Sacituzumab Tirumotecan (MK-2870) Pluss Pembrolizumab versus TPC i TNBC som ikke oppnådde pCR
3. november 2026 oppdatert av: Merck Sharp & Dohme LLC
En fase 3, randomisert, åpen studie for å sammenligne effektiviteten og sikkerheten til adjuvans MK-2870 i kombinasjon med Pembrolizumab (MK-3475) versus behandling av leges valg (TPC) hos deltakere med trippel-negativ brystkreft (TNBC) Som mottok neoadjuvant terapi og ikke oppnådde en patologisk fullstendig respons (pCR) ved kirurgi
This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
1530
Fase
- Fase 3
Kontakter og plasseringer
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Studiesteder
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Buenos Aires, Argentina, C1187AAN
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- Sanatorio Finochietto ( Site 0513)
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Buenos Aires, Argentina, C1431FWO
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Buenos Aires
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Capital Federal, Buenos Aires, Argentina, C1118AAT
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., Argentina, C1426ANZ
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DSV
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New South Wales
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Macquarie University, New South Wales, Australia, 2109
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- Macquarie University-MQ Health Clinical Trials Unit ( Site 2703)
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Westmead, New South Wales, Australia, 2145
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Queensland
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Brisbane, Queensland, Australia, 4029
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Victoria
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Frankston, Victoria, Australia, 3199
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Namur, Belgia, 5530
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Bruxelles-Capitale, Region de
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Brussels, Bruxelles-Capitale, Region de, Belgia, 1200
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- Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0901)
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgia, 9000
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São Paulo, Brasil, 04014-002
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Ceará
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Fortaleza, Ceará, Brasil, 60810-180
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Espírito Santo
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Vitória, Espírito Santo, Brasil, 29043-260
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- Hospital Santa Rita de Cassia ( Site 0617)
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Piauí
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Teresina, Piauí, Brasil, 64049-200
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- Oncoclínica Oncologistas Associados-Clinical Research ( Site 0607)
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90110-270
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Santa Cruz do Sul, Rio Grande do Sul, Brasil, 96830-180
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Santa Catarina
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Lages, Santa Catarina, Brasil, 88501-001
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- ANIMI - Unidade de Tratamento Oncologico ( Site 0616)
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São Paulo
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Taubaté, São Paulo, Brasil, 12030-200
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- Instituto do Câncer Brasil - Unidade Taubaté ( Site 0608)
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
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- Arthur J.E. Child Comprehensive Cancer Centre ( Site 0421)
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Edmonton, Alberta, Canada, T6G 1Z2
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
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Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 6Z8
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
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Kingston, Ontario, Canada, K7L 2V7
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Newmarket, Ontario, Canada, L3Y 2P9
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M2K 1E1
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Toronto, Ontario, Canada, M5G 2M9
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H3T 1E2
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Montreal, Quebec, Canada, H1T 2M4
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- CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0419)
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Montreal, Quebec, Canada, H2X 3E4
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Rimouski, Quebec, Canada, G5L 5T1
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Trois-Rivières, Quebec, Canada, G8Z 3R9
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Antioquia
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Rionegro, Antioquia, Colombia, 054040
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- Clinica Somer ( Site 3704)
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 110131
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- FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 3700)
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Bogotá, Bogota D.C., Colombia, 111511
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- Instituto Nacional De Cancerologia ( Site 3701)
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Cesar Department
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Valledupar, Cesar Department, Colombia, 200001
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Capital Region
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Herlev, Capital Region, Danmark, 2730
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Central Jutland
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Aarhus N, Central Jutland, Danmark, 8200
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North Denmark
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Aalborg, North Denmark, Danmark, 9000
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Region Syddanmark
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Odense C, Region Syddanmark, Danmark, 5000
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Sønderborg, Region Syddanmark, Danmark, 6400
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Vejle, Region Syddanmark, Danmark, 7100
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Northern Savonia
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Kuopio, Northern Savonia, Finland, 70210
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Pirkanmaa
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Tampere, Pirkanmaa, Finland, 33520
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Southwest Finland
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Turku, Southwest Finland, Finland, 20520
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Uusimaa
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Helsinki, Uusimaa, Finland, 00029
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Alabama
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Mobile, Alabama, Forente stater, 36607
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- Infirmary Cancer Care ( Site 0001)
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Arizona
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Chandler, Arizona, Forente stater, 85224
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California
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Fountain Valley, California, Forente stater, 92708
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La Jolla, California, Forente stater, 92037
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Los Alamitos, California, Forente stater, 90720
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Oakland, California, Forente stater, 94611
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Oceanside, California, Forente stater, 92056
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Roseville, California, Forente stater, 95661
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- Kaiser Permanente - Roseville ( Site 0081)
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San Francisco, California, Forente stater, 94115
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- Kaiser Permanente - San Francisco ( Site 0080)
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Santa Clara, California, Forente stater, 95051
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- Kaiser Permanente - Santa Clara ( Site 0082)
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Santa Rosa, California, Forente stater, 95403
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- Providence Medical Foundation ( Site 9543)
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Vallejo, California, Forente stater, 94589
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- Kaiser Permanente Vallejo Medical Center ( Site 0060)
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Walnut Creek, California, Forente stater, 94596
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- Kaiser Permanente - Walnut Creek ( Site 0078)
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Walnut Creek, California, Forente stater, 94598
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- Bass Medical Group ( Site 0089)
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Colorado
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Grand Junction, Colorado, Forente stater, 81501
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- Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046)
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Connecticut
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Farmington, Connecticut, Forente stater, 06030
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New Haven, Connecticut, Forente stater, 06510
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Delaware
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Newark, Delaware, Forente stater, 19713
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- Helen F. Graham Cancer Center & Research Institute ( Site 0018)
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- Telefonnummer: 302-366-1200
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Florida
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Altamonte Springs, Florida, Forente stater, 32701
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Orlando, Florida, Forente stater, 32806
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- Telefonnummer: 321-843-8370
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St. Petersburg, Florida, Forente stater, 33709
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- Comprehensive Hematology Oncology ( Site 0091)
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Stuart, Florida, Forente stater, 34994
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- Cleveland Clinic Martin North Hospital ( Site 0114)
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- Telefonnummer: 772-419-2146
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Georgia
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Thomasville, Georgia, Forente stater, 31792
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- Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040)
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Illinois
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Arlington Heights, Illinois, Forente stater, 60005
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- Illinois Cancer Specialists (ICS) ( Site 8010)
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Carterville, Illinois, Forente stater, 62918
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Skokie, Illinois, Forente stater, 60077
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- Orchard Healthcare Research Inc. ( Site 0014)
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Ta kontakt med:
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- Telefonnummer: 224-534-7580
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Indiana
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Dyer, Indiana, Forente stater, 46311
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- Northwest Cancer Center - Dyer Clinic ( Site 0097)
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Fort Wayne, Indiana, Forente stater, 46845
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- Parkview Research Center at Parkview Regional Medical Center ( Site 0011)
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- Telefonnummer: 260-266-6313
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Kansas
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Wichita, Kansas, Forente stater, 67214
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- Cancer Center of Kansas ( Site 0004)
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Kentucky
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Edgewood, Kentucky, Forente stater, 41017
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- Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0044)
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- Telefonnummer: 859-301-4000
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Louisiana
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Alexandria, Louisiana, Forente stater, 71301
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- CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0109)
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- Telefonnummer: 318-528-6976
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Monroe, Louisiana, Forente stater, 71202
- Fullført
- Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063)
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Shreveport, Louisiana, Forente stater, 71103
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- Louisiana State University Health Sciences Shreveport ( Site 0029)
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- Study Coordinator
- Telefonnummer: 318-813-1429
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Maryland
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Silver Spring, Maryland, Forente stater, 20910
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- Holy Cross Hospital ( Site 0069)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 301-754-7552
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- Rekruttering
- University of Michigan ( Site 0103)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 800-865-1125
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Detroit, Michigan, Forente stater, 48202
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- Henry Ford Health ( Site 0010)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 313-598-2556
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Royal Oak, Michigan, Forente stater, 48073
