|
|
Aktiv komparator: Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine
Participants will receive one of the following TPC regimens determined prior to randomization:
Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death. |
Administered intravenously
Andre navn:
Tablets administered orally
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Invasive Disease-free Survival (iDFS)
Tidsramme: Up to 60 months
|
iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer. |
Up to 60 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prosentandel av deltakere som opplever behandlingsfremkallende bivirkninger (TEAE)
Tidsramme: Første dosedato opptil 38 måneder pluss 30 dager
|
Første dosedato opptil 38 måneder pluss 30 dager
|
|
|
Prosentandel av deltakere som opplever laboratorieavvik
Tidsramme: Første dosedato opptil 38 måneder pluss 30 dager
|
Første dosedato opptil 38 måneder pluss 30 dager
|
|
|
Overall Survival (OS)
Tidsramme: Up to 96 months
|
OS is defined as the time from the date of randomization until death due to any cause. |
Up to 96 months
|
|
Distant Disease-free Survival (dDFS)
Tidsramme: Up to 60 months
|
dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer. |
Up to 60 months
|
|
Recurrence-free Survival (RFS)
Tidsramme: Up to 60 months
|
RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence. |
Up to 60 months
|
|
Time to Worsening (TTW) of Quality of Life (QoL) Based on Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) Trial Outcome Index (TOI) Scores
Tidsramme: Up to 60 months
|
TTW of FACT-B TOI scores will be analyzed for each index, the TTW of FACT-B scores will be measured from the randomization date and to the time the participants first experienced a first score of worsening. |
Up to 60 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Gilead Study Director, Gilead Sciences
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. desember 2022
Primær fullføring (Antatt)
1. juni 2027
Studiet fullført (Antatt)
1. august 2031
Datoer for studieregistrering
Først innsendt
21. november 2022
Først innsendt som oppfylte QC-kriteriene
21. november 2022
Først lagt ut (Faktiske)
1. desember 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Hudsykdommer
- Bryst sykdommer
- Brystneoplasmer
- Hud- og bindevevssykdommer
- Trippel negative brystneoplasmer
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Nukleinsyrer, nukleotider og nukleosider
- Deoxycytidine
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Nukleosider
- Uracil
- Pyrimidinoner
- Deoxyribonucleosides
- Fluorouracil
- Capecitabin
- pembrolizumab
- Sacituzumab Govitecan
Andre studie-ID-numre
- GS-US-595-6184
- 2024-512279-10 (Annen identifikator: European Medicines Agency)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .