Undersøgelse af Sacituzumab Govitecan-hziy og Pembrolizumab versus behandling af lægens valg hos patienter med tredobbelt negativ brystkræft, som har resterende invasiv sygdom efter operation og neoadjuverende terapi
3. november 2026 opdateret af: Gilead Sciences
Et randomiseret, åbent, fase 3-studie af adjuverende Sacituzumab Govitecan og Pembrolizumab versus behandling af lægens valg hos patienter med tredobbelt negativ brystkræft, som har resterende invasiv sygdom efter operation og neoadjuverende 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1514
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Gilead Clinical Study Information Center
- Telefonnummer: 1-833-445-3230 (GILEAD-0)
- E-mail: GileadClinicalTrials@gilead.com
Studiesteder
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New South Wales
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Campbelltown, New South Wales, Australien, 2560
- Rekruttering
- Macarthur Cancer Therapy Centre, Campbelltown Hospital
-
Darlinghurst, New South Wales, Australien, 2010
- Trukket tilbage
- Kinghorn Cancer Centre
-
Gateshead, New South Wales, Australien, 2290
- Rekruttering
- Lake Macquarie Private Hospital
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Port Macquarie, New South Wales, Australien, 2444
- Rekruttering
- Port Macquarie Base Hospital
-
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Queensland
-
Cairns, Queensland, Australien, 4870
- Rekruttering
- Cairns Hospital
-
Douglass, Queensland, Australien, 4818
- Rekruttering
- Townsville University Hospital
-
Woolloongabba, Queensland, Australien, 4102
- Rekruttering
- Princess Alexandra Hospital
-
-
South Australia
-
Adelaide, South Australia, Australien, 5000
- Rekruttering
- Cancer Research SA
-
-
Victoria
-
Bendigo, Victoria, Australien, 3551
- Rekruttering
- Bendigo Health
-
Clayton, Victoria, Australien, 3168
- Rekruttering
- Monash Medical Centre
-
-
Western Australia
-
Murdoch, Western Australia, Australien, 6150
- Rekruttering
- Fiona Stanley Hospital
-
-
-
-
-
Anderlecht, Belgien, 1070
- Rekruttering
- Institut Jules Bordet
-
Brasschaat, Belgien, 2930
- Aktiv, ikke rekrutterende
- AZ Klina
-
Brussels, Belgien, 1160
- Rekruttering
- Chirec Delta Hospital
-
Gilly, Belgien, 6060
- Aktiv, ikke rekrutterende
- Grand Hopital de Charleroi asbl (GHdC)
-
Hasselt, Belgien, 3500
- Rekruttering
- Jessa Ziekenhuis
-
Leuven, Belgien, 3000
- Rekruttering
- UZ Leuven
-
Liège, Belgien, 4000
- Rekruttering
- Clinique CHC MontLégia
-
Roeselare, Belgien, 8800
- Rekruttering
- AZ Delta vzw
-
Sint-Niklaas, Belgien, 9100
- Aktiv, ikke rekrutterende
- AZ Vitaz
-
Wilrijk, Belgien, 2610
- Rekruttering
- Ziekenhuls aan de Stroom vzw (ZAS vzw), ZAS Augustinus
-
-
-
-
-
Brasília, Brasilien, 71681-603
- Rekruttering
- St. de Habitações Individuais Sul QI 15 - Lago Sul, Brasília - DF, Brasil
-
Curitiba, Brasilien, 80510-130
- Rekruttering
- Rua Myltho Anselmo da Silva, 870 - Mercês, Curitiba - PR, CEP 80510-130
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Curitiba, Brasilien, 80040-170
- Rekruttering
- Rua Padre Germano Mayer, 1949, Hugo Lange, Curitiba, Paraná
-
Ijuí, Brasilien, 98700-000
- Rekruttering
- Oncosite
-
Itajaí, Brasilien, 88300-000
- Rekruttering
- R. Aderbal Ramos da Silva, 148 - Centro, Itajaí - SC, 88300-000, Brasil
-
Natal, Brasilien, 59062-200
- Rekruttering
- Av. Miguel Castro, 1355, Nossa Senhora de Nazaré, Natal/RN
-
Porto Alegre, Brasilien, 90020-090
- Rekruttering
- Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, , Brasil
-
Porto Alegre, Brasilien, 90470-340
- Rekruttering
- Av. Soledad, 569, sala 1103, Três Figueiras, CEP 90470-340
-
Porto Alegre, Brasilien, 90610-000
- Rekruttering
- Av. Ipiranga 6690
-
Recife, Brasilien, 50070-480
- Aktiv, ikke rekrutterende
- Hospital Esperança SA
-
Recife, Brasilien, 52011-906
- Rekruttering
- Instituto Santa Joana Recife de Ensino e Pesquisa
-
Rio de Janiero, Brasilien, 20560-121
- Rekruttering
- Instituto D'Or de Pesquisa e Ensino - RJ
-
Salvador, Brasilien, 40170-110
- Rekruttering
- Av. Milton Santos, 123 - Ondina, Salvador - BA, , Brasil
-
Salvador, Brasilien, 41950-640
- Aktiv, ikke rekrutterende
- AMO Clinic - Rio Vermelho
-
São Paulo, Brasilien, 01317-000
- Rekruttering
- Av. Brigadeiro Luís Antônio 733, loja 8
-
São Paulo, Brasilien, 01323-001
- Rekruttering
- Martiiano de Carvalho 965
-
São Paulo, Brasilien, 01509-010
- Rekruttering
- CIPE Centro Internacional de Pesquisa; A.C. Camargo Cancer Center
-
São Paulo, Brasilien, 01308-060
- Aktiv, ikke rekrutterende
- Hospital Sirio Libanês - SP
-
São Paulo, Brasilien, 04501-000
- Aktiv, ikke rekrutterende
- Instituto D'Or de Pesquisa e Ensino SP
-
Teresina, Brasilien, 60449-200
- Rekruttering
- Rua Gardênia, 710, Edifício Prime, 4º andar, Bairro Jóquei, Teresina - PI, CEP 60449-200
-
-
-
-
-
Cottingham, Det Forenede Kongerige, HU165JQ
- Rekruttering
- Hull University Teaching Hospitals NHS Trust
-
Edgbaston, Det Forenede Kongerige, B152TH
- Ikke rekrutterer endnu
- University Hospitals Birmingham NHS Foundation Trust
-
Liverpool, Det Forenede Kongerige, L7 8YA
- Rekruttering
- The Clatterbridge Cancer Centre NHS Foundation Trust
-
London, Det Forenede Kongerige, SE1 9RT
- Rekruttering
- Guy's Hospital
-
London, Det Forenede Kongerige, EC1M 6QB
- Rekruttering
- Barts Health NHS Trust
-
London, Det Forenede Kongerige, SW10 9NH
- Rekruttering
- Royal Marsden Hospital
-
Manchester, Det Forenede Kongerige, M20 4BX
- Rekruttering
- The Christie NHS Foundation Trust
-
Northwood, Det Forenede Kongerige, HA6 2RN
- Rekruttering
- East and North Hertfordshire NHS Trust
-
Taunton, Det Forenede Kongerige, TA1 5DA
- Rekruttering
- Taunton and Somerset NHS Foundation Trust
-
York, Det Forenede Kongerige, YO31 8HE
- Ikke rekrutterer endnu
- York Teaching Hospital NHS Foundation Trust
-
-
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35243
- Rekruttering
- Alabama Oncology
-
Huntsville, Alabama, Forenede Stater, 35805
- Rekruttering
- Clearview Cancer Institute
-
-
Arizona
-
Glendale, Arizona, Forenede Stater, 85304
- Rekruttering
- Palo Verde Hematology Oncology
-
Phoenix, Arizona, Forenede Stater, 85054
- Trukket tilbage
- Mayo Clinic Hospital
-
Prescott Valley, Arizona, Forenede Stater, 86314
- Trukket tilbage
- Arizona Oncology Associates
-
-
California
-
Berkeley, California, Forenede Stater, 94704
- Rekruttering
- Alta Bates Summit Medical Center
-
Clovis, California, Forenede Stater, 93611
- Trukket tilbage
- Community Cancer Institute
-
Downey, California, Forenede Stater, 90241
- Rekruttering
- PIH Health Whittier Hospital
-
Fountain Valley, California, Forenede Stater, 92708
- Aktiv, ikke rekrutterende
- Compassionate Cancer Care Medical Group - Inc
-
Los Angeles, California, Forenede Stater, 90033
- Trukket tilbage
- USC Norris Comprehensive Cancer Center
-
Los Angeles, California, Forenede Stater, 90048
- Rekruttering
- Cedars-Sinai Cancer at Beverly Hills
-
Los Angeles, California, Forenede Stater, 90017
- Aktiv, ikke rekrutterende
- Los Angeles Cancer Network
-
Newport Beach, California, Forenede Stater, 92663
- Rekruttering
- Hoag Memorial Hospital Presbyterian
-
Redlands, California, Forenede Stater, 92373
- Trukket tilbage
- Emad Ibrahim, MD, INC
-
Sacramento, California, Forenede Stater, 95816
- Rekruttering
- Sutter Institute for Medical Research
-
San Francisco, California, Forenede Stater, 94143
- Rekruttering
- UCSF Medical Center
-
San Francisco, California, Forenede Stater, 94143
- Rekruttering
- City of Hope (Duarte)
-
Santa Barbara, California, Forenede Stater, 93105
- Rekruttering
- Sansum Clinic
-
Stockton, California, Forenede Stater, 95204
- Rekruttering
- Stockton Hematology Oncology Medical Group
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045
- Trukket tilbage
- University of Colorado Cancer Center
-
-
Connecticut
-
Danbury, Connecticut, Forenede Stater, 06810
- Trukket tilbage
- Norwalk Hospital
-
Stamford, Connecticut, Forenede Stater, 06902
- Rekruttering
- Stamford Hospital
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forenede Stater, 20007
- Rekruttering
- MedStar Georgetown University Hospital
-
Washington D.C., District of Columbia, Forenede Stater, 20010
- Rekruttering
- MedStar Washington Hospital Center
-
-
Florida
-
Clearwater, Florida, Forenede Stater, 00337
- Trukket tilbage
- Morton Plant Hospital - Bay Care
-
Gainesville, Florida, Forenede Stater, 32610
- Trukket tilbage
- University of Florida
-
Jacksonville, Florida, Forenede Stater, 32256
- Rekruttering
- Cancer Specialists of North Florida
-
Jacksonville, Florida, Forenede Stater, 32224
- Rekruttering
- Mayo Clinic Florida
-
Jupiter, Florida, Forenede Stater, 33458
- Rekruttering
- Jupiter Medical Center
-
Miami Beach, Florida, Forenede Stater, 33140
- Rekruttering
- Mount Sinai Comprehensive Cancer Center
-
Orange City, Florida, Forenede Stater, 32763
- Trukket tilbage
- Midland Florida Clinical Research Center, L
-
Orlando, Florida, Forenede Stater, 32806
- Aktiv, ikke rekrutterende
- Orlando Health
-
Palm Bay, Florida, Forenede Stater, 32909
- Rekruttering
- Cancer Care Centers of Brevard, Inc
-
Pembroke Pines, Florida, Forenede Stater, 33028
- Rekruttering
- Memorial Healthcare System
-
Pensacola, Florida, Forenede Stater, 32504
- Trukket tilbage
- Sacred Heart Medical Oncology Group
-
Plantation, Florida, Forenede Stater, 33324
- Rekruttering
- Sylvester Comprehensive Cancer Center
-
Stuart, Florida, Forenede Stater, 34994
- Trukket tilbage
- Cleveland Clinic Florida, Martin North Hospital
-
Tampa, Florida, Forenede Stater, 33614
- Trukket tilbage
- St. Joseph's Hospital
-
Weston, Florida, Forenede Stater, 33331
- Trukket tilbage
- Weston Hospital
-
-
Georgia
-
Athens, Georgia, Forenede Stater, 30607
- Rekruttering
- University Cancer & Blood Center, LLC.
-
Atlanta, Georgia, Forenede Stater, 30342
- Rekruttering
- Northside Hospital
-
Atlanta, Georgia, Forenede Stater, 30318
- Rekruttering
- Piedmont Cancer Institute
-
Marietta, Georgia, Forenede Stater, 30060
- Rekruttering
- Northwest Georgia Oncology Centers, PC
-
Newnan, Georgia, Forenede Stater, 30265
- Rekruttering
- Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta
-
Valdosta, Georgia, Forenede Stater, 31602
- Rekruttering
- Pearlman Cancer Center
-
-
Idaho
-
Boise, Idaho, Forenede Stater, 83712
- Trukket tilbage
- St Lukes Mountain States Tumor Institute
-
Coeur d'Alene, Idaho, Forenede Stater, 83814
- Rekruttering
- Kootenai Health
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60612
- Rekruttering
- Rush University Medical Center
-
Chicago, Illinois, Forenede Stater, 60611
- Rekruttering
- Northwestern Medicine
-
Chicago, Illinois, Forenede Stater, 60612
- Trukket tilbage
- University of Illinois
-
Chicago, Illinois, Forenede Stater, 60637
- Rekruttering
- University of Chicago Medical Center
-
Evanston, Illinois, Forenede Stater, 60201
- Rekruttering
- NorthShore University Healthsystem
-
Naperville, Illinois, Forenede Stater, 60540
- Rekruttering
- Edward Hospital
-
River Forest, Illinois, Forenede Stater, 60305
- Trukket tilbage
- West Suburban Medical Center- River Forest
-
Skokie, Illinois, Forenede Stater, 60076
- Trukket tilbage
- Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore
-
Springfield, Illinois, Forenede Stater, 62702
- Trukket tilbage
- Springfield Clinic LLP
-
Urbana, Illinois, Forenede Stater, 61801
- Rekruttering
- Carle Cancer Center
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46237
- Rekruttering
- Franciscan Health Indianapolis
-
Indianapolis, Indiana, Forenede Stater, 46260
- Trukket tilbage
- Investigative Clinical Research of Indiana, LLC
-
Lafayette, Indiana, Forenede Stater, 47904
- Trukket tilbage
- IU Health Arnett Hospital
-
Munster, Indiana, Forenede Stater, 46321
- Trukket tilbage
- Franciscan Health Munster
-
-
Iowa
-
Cedar Rapids, Iowa, Forenede Stater, 52403
- Trukket tilbage
- Mercy Medical Center
-
Des Moines, Iowa, Forenede Stater, 50309
- Rekruttering
- Mission Cancer & Blood - John Stoddard Cancer Center
-
Iowa City, Iowa, Forenede Stater, 52242
- Rekruttering
- University of Iowa Hospitals and Clinics
-
-
Kansas
-
Wichita, Kansas, Forenede Stater, 67214
- Rekruttering
- Cancer Center of Kansas
-
-
Kentucky
-
Lexington, Kentucky, Forenede Stater, 40536
- Trukket tilbage
- University of Kentucky
-
Louisville, Kentucky, Forenede Stater, 40207
- Rekruttering
- Norton Healthcare, Inc.
-
Paducah, Kentucky, Forenede Stater, 42003
- Rekruttering
- Mercy Health
-
-
Louisiana
-
Baton Rouge, Louisiana, Forenede Stater, 70809
- Rekruttering
- Mary Bird Perkins Cancer Center
-
New Orleans, Louisiana, Forenede Stater, 70112
- Trukket tilbage
- University Medical Center New Orleans
-
New Orleans, Louisiana, Forenede Stater, 70122
- Rekruttering
- University Medical Center - New Orleans
-
-
Maine
-
Scarborough, Maine, Forenede Stater, 04074
- Rekruttering
- New England Cancer Specialists
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21231
- Rekruttering
- Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
-
Baltimore, Maryland, Forenede Stater, 21215
- Rekruttering
- Sinai Hospital of Baltimore, Inc.
-
Baltimore, Maryland, Forenede Stater, 21229
- Rekruttering
- St. Agnes Hospital
-
Bethesda, Maryland, Forenede Stater, 20817
- Trukket tilbage
- American Oncology Partners of Maryland, PA
-
Frederick, Maryland, Forenede Stater, 21702
- Rekruttering
- James M Stockman Cancer Institute
-
Towson, Maryland, Forenede Stater, 21204
- Rekruttering
- Greater Baltimore Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Rekruttering
- Massachusetts General Hospital
-
Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Dana Farber Cancer Institute
-
Boston, Massachusetts, Forenede Stater, 02111
- Rekruttering
- Tufts Medical Center
-
Foxborough, Massachusetts, Forenede Stater, 02035
- Rekruttering
- Dana-Farber Cancer Institute @Foxborough
-
Methuen, Massachusetts, Forenede Stater, 01844
- Rekruttering
- Dana-Farber Cancer Institude at Merrimack Valley
-
Milford, Massachusetts, Forenede Stater, 01757
- Rekruttering
- Dana Farber Cancer Institute @ Milford Regional Hospital
-
South Weymouth, Massachusetts, Forenede Stater, 02190
- Rekruttering
- Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital
-
Springfield, Massachusetts, Forenede Stater, 01199
- Trukket tilbage
- Baystate Medical Center Inc.
-
Worcester, Massachusetts, Forenede Stater, 01655
- Trukket tilbage
- University of Massachusetts Worcester
-
-
Michigan
-
Detroit, Michigan, Forenede Stater, 48202
- Trukket tilbage
- Henry Ford Health System
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Rekruttering
- Cancer and Hematology Centers of Western Michigan
-
Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Trukket tilbage
- Ascension
-
Royal Oak, Michigan, Forenede Stater, 48073
- Rekruttering
- William Beaumont Hospital
-
Southfield, Michigan, Forenede Stater, 48075
- Trukket tilbage
- Ascension Providence Hospital Southfield Cancer Center
-
Ypsilanti, Michigan, Forenede Stater, 48197
- Trukket tilbage
- Trinity Health St. Joseph Mercy Ann Arbor
-
-
Minnesota
-
Maplewood, Minnesota, Forenede Stater, 55109
- Rekruttering
- Minnesota Oncology Hematology, PA
-
Minneapolis, Minnesota, Forenede Stater, 55455
- Rekruttering
- University of Minnesota Medical Center, Fairview
-
Minneapolis, Minnesota, Forenede Stater, 55407
- Rekruttering
- Virginia Piper Cancer Center (Allina Health)
-
Rochester, Minnesota, Forenede Stater, 55905
- Rekruttering
- Mayo Clinic Rochester
-
Saint Louis Park, Minnesota, Forenede Stater, 55426
- Rekruttering
- Metro Minnesota Community Oncology
-
-
Missouri
-
St Louis, Missouri, Forenede Stater, 63110
- Rekruttering
- Washington University School of Medicine
-
St Louis, Missouri, Forenede Stater, 63141
- Trukket tilbage
- Mercy Hospital
-
St Louis, Missouri, Forenede Stater, 63131
- Trukket tilbage
- Baptist Clinical Research Institute
-
-
Nebraska
-
Hastings, Nebraska, Forenede Stater, 68901
- Aktiv, ikke rekrutterende
- Mary Lanning Healthcare - Morrison Cancer Center
-
Omaha, Nebraska, Forenede Stater, 68114
- Rekruttering
- Oncology Hematology West - Methodist
-
Omaha, Nebraska, Forenede Stater, 68124
- Rekruttering
- Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89169
- Trukket tilbage
- Comprehensive Cancer Centers of Nevada
-
Reno, Nevada, Forenede Stater, 89511
- Trukket tilbage
- Cancer Care & Hematology Specialists
-
-
New Jersey
-
East Brunswick, New Jersey, Forenede Stater, 08816
- Rekruttering
- Regional Cancer Care Associates LLC
-
Flemington, New Jersey, Forenede Stater, 08822
- Rekruttering
- Hunterdon Medical Center
-
Florham Park, New Jersey, Forenede Stater, 07932
- Trukket tilbage
- Summit Medical Group, P.A.
-
New Brunswick, New Jersey, Forenede Stater, 08901
- Rekruttering
- Rutgers Health
-
Summit, New Jersey, Forenede Stater, 07901
- Rekruttering
- Overlook Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87131
- Rekruttering
- University of New Mexico
-
Farmington, New Mexico, Forenede Stater, 87401
- Rekruttering
- San Juan Oncology Associates
-
-
New York
-
Amsterdam, New York, Forenede Stater, 12010
- Trukket tilbage
- New York Oncology Hematology (NYOH)
-
Buffalo, New York, Forenede Stater, 14263
- Trukket tilbage
- Roswell Park Cancer Institute
-
East Syracuse, New York, Forenede Stater, 13057
- Rekruttering
- Hematology Oncology Associates of Central New York, PC
-
Lake Success, New York, Forenede Stater, 11042
- Rekruttering
- Northwell Health
-
New York, New York, Forenede Stater, 10016
- Rekruttering
- Laura and Isaac Perlmutter Cancer Canter
-
Rochester, New York, Forenede Stater, 14618
- Rekruttering
- Lipson Cancer Institute - Linden Oaks
-
Shirley, New York, Forenede Stater, 11967
- Rekruttering
- New York Cancer and Blood Specialists
-
Stony Brook, New York, Forenede Stater, 11794
- Rekruttering
- Stony Brook Medicine
-
Syracuse, New York, Forenede Stater, 13210
- Rekruttering
- SUNY Upstate Medical University
-
The Bronx, New York, Forenede Stater, 10467
- Trukket tilbage
- Montefiore Medical Center
-
Westbury, New York, Forenede Stater, 11590
- Trukket tilbage
- Clinical Research Alliance
-
White Plains, New York, Forenede Stater, 10601
- Rekruttering
- White Plains Hospital Physician Associates
-
-
North Carolina
-
Chapel Hill, North Carolina, Forenede Stater, 27514
- Rekruttering
- Lineberger Comprehensive Cancer Center
-
Charlotte, North Carolina, Forenede Stater, 28204
- Rekruttering
- Novant Health Cancer Institute - Elizabeth (Breast)
-
Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke Cancer Institute
-
Greensboro, North Carolina, Forenede Stater, 27403
- Rekruttering
- Cone Health Medical Group (Moses Cone Health System)
-
Greenville, North Carolina, Forenede Stater, 27834
- Trukket tilbage
- East Carolina University Health Medical Center
-
Pinehurst, North Carolina, Forenede Stater, 28374
- Trukket tilbage
- FirstHealth Outpatient Cancer Center
-
Raleigh, North Carolina, Forenede Stater, 27607
- Trukket tilbage
- UNC Rex Cancer Center
-
Rocky Mount, North Carolina, Forenede Stater, 27804
- Trukket tilbage
- UNC Nash Cancer Center
-
Winston-Salem, North Carolina, Forenede Stater, 27157
- Rekruttering
- Atrium Health Wake Forest Baptist
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45242
- Rekruttering
- Oncology Hematology Care, Inc.
-
Cincinnati, Ohio, Forenede Stater, 45220
- Rekruttering
- Good Samaritan Hospital
-
Columbus, Ohio, Forenede Stater, 43214
- Rekruttering
- Ohio Health Research Institute
-
Columbus, Ohio, Forenede Stater, 43221
- Rekruttering
- Anita Stewart Oncology Center
-
Columbus, Ohio, Forenede Stater, 43212
- Rekruttering
- Ohio State University CRS
-
Columbus, Ohio, Forenede Stater, 43215
- Trukket tilbage
- Columbus NCORP
-
Toledo, Ohio, Forenede Stater, 43623
- Trukket tilbage
- Toledo Clinic Cancer Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73104
- Trukket tilbage
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Bend, Oregon, Forenede Stater, 97701
- Rekruttering
- St. Charles Health System, Inc. DBA St. Charles Medical Center
-
Corvallis, Oregon, Forenede Stater, 97330
- Rekruttering
- Samaritan Hospital
-
Eugene, Oregon, Forenede Stater, 97401
- Rekruttering
- Willamette Valley Cancer Institute and Research Center
-
Medford, Oregon, Forenede Stater, 97504
- Trukket tilbage
- Asante Rogue Regional Medical Center
-
Portland, Oregon, Forenede Stater, 97239
- Rekruttering
- Oregon Health & Science University
-
Portland, Oregon, Forenede Stater, 97213
- Trukket tilbage
- Providence Cancer Institute - Oncology Clinical Trials
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, Forenede Stater, 18015
- Trukket tilbage
- Saint Luke's University Hospital
-
Lancaster, Pennsylvania, Forenede Stater, 17601
- Rekruttering
- Lancaster General Health
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- University of Pennsylvania Abramson Cancer Center
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Rekruttering
- UPMC Magee-Womens Hospital
-
Sayre, Pennsylvania, Forenede Stater, 18840
- Rekruttering
- Guthrie Clinical Research
-
West Reading, Pennsylvania, Forenede Stater, 19611
- Trukket tilbage
- Reading Hospital and Medical Center
-
Wynnewood, Pennsylvania, Forenede Stater, 19106
- Rekruttering
- Lankenau Medical Center
-
York, Pennsylvania, Forenede Stater, 17403
- Rekruttering
- Cancer Care Associates of York
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02905
- Rekruttering
- Providence Health
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Rekruttering
- Medical University of South Carolina
-
Greenville, South Carolina, Forenede Stater, 29607
- Rekruttering
- St. Francis Cancer Center
-
Spartanburg, South Carolina, Forenede Stater, 29303
- Rekruttering
- Spartanburg Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57701
- Rekruttering
- Monument Health Cancer Care Institute
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Rekruttering
- Avera Cancer Institute
-
-
Tennessee
-
Kingsport, Tennessee, Forenede Stater, 37660
- Trukket tilbage
- Ballad Health Cancer Care - Kingsport
-
Knoxville, Tennessee, Forenede Stater, 37920
- Rekruttering
- University of Tennessee
-
Knoxville, Tennessee, Forenede Stater, 37909
- Trukket tilbage
- Center for Biomedical Research, LLC
-
-
Texas
-
Abilene, Texas, Forenede Stater, 79601
- Trukket tilbage
- Hendrick Health System
-
Austin, Texas, Forenede Stater, 78731
- Rekruttering
- Texas Oncology
-
El Paso, Texas, Forenede Stater, 79902
- Rekruttering
- Texas Oncology
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- MD Anderson Cancer Center
-
Lubbock, Texas, Forenede Stater, 79410
- Trukket tilbage
- Joe Arrington Cancer Research and Treatment Center
-
San Antonio, Texas, Forenede Stater, 78240
- Rekruttering
- Texas Oncology
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84112
- Rekruttering
- Huntsman Cancer Institute
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908
- Rekruttering
- University of Virginia
-
Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Inova Fairfax Hospital
-
Midlothian, Virginia, Forenede Stater, 23114
- Rekruttering
- Bon Secours Cancer Institute at St. Francis
-
Richmond, Virginia, Forenede Stater, 23298
- Trukket tilbage
- Virginia Commonwealth University Medical Center
-
Wytheville, Virginia, Forenede Stater, 24382
- Rekruttering
- Oncology and Hematology Associates of Southwest Virginia, Inc
-
-
Washington
-
Lacey, Washington, Forenede Stater, 98503
- Rekruttering
- Providence Regional Cancer System
-
Puyallup, Washington, Forenede Stater, 98372
- Rekruttering
- MultiCare Regional Cancer Center - Tacoma
-
Puyallup, Washington, Forenede Stater, 98373
- Rekruttering
- Northwest Medical Specialties, PLLC
-
Renton, Washington, Forenede Stater, 98055
- Trukket tilbage
- University of Washington
-
Spokane, Washington, Forenede Stater, 99208
- Trukket tilbage
- Medical Oncology Associates
-
-
West Virginia
-
Morgantown, West Virginia, Forenede Stater, 26505
- Rekruttering
- West Virginia University Hospital
-
-
Wisconsin
-
Appleton, Wisconsin, Forenede Stater, 54911
- Trukket tilbage
- ThedaCare Regional Cancer Center
-
Franklin, Wisconsin, Forenede Stater, 53132
- Rekruttering
- Ascension St. Francis Reiman Cancer Center
-
Green Bay, Wisconsin, Forenede Stater, 54303
- Trukket tilbage
- HSHS Saint Mary's Hospital Medical Center - Green Bay
-
Madison, Wisconsin, Forenede Stater, 53792
- Trukket tilbage
- University of Wisconsin
-
-
-
-
-
Amiens, Frankrig, 80000
- Rekruttering
- CHU Amiens Picardie
-
Chambray-lès-Tours, Frankrig, 37170
- Rekruttering
- Pôle Santé Léonard De Vinci - ROC37
-
Dijon, Frankrig, 21000
- Rekruttering
- Institut de Cancerologie de Bourgogne
-
Le Mans, Frankrig, 72000
- Rekruttering
- Clinique Victor Hugo
-
Limoges, Frankrig, 87042
- Rekruttering
- chu de Limoges
-
Loire Atlantique, Frankrig, 44 805
- Rekruttering
- Institut de Cancérologie de l'Ouest (ICO) - St Herblain
-
Lyon, Frankrig, 69008
- Rekruttering
- Hôpital Privé Jean Mermoz
-
Nancy, Frankrig, 54000
- Rekruttering
- Centre D'Oncologie de Gentilly
-
Nantes, Frankrig, 44277
- Rekruttering
- L'Hôpital Privé du Confluent
-
Nîmes, Frankrig, 30029
- Rekruttering
- CHU de Nimes
-
Plérin, Frankrig, 22190
- Rekruttering
- Hopital Privé des Côtes d'Armor - Centre CARIO-HPCA
-
Poitiers, Frankrig, 86021
- Rekruttering
- CHU de Poitiers, 2 Rue de la Milétrie
-
Rennes, Frankrig, 35042
- Rekruttering
- Centre Eugène Marquis
-
Strasbourg, Frankrig, 67000
- Aktiv, ikke rekrutterende
- Clinique Ste Anne Strasbourg_Oncologie Liberale
-
Toulouse, Frankrig, 31059
- Rekruttering
- Oncopole Claudius Regaud - IUCT-O
-
Villejuif, Frankrig, 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
- Ikke rekrutterer endnu
- University Hospital Limerick
-
Wilton, Irland, T12 DC4A
- Rekruttering
- Cork University Hospital
-
-
-
-
-
Bari, Italien, 70124
- Rekruttering
- IRCCS Istituto Tumori "Giovanni Paolo II"
-
Bologna, Italien, 40138
- Rekruttering
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
-
Florence, Italien, 50134
- Rekruttering
- Azienda Ospedaliera Universitaria Careggi
-
Genova, Italien, 16132
- Rekruttering
- IRCCS AOM Ospedale Policlinico San Martino
-
Meldola, Italien, 47014
- Rekruttering
- Istituto Romagnolo Per Lo Studio Dei Tumori (IRST) 'Dino Amadori? IRCCS
-
Milan, Italien, 20133
- Rekruttering
- Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano
-
Misterbianco, Italien, 95125
- Rekruttering
- Humanitas Istituto Clinico Catanese
-
Modena, Italien, 41125
- Rekruttering
- AOU Modena
-
Naples, Italien, 80131
- Rekruttering
- IRCCS Fondazione G. Pascale
-
Naples, Italien, 80131
- Aktiv, ikke rekrutterende
- AOU Federico II
-
Roma, Italien, 168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
-
Rome, Italien, 00128
- Rekruttering
- Fondazione Policlinico Universitario Campus Bio-Medico di Roma
-
Rozzano, Italien, 20089
- Aktiv, ikke rekrutterende
- ASST Papa Giovanni XXIII
-
Torino, Italien, 10123
- Rekruttering
- AOU Città della Salute e della Scienza di Torino
-
Trento, Italien, 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, Spanien, 15006
- Rekruttering
- Medical Oncology Unit. A Coruña University Hospital
-
Badalona, Spanien, 08916
- Rekruttering
- ICO Badalona - Hospital Germans Trias I Pujol
-
Barakaldo, Spanien, 48903
- Rekruttering
- Hospital Universitary of Cruces
-
Barcelona, Spanien, 08036
- Rekruttering
- Hospital Clinic de Barcelona
-
Barcelona, Spanien, 8041
- Rekruttering
- Hospital de la Santa Creu i Sant Pau
-
Barcelona, Spanien, 8003
- Rekruttering
- Hospital del Mar
-
Castellon, Spanien, 12002
- Rekruttering
- Consorcio Hospitalario Provincial de Castellón
-
Cáceres, Spanien, 10003
- Rekruttering
- Hospital Universitario San Pedro de Alcántara
-
Córdoba, Spanien, 14004
- Rekruttering
- Hospital Reina Sofia
-
Donostia / San Sebastian, Spanien, 20014
- Rekruttering
- Hospital Donostia
-
Elche, Spanien, 03203
- Rekruttering
- Hospital General Universitario De Elche
-
Fuenlabrada, Spanien, 28942
- Rekruttering
- Hospital Universitario de Fuenlabrada
-
Galdakao, Spanien, 48960
- Rekruttering
- Hospital Galdakao
-
Granada, Spanien, 18014
- Rekruttering
- Hospital Universitario Virgen de las Nieves
-
Granada, Spanien, 18016
- Rekruttering
- Hospital Universitario Clínico San Cecilio