- Fullført
- Profound Research LLC ( Site 0074)
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Minnesota
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Saint Louis Park, Minnesota, Forente stater, 55426
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- Metro-Minnesota Community Clinical Oncology ( Site 0031)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 952-993-3252
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Mississippi
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Jackson, Mississippi, Forente stater, 39216
- Rekruttering
- University of Mississippi Medical Center ( Site 0043)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 601-984-5590
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Missouri
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Fenton, Missouri, Forente stater, 63026
- Fullført
- SSM Health Cancer Care - Fenton ( Site 0088)
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Osage Beach, Missouri, Forente stater, 65065
- Rekruttering
- Lake Regional Hospital ( Site 0009)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 573-302-2772
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St Louis, Missouri, Forente stater, 63108
- Rekruttering
- Siteman Cancer Center ( Site 0099)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 314-362-0263
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Nevada
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Las Vegas, Nevada, Forente stater, 89102
- Rekruttering
- Optum Care Cancer Center ( Site 9535)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 702-724-8787
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Las Vegas, Nevada, Forente stater, 89128
- Rekruttering
- Comprehensive Cancer Centers of Nevada - Peak ( Site 0047)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 702-609-9427
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87109
- Rekruttering
- New Mexico Oncology Hematology Consultants Ltd. ( Site 0090)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 505-842-8171
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Santa Fe, New Mexico, Forente stater, 87505
- Rekruttering
- CHRISTUS St. Vincent Regional Cancer Center ( Site 0118)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 505-913-8953
-
-
New York
-
New York, New York, Forente stater, 10029
- Rekruttering
- Icahn School of Medicine at Mount Sinai ( Site 0123)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 212-241-3300
-
New York, New York, Forente stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center ( Site 0067)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 212-639-2000
-
New York, New York, Forente stater, 10011
- Rekruttering
- The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0135)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 212-604-6000
-
Westbury, New York, Forente stater, 11590
- Rekruttering
- Clinical Research Alliance ( Site 0086)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 516-734-8906
-
-
North Carolina
-
Charlotte, North Carolina, Forente stater, 28204
- Rekruttering
- Levine Cancer Institute ( Site 0083)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 980-442-3130
-
Fayetteville, North Carolina, Forente stater, 28304
- Rekruttering
- Cape Fear Valley Health System ( Site 0136)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 472-210-8847
-
-
North Dakota
-
Bismarck, North Dakota, Forente stater, 58501
- Rekruttering
- Sanford Cancer Center Bismarck ( Site 0058)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 701-323-5741
-
Fargo, North Dakota, Forente stater, 58102
- Rekruttering
- Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0056)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 701-234-2000
-
Grand Forks, North Dakota, Forente stater, 58201
- Rekruttering
- Altru Cancer Center ( Site 0104)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 701-780-5451
-
-
Ohio
-
Canton, Ohio, Forente stater, 44708
- Rekruttering
- Cleveland Clinic - Mercy Hospital ( Site 0057)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 330-489-1274
-
Massillon, Ohio, Forente stater, 44646
- Rekruttering
- Tri-County Hematology & Oncology Associates, Inc. ( Site 0076)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 330-478-0001
-
Maumee, Ohio, Forente stater, 43537
- Rekruttering
- Taylor Cancer Research Center ( Site 9500)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 567-402-4501
-
Zanesville, Ohio, Forente stater, 43701
- Rekruttering
- Genesis Healthcare System ( Site 0025)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 740-454-5271
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater, 73102
- Fullført
- Hightower Clinical, LLC ( Site 0085)
-
Tulsa, Oklahoma, Forente stater, 74146
- Rekruttering
- Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 918-505-3200
-
-
Oregon
-
Portland, Oregon, Forente stater, 97213
- Rekruttering
- Providence Portland Medical Center ( Site 0116)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 503-215-1979
-
Portland, Oregon, Forente stater, 97225
- Rekruttering
- Providence Oncology and Hematology Care Clinic - Westside ( Site 0126)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 503-215-1979
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19107
- Rekruttering
- Sidney Kimmel Cancer Center at Jefferson ( Site 0049)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 215-955-8874
-
York, Pennsylvania, Forente stater, 17403
- Rekruttering
- Cancer Care Associates Of York ( Site 9517)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 717-741-9229
-
-
South Dakota
-
Sioux Falls, South Dakota, Forente stater, 57104
- Rekruttering
- Sanford Cancer Center ( Site 0059)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 605-328-8000
-
-
Tennessee
-
Germantown, Tennessee, Forente stater, 38138
- Rekruttering
- West Cancer Center and Research Institute ( Site 0084)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 901-683-0055
-
Memphis, Tennessee, Forente stater, 38120
- Rekruttering
- Baptist Cancer Center ( Site 0101)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 901-226-3077
-
Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- SCRI Oncology Partners ( Site 7000)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 615-329-7274
-
Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- One Oncology - Tennessee Oncology ( Site 0098)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 615-986-4350
-
Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Tennessee Oncology ( Site 0111)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 615-986-4350
-
Nashville, Tennessee, Forente stater, 37212
- Rekruttering
- Vanderbilt Health One Hundred Oaks ( Site 0042)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 800-811-8480
-
Nashville, Tennessee, Forente stater, 37208
- Fullført
- Nashville General Hospital ( Site 0072)
-
-
Texas
-
Abilene, Texas, Forente stater, 79601
- Rekruttering
- Hendrick Medical Center ( Site 0117)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 325-670-2000
-
Amarillo, Texas, Forente stater, 79106
- Rekruttering
- Harrington Cancer Center ( Site 0061)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 806-359-4673
-
Dallas, Texas, Forente stater, 75246
- Rekruttering
- Texas Oncology - DFW ( Site 8000)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 214-370-1000
-
Dallas, Texas, Forente stater, 75390
- Rekruttering
- Parkland Health & Hospital System ( Site 0096)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 214-645-4673
-
Dallas, Texas, Forente stater, 75390
- Rekruttering
- University of Texas Southwestern Medical Center ( Site 0032)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 214-645-4673
-
Flower Mound, Texas, Forente stater, 75028
- Rekruttering
- Texas Oncology - Northeast Texas ( Site 8005)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 972-537-4100
-
Fort Worth, Texas, Forente stater, 76104
- Rekruttering
- John Peter Smith Hospital ( Site 0106)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 817-702-8049
-
Houston, Texas, Forente stater, 77030
- Rekruttering
- Oncology Consultants P.A. ( Site 0107)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 713-600-0900
-
Laredo, Texas, Forente stater, 78041
- Rekruttering
- Laguna Clinical Research Associates LLC ( Site 0068)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 956-724-8543
-
San Antonio, Texas, Forente stater, 78229
- Rekruttering
- Mays Cancer Center ( Site 0122)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 210-450-1000
-
Tyler, Texas, Forente stater, 75701
- Rekruttering
- The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0055)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 903-592-6152
-
Webster, Texas, Forente stater, 77598
- Rekruttering
- Texas Oncology - Gulf Coast ( Site 8009)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 281-332-7505
-
-
Utah
-
Murray, Utah, Forente stater, 84107
- Rekruttering
- Intermountain Medical Center ( Site 0113)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 801-507-3630
-
-
Virginia
-
Fredericksburg, Virginia, Forente stater, 22408
- Rekruttering
- Hematology Oncology Associates of Fredericksburg ( Site 9550)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 540-371-0079
-
Fredericksburg, Virginia, Forente stater, 22405
- Rekruttering
- Mary Washington Hospital ( Site 0129)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 540-300-6182
-
Midlothian, Virginia, Forente stater, 23114
- Rekruttering
- Bon Secours Memorial Regional Medical Center-Oncology Research Department ( Site 0020)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 804-893-8717
-
Norfolk, Virginia, Forente stater, 23502
- Rekruttering
- Virginia Oncology Associates (VOA) ( Site 8008)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 646-694-8125
-
Richmond, Virginia, Forente stater, 23229
- Rekruttering
- Virginia Cancer Institute ( Site 0034)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 804-287-3000
-
-
Washington
-
Tacoma, Washington, Forente stater, 98405
- Rekruttering
- Northwest Medical Specialties, PLLC ( Site 0093)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 253-428-8700
-
-
Wisconsin
-
Madison, Wisconsin, Forente stater, 53715
- Rekruttering
- SSM Health Dean Medical Group ( Site 0087)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 516-488-2918
-
-
-
-
-
Paris, Frankrike, 75020
- Rekruttering
- Hôpital Tenon ( Site 1303)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33156017825
-
-
Alpes-Maritimes
-
Nice, Alpes-Maritimes, Frankrike, 06189
- Rekruttering
- Centre Antoine-Lacassagne ( Site 1308)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33492031000
-
-
Aquitaine
-
Bayonne, Aquitaine, Frankrike, 64109
- Rekruttering
- Centre Hospitalier de la Cote Basque ( Site 1315)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33559443762
-
-
Ardeche
-
Guilherand-Granges, Ardeche, Frankrike, 07500
- Rekruttering
- Hôpital Privé Drôme-Ardèche ( Site 1301)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33475756604
-
-
Auvergne
-
Clermont-Ferrand, Auvergne, Frankrike, 63011
- Rekruttering
- Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1307)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0473278005
-
-
Auvergne-Rhône-Alpes
-
Lyon Cedex08, Auvergne-Rhône-Alpes, Frankrike, 69373
- Rekruttering
- CENTRE LEON BERARD ( Site 1300)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33478782644
-
-
Bouches-du-Rhone
-
Marseille, Bouches-du-Rhone, Frankrike, 13009
- Rekruttering
- Institut Paoli-Calmettes ( Site 1309)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33491223611
-
-
Calvados
-
Caen, Calvados, Frankrike, 14076
- Rekruttering
- Centre François Baclesse ( Site 1318)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33231455050
-
-
Cote-d Or
-
Dijon, Cote-d Or, Frankrike, 21079
- Rekruttering
- Centre Georges François Leclerc ( Site 1312)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 03 70 63 24 03
-
-
Doubs
-
Besançon, Doubs, Frankrike, 25000
- Fullført
- CHU Besançon ( Site 1311)
-
-
Finistere
-
Brest, Finistere, Frankrike, 29200
- Rekruttering
- CHRU Brest - Hopital Cavale Blanche ( Site 1304)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33230338161
-
-
Gironde
-
Bordeaux, Gironde, Frankrike, 33000
- Rekruttering
- Clinique Tivoli Ducos ( Site 1322)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33556116296
-
-
Hauts-de-Seine
-
Levallois-Perret, Hauts-de-Seine, Frankrike, 92300
- Rekruttering
- Hôpital Franco-Britannique - Fondation Cognacq-Jay ( Site 1321)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33147591915
-
-
Loire-Atlantique
-
Saint-Herblain, Loire-Atlantique, Frankrike, 44805
- Rekruttering
- Institut de Cancérologie de l'Ouest ( Site 1305)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33240679900
-
-
Maine-et-Loire
-
Angers, Maine-et-Loire, Frankrike, 49055
- Rekruttering
- Institut de Cancérologie de l'Ouest ( Site 1316)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 02 41 35 27 00
-
-
Nord
-
Valenciennes, Nord, Frankrike, 59300
- Rekruttering
- Centre de Cancerologie Les Dentellieres ( Site 1306)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33327091010
-
-
Pyrenees-Atlantiques
-
Pau, Pyrenees-Atlantiques, Frankrike, 64046
- Rekruttering
- Centre Hospitalier de Pau ( Site 1302)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33559726996
-
-
Seine-Maritime
-
Rouen, Seine-Maritime, Frankrike, 76038
- Rekruttering
- Centre Henri Becquerel ( Site 1319)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 02 32 08 22 22
-
-
-
-
-
Thessaloniki, Hellas, 570 01
- Rekruttering
- European Interbalkan Medical Center ( Site 1502)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302313252011
-
Thessaloniki, Hellas, 570 01
- Rekruttering
- European Interbalkan Medical Center ( Site 1507)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302310390671
-
-
Achaia
-
Pátrai, Achaia, Hellas, 26504
- Rekruttering
- UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1509)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302610999791
-
-
Attica
-
Athens, Attica, Hellas, 115 26
- Rekruttering
- Errikos Dunant Hospital Center-1st Medical Oncology Dept. ( Site 1508)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302106972433
-
Athens, Attica, Hellas, 115 28
- Rekruttering
- Aretaieio Hospital Oncology Unit ( Site 1505)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302107286444
-
-
Thessaly
-
Larissa, Thessaly, Hellas, 411 10
- Rekruttering
- University General Hospital of Larissa ( Site 1503)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302413502785
-
-
-
-
-
Hong Kong, Hong Kong
- Rekruttering
- Queen Mary Hospital ( Site 3600)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +852 2255 3838
-
Kowloon, Hong Kong
- Rekruttering
- Hong Kong United Oncology Centre ( Site 3601)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +852 2386 8002
-
Shatin, Hong Kong, 000000
- Rekruttering
- Prince of Wales Hospital ( Site 3602)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: + 852 3505 2211
-
-
-
-
-
Cork, Irland, T12 DV56
- Rekruttering
- Bon Secours Cork Hospital ( Site 1600)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +353214542807
-
Dublin, Irland, D04 T6F4
- Rekruttering
- St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1601)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +353 1 221 4982
-
Galway, Irland, Galway
- Rekruttering
- University College Hospital - Galway ( Site 1602)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +35391524222
-
-
-
-
-
Beersheba, Israel, 8410101
- Rekruttering
- Soroka Medical Center-Oncology ( Site 1704)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0507425629
-
Jerusalem, Israel, 9112001
- Rekruttering
- Hadassah Medical Center ( Site 1700)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +972-2-6778510
-
Jerusalem, Israel, 9103102
- Rekruttering
- Shaare Zedek Medical Center ( Site 1706)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +97226555999
-
Petah Tikva, Israel, 4941492
- Rekruttering
- Rabin Medical Center ( Site 1702)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +972-3-9378076
-
Ramat Gan, Israel, 5265601
- Rekruttering
- Sheba Medical Center-ONCOLOGY ( Site 1701)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +972-35304436
-
Tel Aviv, Israel, 6423906
- Rekruttering
- Sourasky Medical Center ( Site 1705)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +972-3-6947557
-
-
-
-
-
Bologna, Italia, 40138
- Rekruttering
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1810)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +39 0512144548
-
Milan, Italia, 20132
- Rekruttering
- Ospedale San Raffaele-Oncologia Medica ( Site 1814)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390226436530
-
Novara, Italia, 28100
- Rekruttering
- Azienda Ospedaliero Universitaria Maggiore della Carità-SCDU ONCOLOGIA ( Site 1804)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +3903213733822
-
-
Campania
-
Naples, Campania, Italia, 80100
- Rekruttering
- University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 1803)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390817463772
-
Naples, Campania, Italia, 80131
- Rekruttering
- Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia ( Site 1800)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +3908117770442
-
-
Catania
-
Misterbianco, Catania, Italia, 95045
- Rekruttering
- Humanitas Istituto Clinico Catanese ( Site 1811)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +39 9573390197
-
-
Forli-Cesena
-
Meldola (FC), Forli-Cesena, Italia, 47014
- Rekruttering
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +39 0543 739100
-
-
Friuli Venezia Giulia
-
Aviano, Friuli Venezia Giulia, Italia, 33081
- Rekruttering
- CRO-IRCCS ( Site 1808)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +39 0434659253
-
-
Lazio
-
Rome, Lazio, Italia, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390630158545
-
-
Lombardy
-
Brescia, Lombardy, Italia, 25123
- Rekruttering
- Azienda Ospedaliera Spedali Civili di Brescia ( Site 1812)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390303996536
-
Milan, Lombardy, Italia, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1801)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390223902597
-
Milan, Lombardy, Italia, 20141
- Rekruttering
- Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1809)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 02 57489970
-
Monza, Lombardy, Italia, 20900
- Rekruttering
- Fondazione IRCCS San Gerardo dei Tintori ( Site 1813)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +39 0392339037
-
-
Tuscany
-
Florence, Tuscany, Italia, 50134
- Rekruttering
- Azienda Ospedaliera Universitaria Careggi ( Site 1805)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390057947264
-
-
-
-
-
Fukushima, Japan, 960-1295
- Rekruttering
- Fukushima Medical University Hospital ( Site 3401)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-24-547-1111
-
Gifu, Japan, 501-1194
- Rekruttering
- Gifu University Hospital ( Site 3426)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-58-230-6000
-
Hiroshima, Japan, 730-8518
- Rekruttering
- Hiroshima City Hiroshima Citizens Hospital ( Site 3418)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-82-221-2291
-
Kagoshima, Japan, 892-0833
- Rekruttering
- Social medical corporation Hakuaikai Sagara Hospital ( Site 3421)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-99-224-1800
-
Kumamoto, Japan, 860-8556
- Rekruttering
- Kumamoto University Hospital ( Site 3420)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-96-344-2111
-
Kyoto, Japan, 606-8507
- Rekruttering
- Kyoto University Hospital ( Site 3415)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-75-751-3111
-
Okayama, Japan, 700-8558
- Rekruttering
- Okayama University Hospital ( Site 3425)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-86-223-7151
-
Osaka, Japan, 541-8567
- Rekruttering
- Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3417)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-6-6945-1181
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 467-8602
- Rekruttering
- Nagoya City University Hospital ( Site 3414)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-52-858-7215
-
-
Chiba
-
Kashiwa, Chiba, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East ( Site 3403)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-4-7133-1111
-
-
Gunma
-
Ōta, Gunma, Japan, 373-8550
- Rekruttering
- Gunma Prefectural Cancer Center ( Site 3428)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-276-38-0771
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-8648
- Rekruttering
- Hokkaido University Hospital ( Site 3400)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-11-716-1161
-
-
Kanagawa
-
Isehara, Kanagawa, Japan, 259-1193
- Rekruttering
- Tokai University Hospital ( Site 3413)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-463-93-1121
-
Kawasaki, Kanagawa, Japan, 216-8511
- Rekruttering
- St. Marianna University Hospital ( Site 3405)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-44-977-8111
-
Sagamihara, Kanagawa, Japan, 252-0375
- Rekruttering
- Kitasato University Hospital ( Site 3411)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-42-778-8111
-
Yokohama, Kanagawa, Japan, 241-8515
- Rekruttering
- Kanagawa Cancer Center ( Site 3412)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-45-520-2222
-
-
Mie-ken
-
Tsu, Mie-ken, Japan, 514-8507
- Rekruttering
- Mie University Hospital ( Site 3423)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-59-231-5246
-
-
Miyagi
-
Sendai, Miyagi, Japan, 980-8574
- Rekruttering
- Tohoku University Hospital ( Site 3422)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-22-717-7000
-
-
Osaka
-
Suita, Osaka, Japan, 565-0871
- Rekruttering
- The University of Osaka Hospital ( Site 3416)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-6-6210-8290
-
-
Saitama
-
Hidaka, Saitama, Japan, 350-1298
- Rekruttering
- Saitama Medical University International Medical Center ( Site 3402)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-42-984-4111
-
-
Tokyo
-
Bunkyo, Tokyo, Japan, 113-8431
- Rekruttering
- Juntendo University Hospital ( Site 3408)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-3-3813-3111
-
Chūō, Tokyo, Japan, 104-8560
- Rekruttering
- St.Luke's International Hospital ( Site 3427)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 03-3541-5151
-
Koto, Tokyo, Japan, 135-8550
- Rekruttering
- Cancer Institute Hospital of JFCR ( Site 3404)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-3-3520-0111
-
Shinagawa, Tokyo, Japan, 142-8666
- Rekruttering
- Showa Medical University Hospital ( Site 3406)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-3-3784-8000
-
Shinjuku, Tokyo, Japan, 160-0023
- Rekruttering
- Tokyo Medical University Hospital ( Site 3407)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-3-3342-6111
-
Shinjuku, Tokyo, Japan, 162-8655
- Rekruttering
- National Center for Global Health and Medicine ( Site 3409)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-3-3202-7181
-
-
-
-
-
Kuala Lumpur, Malaysia, 59100
- Rekruttering
- Pantai Hospital Kuala Lumpur ( Site 2801)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +60327814519
-
Kuala Lumpur, Malaysia, 50450
- Rekruttering
- Prince Court Medical Centre ( Site 2802)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +60321600000
-
-
-
-
Mexico City
-
Benito Juárez, Mexico City, Mexico, 03100
- Rekruttering
- Grupo Médico ASSET SC ( Site 0705)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 5516217417
-
Mexico City, Mexico City, Mexico, 03100
- Rekruttering
- CENEIT Oncologicos ( Site 0706)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 5514817472
-
Mexico City, Mexico City, Mexico, 03100
- Rekruttering
- Health Pharma Professional Research S.A. de C.V: ( Site 0709)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +525575864856
-
Mexico City, Mexico City, Mexico, 04700
- Rekruttering
- COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 0712)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +528008773264
-
-
Nuevo León
-
San Pedro Garza García, Nuevo León, Mexico, 66220
- Rekruttering
- Oncare - Unidad Valle ( Site 0713)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +528182188555
-
San Pedro Garza García, Nuevo León, Mexico, 66278
- Rekruttering
- CENTRO MEDICO ZAMBRANO HELLION ( Site 0711)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +528188880000
-
-
-
-
-
Oslo, Norge, 0379
- Rekruttering
- Oslo universitetssykehus, Radiumhospitalet ( Site 2002)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4722934000
-
-
Buskerud
-
Drammen, Buskerud, Norge, 3004
- Rekruttering
- Drammen Sykehus, Vestre Viken HF ( Site 2001)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4732803000
-
-
Rogaland
-
Stavanger, Rogaland, Norge, 4011
- Rekruttering
- Stavanger Universitetssykehus ( Site 2004)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4751518000
-
-
-
-
Kuyavian-Pomeranian Voivodeship
-
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-796
- Rekruttering
- Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2102)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48523743029
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, Polen, 31-115
- Rekruttering
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 2120)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48225462758
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polen, 02-781
- Rekruttering
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 2100)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48225462486
-
Wieliszew, Masovian Voivodeship, Polen, 05-135
- Rekruttering
- Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 2101)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48227661501
-
-
Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, Polen, 15-027
- Fullført
- Bialostockie Centrum Onkologii ( Site 2105)
-
-
Pomeranian Voivodeship
-
Gdynia, Pomeranian Voivodeship, Polen, 81-519
- Rekruttering
- Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 2113)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48587260105
-
-
Silesian Voivodeship
-
Gliwice, Silesian Voivodeship, Polen, 44-102
- Fullført
- Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 2110)
-
-
West Pomeranian Voivodeship
-
Szczecin, West Pomeranian Voivodeship, Polen, 71-730
- Rekruttering
- Zachodniopomorskie Centrum Onkologii ( Site 2108)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48914251544
-
-
Świętokrzyskie Voivodeship
-
Kielce, Świętokrzyskie Voivodeship, Polen, 25-734
- Rekruttering
- Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 2118)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48885997850
-
-
-
-
-
Lisbon, Portugal, 1649-035
- Rekruttering
- Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2201)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 00351217805000
-
Lisbon, Portugal, 1400-038
- Rekruttering
- Fundacao Champalimaud ( Site 2200)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 00351210480200
-
Porto, Portugal, 4200-072
- Rekruttering
- Instituto Portugues de Oncologia do Porto ( Site 2202)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 00351225084000
-
-
Lisbon District
-
Amadora, Lisbon District, Portugal, 2720-276
- Rekruttering
- Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 2203)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 00351214348200
-
-
-
-
Central Singapore
-
Singapore, Central Singapore, Singapore, 168583
- Rekruttering
- National Cancer Centre Singapore-Medical Oncology ( Site 3002)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6564368000
-
-
-
-
-
Barcelona, Spania, 08035
- Rekruttering
- Hospital Universitari Vall d'Hebron-Oncology ( Site 2300)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34932746000/ 4691
-
Madrid, Spania, 28007
- Rekruttering
- Hospital Beata María Ana-oncology ( Site 2309)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34914097423
-
Madrid, Spania, 28040
- Rekruttering
- Hospital Clinico San Carlos-Oncology Department ( Site 2306)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 34 913303000x7768
-
Valencia, Spania, 46010
- Rekruttering
- HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 2302)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34961973583
-
-
Andalusia
-
Seville, Andalusia, Spania, 41013
- Rekruttering
- HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2304)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 34955013068
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spania, 08908
- Rekruttering
- Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2305)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34 93 260 77 44
-
-
La Coruna
-
A Coruña, La Coruna, Spania, 15006
- Rekruttering
- CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2307)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34981178000
-
-
Madrid, Comunidad de
-
Madrid, Madrid, Comunidad de, Spania, 28034
- Rekruttering
- Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2301)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34913368263
-
Majadahonda, Madrid, Comunidad de, Spania, 28222
- Rekruttering
- HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2308)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34911917358
-
-
Valenciana, Comunitat
-
Valencia, Valenciana, Comunitat, Spania, 46009
- Rekruttering
- Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2303)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +93663224875
-
-
-
-
-
Leeds, Storbritannia, LS9 7TF
- Rekruttering
- St James's University Hospital-Leeds Cancer Centre ( Site 2608)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0113 243 3144
-
-
Bristol, City of
-
Bristol, Bristol, City of, Storbritannia, BS2 8ED
- Rekruttering
- University Hospitals Bristol NHS Foundation Trust ( Site 2601)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 441173426733
-
-
Cambridgeshire
-
Hills Road, Cambridgeshire, Storbritannia, CB2 0QQ
- Rekruttering
- Addenbrooke's Hospital ( Site 2609)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 01223216083
-
-
England
-
Truro, England, Storbritannia, TR1 3LJ
- Rekruttering
- The Royal Cornwall Hospital ( Site 2603)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 01872258345
-
-
London, City of
-
London, London, City of, Storbritannia, EC1A 7BE
- Rekruttering
- St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2602)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +44 20 7377 7000
-
London, London, City of, Storbritannia, NW1 2PG
- Rekruttering
- University College London Hospital ( Site 2604)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +44 20 3456 7890
-
-
Midlothian
-
Edinburgh, Midlothian, Storbritannia, EH4 2XU
- Rekruttering
- Western General Hospital ( Site 2607)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0300 123 1600
-
-
-
-
-
Fribourg, Sveits, 1708
- Rekruttering
- HFR Fribourg - Hôpital Cantonal ( Site 2402)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +41263062260
-
-
Canton of Bern
-
Thun, Canton of Bern, Sveits, 3600
- Rekruttering
- Spital Thun ( Site 2400)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +41 58 636 22 27
-
-
Canton of Geneva
-
Geneva, Canton of Geneva, Sveits, 1206
- Rekruttering
- Clinique Générale-Beaulieu ( Site 2406)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +41228395798
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Sveits, 8008
- Rekruttering
- Brust-Zentrum ( Site 2401)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +41445338141
-
-
Kanton Graubünden
-
Chur, Kanton Graubünden, Sveits, 7000
- Fullført
- Kantonsspital Graubünden-Medizin ( Site 2404)
-
-
-
-
Gävleborg County
-
Gävle, Gävleborg County, Sverige, 801 87
- Rekruttering
- Gävle sjukhus ( Site 3504)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4626154000
-
-
Stockholm County
-
Stockholm, Stockholm County, Sverige, 171 76
- Rekruttering
- Karolinska Universitetssjukhuset Solna ( Site 3500)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +46851770000
-
Stockholm, Stockholm County, Sverige, 112 81
- Rekruttering
- Capio St. Gorans Sjukhus ( Site 3503)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +46858701000
-
-
Uppsala County
-
Uppsala, Uppsala County, Sverige, 751 85
- Rekruttering
- Akademiska Sjukhuset ( Site 3501)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +46186110000
-
-
Västra Götaland County
-
Borås, Västra Götaland County, Sverige, 501 82
- Rekruttering
- Södra Älvsborg Sjukhus ( Site 3502)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +46336161000
-
Gothenburg, Västra Götaland County, Sverige, 413 45
- Rekruttering
- Sahlgrenska Universitetssjukhuset. ( Site 3505)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +46313428503
-
-
-
-
-
Seoul, Sør -Korea, 03080
- Rekruttering
- Seoul National University Hospital-Internal Medicine ( Site 3102)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82-2-2072-0850
-
Seoul, Sør -Korea, 03722
- Rekruttering
- Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3100)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82-2-2228-8135
-
Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center-Department of Oncology ( Site 3103)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +8-2-3010-3216
-
Seoul, Sør -Korea, 06273
- Rekruttering
- Gangnam Severance Hospital, Yonsei University Health System-Medical Oncology, Internal Medicine ( Site 3104)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82-2-2019-3379
-
Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center-Division of Hematology/Oncology ( Site 3101)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82-2-3410-6488
-
-
-
-
Brno-mesto
-
Brno, Brno-mesto, Tsjekkia, 656 53
- Rekruttering
- Masarykuv onkologicky ustav ( Site 1005)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420543134000
-
-
Olomouc Region
-
Olomouc, Olomouc Region, Tsjekkia, 779 00
- Rekruttering
- Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1006)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420588444295
-
-
Praha 2
-
Prague, Praha 2, Tsjekkia, 128 08
- Rekruttering
- Vseobecna fakultni nemocnice v Praze-Onkologická klinika VFN ( Site 1002)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420224966763
-
-
Praha 4
-
Prague, Praha 4, Tsjekkia, 14059
- Rekruttering
- Fakultni Thomayerova nemocnice - Onkologicka klinika 1. LF UK a FTN ( Site 1008)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420261083733
-
-
Praha 5
-
Prague, Praha 5, Tsjekkia, 150 06
- Rekruttering
- Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1000)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420224434701
-
-
South Bohemian Region
-
České Budějovice, South Bohemian Region, Tsjekkia, 37001
- Rekruttering
- Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1007)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420387875001
-
-
-
-
-
Adana, Tyrkia (Türkiye), 01140
- Rekruttering
- Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2501)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +90 322 459 2222
-
Ankara, Tyrkia (Türkiye), 06200
- Rekruttering
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2504)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 03123360909
-
Ankara, Tyrkia (Türkiye), 06520
- Rekruttering
- Memorial Ankara Hastanesi-Medical Oncology ( Site 2502)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +90 312 253 6666
-
Istanbul, Tyrkia (Türkiye), 34214
- Rekruttering
- Medipol Mega Universite Hastanesi-oncology ( Site 2503)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 444 70 44 - 17067
-
Samsun, Tyrkia (Türkiye), 55200
- Rekruttering
- Samsun Medical Park Hastanesi-medical oncology ( Site 2500)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 03623114040
-
-
-
-
-
Berlin, Tyskland, 13125
- Rekruttering
- Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1413)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4930940113394
-
-
Baden-Wurttemberg
-
Freiburg im Breisgau, Baden-Wurttemberg, Tyskland, 79106
- Rekruttering
- Praxis fuer interdisziplinaere Onkologie und Haematologie ( Site 1423)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +49761386870
-
Ludwigsburg, Baden-Wurttemberg, Tyskland, 71640
- Rekruttering
- Klinikum Ludwigsburg-Klinik für Geburtshilfe und Frauenheilkunde ( Site 1405)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4971419996433
-
Tübingen, Baden-Wurttemberg, Tyskland, 72076
- Rekruttering
- Universitaetsklinikum Tuebingen-Frauenklinik ( Site 1415)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4970712964226
-
-
Bavaria
-
Erlangen, Bavaria, Tyskland, 91054
- Rekruttering
- Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1400)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4991318533553
-
Munich, Bavaria, Tyskland, 80336
- Rekruttering
- Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Frauenklinik Brustzentrum ( Site 1402)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4989440034645
-
-
Brandenburg
-
Potsdam, Brandenburg, Tyskland, 14467
- Rekruttering
- Klinikum Ernst von Bergmann-Frauenklinik ( Site 1408)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +493312415602
-
-
Lower Saxony
-
Georgsmarienhütte, Lower Saxony, Tyskland, 49124
- Rekruttering
- Franziskus-Hospital Harderberg ( Site 1404)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +495415022466
-
Hanover, Lower Saxony, Tyskland, 30625
- Rekruttering
- Medizinische Hochschule Hannover ( Site 1419)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +495115329545
-
-
North Rhine-Westphalia
-
Düsseldorf, North Rhine-Westphalia, Tyskland, 40225
- Rekruttering
- Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1409)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +492118117506
-
Essen, North Rhine-Westphalia, Tyskland, 45136
- Rekruttering
- Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1401)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4920117433005
-
Mönchengladbach, North Rhine-Westphalia, Tyskland, 41061
- Rekruttering
- Evangelisches Krankenhaus Bethesda Mönchengladbach-Brustzentrum Niederrhein ( Site 1406)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4921618493577
-
Witten, North Rhine-Westphalia, Tyskland, 58452
- Rekruttering
- Marien Hospital Witten ( Site 1424)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +49 2302 1733290
-
-
Rhineland-Palatinate
-
Mainz, Rhineland-Palatinate, Tyskland, 55131
- Rekruttering
- Universitätsmedizin Johannes Gutenberg Universität Mainz-Klinik und Poliklinik für Geburtshilfe und ( Site 1418)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +496131172683
-
Trier, Rhineland-Palatinate, Tyskland, 54290
- Rekruttering
- Klinikum Mutterhaus der Borromäerinnen ( Site 1420)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4906519470
-
-
Saarland
-
Saarbrücken, Saarland, Tyskland, 66113
- Rekruttering
- CaritasKlinikum Saarbruecken St. Theresia ( Site 1410)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +496814061345
-
-
Schleswig-Holstein
-
Lübeck, Schleswig-Holstein, Tyskland, 23538
- Rekruttering
- Universitätsklinikum Schleswig-Holstein ( Site 1411)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4945150041930
-
-
-
-
-
Salzburg, Østerrike, 5020
- Rekruttering
- Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis ( Site 1202)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +435725525826
-
Vienna, Østerrike, 1090
- Rekruttering
- Medizinische Universität Wien-Universitätsklinik für Innere Medizin I, Klinische Abteilung für Onko ( Site 1201)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4314040064470
-
-
Tyrol
-
Innsbruck, Tyrol, Østerrike, 6020
- Rekruttering
- Medizinische Universitaet Innsbruck ( Site 1200)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +435050423079
-
-
Upper Austria
-
Linz, Upper Austria, Østerrike, 4020
- Rekruttering
- Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1206)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +43576808373652
-
Wels, Upper Austria, Østerrike, 4600
- Rekruttering
- Klinikum Wels-Grieskirchen ( Site 1205)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4372424150
-
-
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
Inclusion Criteria:
- Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
- Has no evidence of locoregional or distant relapse, as assessed by the treating physician
- Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC
- Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery
- Has non-pathologic complete response at surgery
- Is able to continue on adjuvant pembrolizumab
- Randomization must be conducted within 16 weeks from surgical resection
- Completed adjuvant radiation therapy (if indicated) and recovered before randomization
- Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status
- If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine [no restriction for pembrolizumab]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception
- For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention
- Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia)
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization
Exclusion Criteria:
- Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available
- Has Grade >2 peripheral neuropathy
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention
- Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC
- Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy
- Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks
- Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40 [cluster of differentiation (CD) 134], or CD137)
- Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
- Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has concurrent active hepatitis B and hepatitis C virus infection
- Has history of allogeneic tissue/solid organ transplant
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: Pembrolizumab + sacituzumab tirumotecan
Participants receive pembrolizumab every 6 weeks (q6w) in combination with sacituzumab tirumotecan every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sacituzumab tirumotecan infusions. |
Pembrolizumab 400 mg intravenous (IV) infusion q6w
Andre navn:
Sacituzumab tirumotecan 4 mg/kg IV infusion q2w
Andre navn:
|
|
Aktiv komparator: Treatment of Physician's Choice
Participants receive pembrolizumab q6w or pembrolizumab q6w in combination with capecitabine (twice daily [BID] on Days 1 to 14 and 22 to 35 every 42 days x 4 [2 weeks 1, 1 week off]) for 24 weeks. |
Pembrolizumab 400 mg intravenous (IV) infusion q6w
Andre navn:
Capecitabine 1000 mg/m^2 to 1250 mg/m^2 by mouth BID
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Invasive Disease-Free Survival (iDFS)
Tidsramme: Up to ~77 months
|
iDFS is the time from randomization to invasive local, regional, or distant recurrence, invasive contralateral breast cancer, or death due to any cause, whichever occurs first. |
Up to ~77 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: Up to ~101 months
|
OS is the time from randomization to death due to any cause. |
Up to ~101 months
|
|
Distant recurrence-free survival (DRFS)
Tidsramme: Up to ~101 months
|
DRFS is the time from randomization to distant recurrence or death due to any cause, whichever occurs first. |
Up to ~101 months
|
|
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Tidsramme: Baseline and up to ~60 months
|
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life in cancer patients. The overall functioning score is based on participant responses that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status. |
Baseline and up to ~60 months
|
|
Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Tidsramme: Baseline and up to ~60 months
|
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The physical functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better physical functioning. |
Baseline and up to ~60 months
|
|
Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
Tidsramme: Baseline and up to ~60 months
|
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The role functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better role functioning. |
Baseline and up to ~60 months
|
|
Change from baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score
Tidsramme: Baseline and up to ~60 months
|
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1 = "Not at All" to 4 = "Very Much"). Lower scores indicate a better level of fatigue. |
Baseline and up to ~60 months
|
|
Number of participants who experience one or more adverse events (AEs)
Tidsramme: Up to ~42 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to ~42 weeks
|
|
Number of participants who discontinue study intervention due to an AE
Tidsramme: Up to 24 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 24 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
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)
24. juni 2024
Primær fullføring (Antatt)
16. desember 2030
Studiet fullført (Antatt)
14. desember 2037
Datoer for studieregistrering
Først innsendt
26. april 2024
Først innsendt som oppfylte QC-kriteriene
26. april 2024
Først lagt ut (Faktiske)
1. mai 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. november 2026
Sist bekreftet
1. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
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
Andre studie-ID-numre
- 2870-012
- U1111-1289-8264 (Registeridentifikator: UTN)
- jRCT2031240476 (Registeridentifikator: Japan Registry of Clinical Trials (jRCT))
- 2023-504962-52-00 (Registeridentifikator: EU CT)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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. .