-
Jaén, Spanien, 23007
- Rekruttering
- Hospital Universitario de Jaen
-
León, Spanien, 24008
- Rekruttering
- H. León
-
Lleida, Spanien, 25198
- Rekruttering
- Hospital Arnau de Vilanova
-
Madrid, Spanien, 28007
- Rekruttering
- Hospital General Universitario Gregorio Maranon
-
Madrid, Spanien, 28007
- Rekruttering
- Hospital Beata María Ana
-
Manresa, Spanien, 08242
- Rekruttering
- Althaia Xarxa Assistencial de Manresa
-
Murcia, Spanien, 30008
- Rekruttering
- Hospital General Univers
-
Murcia, Spanien, 30008
- Trukket tilbage
- Hospital Universitario Morales Meseguer
-
Málaga, Spanien, 29010
- Rekruttering
- Hospital Universitario Virgen de la Victoria
-
Málaga, Spanien, 29011
- Rekruttering
- Hosp. Mat-Inf. Carlos Haya
-
Pamplona, Spanien, 31008
- Rekruttering
- Clínica Universidad de Navarra - Madrid
-
Reus, Spanien, 43204
- Rekruttering
- Hospital Universitari Sant Joan de Reus
-
Sabadell, Spanien, 08028
- Rekruttering
- Hospital Parc Tauli
-
San Cristóbal de La Laguna, Spanien, 38320
- Rekruttering
- Hospital Universitario de Canarias
-
Santander, Spanien, 39008
- Rekruttering
- HU Marqués de Valdecilla
-
Seville, Spanien, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena
-
Seville, Spanien, 41010
- Rekruttering
- Hospital Quironsalud Sagrado Corazón
-
Toledo, Spanien, 45007
- Rekruttering
- Hospital de Toledo
-
Valencia, Spanien, 46010
- Rekruttering
- Hospital Clínico Universitario de Valencia
-
Valencia, Spanien, 46014
- Rekruttering
- Hospital Clínico Universitario de Valencia
-
Valladolid, Spanien, 47003
- Rekruttering
- Hospital Clinico Universitario de Valladolid
-
Zaragoza, Spanien, 50009
- Rekruttering
- Isabel la Catolica nº 1-3
-
-
-
-
-
Chungcheongnam-do, Sydkorea, 31151
- Rekruttering
- Soonchunhyang University Cheonan Hospital
-
Daegu, Sydkorea, 41404
- Rekruttering
- Kyungpook National University Chilgok Hospital
-
Gyeonggi-do, Sydkorea, 13620
- Rekruttering
- Seoul National University Bundang Hospital
-
Seodaemun-gu, Sydkorea, 3722
- Rekruttering
- Severance Hospital
-
Seoul, Sydkorea, 05505
- Rekruttering
- Asan Medical Center
-
Seoul, Sydkorea, 02841
- Rekruttering
- Korea University Anam Hospital
-
Seoul, Sydkorea, 6351
- Rekruttering
- Samsung Medical Center
-
Seoul, Sydkorea
- Rekruttering
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Seoul, Sydkorea, 06273
- Rekruttering
- Gangnam Severance Hospital
-
Seoul, Sydkorea, 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
- Trukket tilbage
- 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
- Trukket tilbage
- 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
- Ikke rekrutterer endnu
- Marienplatz 2
-
Worms, Tyskland, 67550
- Rekruttering
- Klinikum Worms Frauenklinik
-
Wuppertal, Tyskland, 42283
- Rekruttering
- Helios University Hospital University Witten/Herdecke
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 navne:
Administered intravenously
Andre navne:
|
|
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 navne:
Tablets administered orally
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procentdel af deltagere, der oplever behandlingsfremkomne bivirkninger (TEAE'er)
Tidsramme: Første dosisdato op til 38 måneder plus 30 dage
|
Første dosisdato op til 38 måneder plus 30 dage
|
|
|
Procentdel af deltagere, der oplever laboratorieabnormiteter
Tidsramme: Første dosisdato op til 38 måneder plus 30 dage
|
Første dosisdato op til 38 måneder plus 30 dage
|
|
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Gilead Study Director, Gilead Sciences
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. december 2022
Primær færdiggørelse (Anslået)
1. juni 2027
Studieafslutning (Anslået)
1. august 2031
Datoer for studieregistrering
Først indsendt
21. november 2022
Først indsendt, der opfyldte QC-kriterier
21. november 2022
Først opslået (Faktiske)
1. december 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Hudsygdomme
- Brystsygdomme
- Brystneoplasmer
- Hud- og bindevævssygdomme
- Tredobbelt negative brystneoplasmer
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Nukleinsyrer, nukleotider og nukleosider
- Deoxycytidin
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Nukleosider
- Uracil
- Pyrimidinoner
- Deoxyribonucleosider
- Fluorouracil
- Capecitabin
- pembrolizumab
- Sacituzumab Govitecan
Andre undersøgelses-id-numre
- GS-US-595-6184
- 2024-512279-10 (Anden identifikator: European Medicines Agency)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .