Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer (ASCENT-03)
April 3, 2026 updated by: Gilead Sciences
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
623
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, 1426
- Hospital Britanico de Buenos Aires
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CABA, Argentina, 1417
- Instituto de Oncologia Angel H.Roffo
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Capital, Argentina, F5300COE
- Fundación CORI para la Investigación y Prevención del Cáncer
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Rosario, Argentina, 2000
- Instituto de Oncología de Rosario
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San Miguel de Tucumán, Argentina, 4000
- Centro para la Atencion Integral del Paciente Oncologico Centro Médico C.A.I.P.O
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Viedma, Argentina, 8500
- Clinica Viedma
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New South Wales
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Kogarah, New South Wales, Australia, 2217
- Saint George Hospital - Australia
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Mater Misericordiae Limited and Mater Research Limited
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Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Cancer Research Sa (Crsa)
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Medical Centre
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Melbourne, Victoria, Australia, 3084
- Austin Hospital
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Breast Cancer Research Center - Western Australia
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Innsbruck, Austria, 06020
- Medizinische Universitat Innsbruck
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Linz, Austria, 4010
- Ordensklinikum Linz GmbH Barmherzige Schwestern
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Brasschaat, Belgium, 2930
- Algemeen Ziekenhuis klina
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Brussels, Belgium, 1200
- Cliniques Universitaires Saint-luc
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Brussels, Belgium
- Universitair Ziekenhuis Brussel
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Charleroi, Belgium, 6000
- Grand Hôpital De Charleroi - Notre Dame
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Ghent, Belgium, 9000
- Universitair Ziekenhuis Gent
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Leuven, Belgium, 3000
- UZ Leuven
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Namur, Belgium, 5000
- Centre Hospitalier Universitaire Université Cathol
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Goiânia, Brazil, 74605-070
- Hospital Araújo Jorge - Associação de Combate ao Câncer em Goiás - ACCG
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Ijuí, Brazil, 98700-000
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia
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Itajaí, Brazil, 88301-220
- Catarina Pesquisa Clinica
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Porto Alegre, Brazil, 90035-903
- Hospital de Clinicas de Porto Alegre - HCPA
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Porto Alegre, Brazil, 90610001
- Hospital Sao Lucas da PUCRS
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Porto Alegre, Brazil, 90035-00
- Hospital Moinhos de Vento
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Rio de Janeiro, Brazil
- Instituto Nacional de Câncer - INCA - HCIII
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Salvador, Brazil, 40170170
- Nucleo de Oncologia da Bahia
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Santo André, Brazil, 09060-650
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
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São Paulo, Brazil, 1317000
- Clinica de Pesquisas e Centro de Estudos em Oncolo
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São Paulo, Brazil, 4014002
- Núcleo de Pesquisa Clínica da Rede São Camilo
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São Paulo, Brazil, 01323-001
- Real e Portuguesa de Beneficéncia - Hospital Beneficéncia Portuguesa (BP) - Unidade Paulista
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São Paulo, Brazil, 14784400
- Fundação Pio XII - Hospital de Amor de Barretos
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São Paulo, Brazil, 17210080
- Hospital Amaral Carvalho
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Edmonton, Canada, T6G 1Z2
- Cross Cancer Institute
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Halifax, Canada, B3H 1V7
- QEII Health Sciences Centre
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Kitchener, Canada, N2G 1G3
- Grand River Regional Cancer Centre at Grand River Hospital
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London, Canada, N6A 5W9
- London Health Sciences Centre
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Montreal, Canada, H4A 3J1
- McGill University Health Centre
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Montreal, Canada, H3T 1E2
- Jewish General Hospital Department of Medical Oncology
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Ottawa, Canada, K1H 8L6
- Ottawa Hospital - General Campus
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Toronto, Canada, M5G 1X5
- Mount Sinai Hospital
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Toronto, Canada, M4N 3M5
- Sunnybrook Research Institute
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Providencia, Chile, 7510035
- Oncovida - Santiago
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Santiago, Chile
- Clinica IRAM
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Santiago, Chile, 7630000
- Clinica Alemana
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Santiago Region, Chile, 8330032
- Centro de Oncología de Precisión
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Temuco, Chile
- James Lind Centro de Investigacion del Cancer
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Beijing, China, 100142
- Beijing Cancer Hospital
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Beijing, China, 100044
- Peking University People's Hospital
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Beijing, China, 100021
- Cancer Hospital Chinese Academy of Medical Sciences
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Beijing, China, 100853
- The First Medical Center of Chinese PLA General Hospital
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Changsha, China, 410011
- The second Xiangya hospital of central south university
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Chengdu, China, 610041
- West China Hospital, Sichuan University
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Chengdu, China, 610041
- Sichuan Cancer Hospital
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Chongqing, China, 400016
- The First Affiliated Hospital of Chongqing Medical University
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Chongqing, China, 404100
- Chongqing University Cancer Hospital
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Deyang, China, 618000
- Deyang People's Hospital
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Guangzhou, China, 510000
- Sun Yat-sen University Cancer Center
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Hangzhou, China, 31006
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Harbin, China, 150081
- Harbin Medical University Cancer Hospital
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Hefei, China, 230031
- Anhui Provincial Cancer Hospital
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Hefei, China, 230601
- The Second Hospital of Anhui Medical University
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Jilin Sheng, China, 130041
- The Second Hospital of Jilin University
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Jinan, China, 250117
- Shandong Cancer Hospital
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Jinan, China, 250033
- The Second Hospital of Shandong University
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Nanchang, China, 330200
- Nanchang People's Hospital
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Nanning, China, 530021
- The First Affiliated Hospital of Guangxi Medical University
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Tianjin, China, 453000
- Tianjin Medical University Cancer Institute& Hospital
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Weihai, China, 264299
- Weihai Municipal Hospital
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Wuhan, China, 430022
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Wuhan, China, 430000
- Hubei Cancer Hospital
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Wuhan, China, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Xi'an, China, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
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Zhejiang, China, 310009
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Zhejiang, China, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Brno, Czechia, 65653
- Masarykuv onkologicky ustav, klinika komplexni onkologickie pece
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Hradec Králové, Czechia, 500 05
- Fakultni nemocnice Hradec Kravlove, Klinika onkologie a radioterapie
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Hradec Králové, Czechia, 50005
- Fakultni Thomayerova nemocnice
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Olomouc, Czechia, 77520
- Fakultni nemocnice Olomouc, Onkologicka klinika
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Prague, Czechia, 12808
- Vseobecna fakultni nemocnice v Praze
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Prague, Czechia, 100 34
- Fakultni nemocnice Karlovske Vinohrady, Radioterapeuticka a onkologicka klinika
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Avignon, France, 84918
- Sainte Catherine Institut du Cancer Avignon Provence
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Besançon, France, 25030
- Centre Hospitalier Régional et Universitaire de Be
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Brest, France, 29200
- Hôpital Morvan, Institut de cancérologie
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Caen, France, 14000
- Centre Francois Baclesse
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
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Montpellier, France, 34070
- Centre de Cancerologie du Grand Montpellier
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Nantes, France, 44202
- Hôpital Privé du Confluent
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Pierre-Bénite, France, 69310
- Hospices Civils de Lyon Hôpital Lyon Sud
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Plérin, France, 22190
- Centre Armoricain de Radiothérapie, dImagerie Méd
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Rennes, France, 35042
- Centre Eugène Marquis
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Toulouse, France
- Institut Claudius Regaud - IUCT-O
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Villejuif, France, 94800
- Institut Gustave Roussy
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Berlin, Germany, 13125
- Helios Klinikum Berlin-Buch
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Bonn, Germany, 53111
- Gynakologisches Zentrum Bonn, Schwerpunkt Gyn. Onkologie,
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Cologne, Germany, 50937
- Klinik Frauenheilkunde, Uniklinik ClO, Studienzentrale
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Essen, Germany, 45136
- Kliniken Essen-Mitte - Evangelische Huyssens-Stift Breast Unit
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Hamburg, Germany, 20246
- Universitatsklinikum Hamburg-Eppendorf
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Heidelberg, Germany, 69120
- Nationales Centrum für Tumorerkrankungen - Heidelb
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Lübeck, Germany, 23538
- Universitätsklinikum Schleswig-Holstein Institut fur Klinische Chermie
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Mannheim, Germany, 68167
- Universitatsklinikum Mannheim GmBH, Frauenklinik
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Tübingen, Germany, 72076
- Universitatsklinikum Tubingen
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Hong Kong, Hong Kong
- Queen Mary Hospital
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Hong Kong, Hong Kong
- Tuen Mun Hospital
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Pok Fu Lam, Hong Kong
- Queen Mary Hospital
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Budapest, Hungary, 1145
- Uzsoki Utcai Kornaz, Onkoradiologiai Osztaly
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Debrecen, Hungary, 4032
- Debreceni Egyetem Klinikai Kozpont
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Győr, Hungary, 9024
- Petz Aladar Egyetemi Oktaté Kérhaz - Osztaly
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Haifa, Israel, 3109601
- Rambam Health Care Campus
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Jerusalem, Israel
- Hadassah - Hebrew University Medical Center
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Kfar Saba, Israel, 4428164
- Meir Medical Center
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Petah Tikva, Israel, 4941492
- Rabin Medical Center
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Rehovot, Israel, 7661041
- Kaplan Medical Center
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
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Tel Aviv, Israel, 52621
- Sheba Medical Center Hospital - Tel Hashomer
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Bari, Italy, 70124
- IRCCS Istituto Tumori "G.Paolo II"
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Bologna, Italy
- SSD Oncologia Medica Addarii-Zamagni, IRCSS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
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Brescia, Italy, 25123
- UO Oncologia, ASST degli Spedali Civili di Brescia
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Genova GE, Italy, 16132
- IRCSS Ospedale Policlinico San Martino
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Lecco, Italy, 23900
- S.C. Oncologia medica, ASST di Lecco
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Lucca, Italy, 55100
- Presidio Ospedaliero di Lucca
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Macerata, Italy, 62100
- Ospedale Generale Provinciale - Macerata
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Milan, Italy, 20141
- Istituto Europeo di Oncologia
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Milan, Italy, 20133
- Fondazione IRCCS - Istituto Nazionale dei Tumori
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Monza, Italy, 20090
- Azienda Socio Sanitaria Territoriale
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Naples, Italy, 80131
- Oncologia Medica Senologica Sperimentale - Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
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Novara, Italy, 28100
- Azienda Ospedaliero-Universitaria Maggiore della C
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Padova, Italy, 35128
- Istituto Oncologico Veneto - IRCCS
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Roma, Italy, 00161
- AOU Policlinico Umberto I
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Rome, Italy, 00168
- Fondazione Policlinico Universitario Agostino Geme
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Aichi, Japan, 464-8681
- Aichi Cancer Center Hospital
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Bunkyō City, Japan, 113-8431
- Juntendo University Hospital
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Chūōku, Japan, 260-8717
- Chiba Cancer Center
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Ehime, Japan, 791-0280
- Shikoku Cancer Center
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Kagoshima, Japan, 892-0833
- Hakuaikai Sagara Hospital
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Kashiwa, Japan, 277-8577
- National Cancer Center Hospital East
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Kumamoto, Japan, 860-8556
- Kumamoto University Hospital
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Kure, Japan, 737-0023
- Kure Medical Center and Chugoku Cancer Center
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Kōtoku, Japan, 135-8550
- Cancer Institute Hospital of JFCR
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Minamiku, Japan, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Nagoya, Japan, 466-8560
- Nagoya University Hospital
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Nakaku, Japan, 730-8518
- Hiroshima City Hiroshima Citizens Hospital
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Okayama, Japan, 700-8558
- Okayama University Hospital
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Sakyo-ku, Japan, 606-8507
- Kyoto University Hospital
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Sapporo, Japan, 003-0804
- Hokkaido Cancer Center
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Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
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Shizuoka, Japan, 420-8527
- Shizuoka General Hospital
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Suita, Japan, 565-0871
- Osaka University Hospital
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Tokyo, Japan, 142-8555
- Showa University Hospital
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Yokohama, Japan, 241-8515
- Kanagawa Cancer Center
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George Town, Malaysia, 10450
- Hospital Pulau Pinang
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Johor Bahru, Malaysia, 81100
- Hospital Sultan Ismail
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Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre (UMMC)
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Kuala Lumpur, Malaysia, 59100
- Pantai Hospital Kuala Lumpur
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Kuala Lumpur, Malaysia, 47500
- Hospital Kuala Lumpur
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Putrajaya, Malaysia, 62250
- Institut Kanser Negara
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Sarawak, Malaysia, 93586
- Sarawak General Hospital
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Chihuahua City, Mexico, 31000
- Icaro Investigaciones en Medicina
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Culiacán, Mexico, 80230
- Sinacor - Centro para el Desarrollo de la Medicina
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Guadalajara, Mexico, 44670
- PanAmerican Clinical Research Mexico - Guadalajara
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Mexico City, Mexico, 06100
- Cryptex Investigación Clínica
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Monterrey, Mexico, 64710
- Avix Investigacion Clinica S.C.
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Mérida, Mexico, 97070
- Medical Care and Research S.A. de C.V.
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México, Mexico, 4980
- Fucam A.C.
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San Luis Potosí City, Mexico, 78209
- Oncologico Potosino
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Veracruz, Mexico, 91900
- FAICIC Clínical Research
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Zapopan, Mexico, 45070
- iBiomed - Investigacion Biomedica para el Desarrol
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Breda, Netherlands, 4818 CK
- Amphia Ziekenhuis - Breda Langendijk
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Groningen, Netherlands, 9700 RB
- Universitair Medisch Centrum Groningen
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Leeuwarden, Netherlands, 8934 AD
- Medisch Centrum Leeuwarden
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Maastricht, Netherlands, 6229HX
- Maastricht Universitair Medisch Centrum
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Rotterdam, Netherlands
- Erasmus Medisch Centrum
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Gdansk, Poland, 80-952
- Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
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Gliwice, Poland, 44-102
- Narodowy Instytut Onkologii im. Marii Sklodowskiej
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Opole, Poland, 45-061
- SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego
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Siedlce, Poland, 08-110
- Mazowiecki Szpital Wojewódzki im. w. Jana Pawa II
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Warsaw, Poland, 02-781
- Narodowy Instytut Onkologii im.Marii Marii Sklodowskiej
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Bucharest, Romania, 11171
- Spitalul Clinic Filantropia
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Cluj-Napoca, Romania, 400058
- SC Medisprof SRL
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Cluj-Napoca, Romania, 400150
- Institutal Oncologic, Prof. Dr Ion Chiricuta
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Craiova, Romania, 200642
- Centrul de Oncologie Sf Nectarie
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Bratislava, Slovakia, 83310
- Narodny onkologicky ustav
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Bratislava, Slovakia, 81250
- Onkologicky Ustav sv. Alzbety
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Partizánske, Slovakia, 95801
- Nemocnica Partizánske
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Hilton, South Africa, 3245
- Hopelands Cancer Centre
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Johannesburg, South Africa, 2192
- Wits Clinical Research
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Johannesburg, South Africa, 2196
- The Medical Oncology Centre of Rosebank
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Goyang-si Gyeonggi-do, South Korea, 10408
- National Cancer Center
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Seongnam-si, South Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, South Korea, 05505
- Asan Medical Center
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Seoul, South Korea, 06351
- Samsung Medical Center
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Seoul, South Korea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, South Korea, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, South Korea, 3080
- Seoul National University Hospital
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Seoul, South Korea, 2841
- Korea University Anam Hospital
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A Coruña, Spain, 15006
- Hospital Teresa Herrera - Materno Infantil
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Barcelona, Spain, 08028
- Hospital Universitari Dexeus
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Barcelona, Spain, 8035
- Hospital Universitari Vall d'Hebron
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Barcelona, Spain, 8041
- Hospital De La Santa Creu I Sant Pau
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Bilbao, Spain, 48013
- Hospital Universitario de Basurto
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Lleida, Spain, 25198
- Hospital Universitari Arnau de Vilanova
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Madrid, Spain, 28040
- Hospital Universitario Fundacion Jimenez Díaz
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Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañon
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Madrid, Spain, 28033
- MD Anderson Cancer Center Madrid
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Murcia, Spain, 30008
- Hospital General Universitario Morales Meseguer
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Seville, Spain, 41013
- Hospital Unviersitario Virgen del Rocio
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Seville, Spain, 41071
- Hospital Universitario Virgen Macarena
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Valencia, Spain, 46010
- Hospital Clínico Universitario de Valencia
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Sankt Gallen, Switzerland, 9007
- Kantonsspital St.Gallen
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Hualien City, Taiwan, 970
- Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital
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Tainan, Taiwan, 73657
- Chi Mei Hospital, Lioying
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Taipei, Taiwan, 10048
- National Taiwan University Hospital
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Taipei, Taiwan, 104217
- MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital
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Taoyuan, Taiwan, 33305
- Chang Gung Memorial Hospital, Linkou
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Adana, Turkey (Türkiye), 1120
- Baskent Uni. Dr Turgut Noyan Uyg. ve Aras. Merkezi
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Ankara, Turkey (Türkiye), 06520
- Memorial Ankara Hastanesi
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Ankara, Turkey (Türkiye), 6010
- Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve A
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Ankara, Turkey (Türkiye), 6200
- Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
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Ankara, Turkey (Türkiye)
- Hacettepe Universitesi Hastanesi
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Edirne, Turkey (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi Hastanesi
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Istanbul, Turkey (Türkiye), 34000
- Istanbul Il Saglik Mudurlugu Goztepe Prof. Dr. Sul
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Istanbul, Turkey (Türkiye), 34214
- Medipol Mega Universite Hastanesi
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Izmir, Turkey (Türkiye), 35100
- Ege Universitesi Hastanesi
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Izmir, Turkey (Türkiye), 35575
- Medicana International Izmir Hastanesi
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Yellowplace, Turkey (Türkiye)
- Acibadem Maslak Hastanesi
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Leeds, United Kingdom, LS9 7TF
- Leeds Teaching Hospitals NHS Trust
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London, United Kingdom, EC1M 6BQ
- Barts Health NHS Trust
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London, United Kingdom, WC1E 6BT
- University College London Hospitals NHS Foundation
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Arizona
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Tucson, Arizona, United States, 85711
- Arizona Oncology Associates, PC-Hope
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Tucson, Arizona, United States, 85704
- Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd
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Tucson, Arizona, United States, 85704
- Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd.
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Tucson, Arizona, United States, 85745
- Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road
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California
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Burbank, California, United States, 91505
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200
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La Jolla, California, United States, 92093
- University of California San Diego Moores Cancer
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Laguna Hills, California, United States, 91505
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200
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San Luis Obispo, California, United States, 93401
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240
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Santa Monica, California, United States, 90404
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600
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Santa Monica, California, United States, 90404
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304
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Santa Monica, California, United States, 90404
- University of California Los Angeles - Jonsson Comprehensive Cancer Center
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Torrance, California, United States, 90505
- Torrance Memorial Physician Network - Cancer Care
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Westlake Village, California, United States, 91361
- University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100
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Colorado
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Aurora, Colorado, United States, 80012
- Rocky Mountain Cancer Centers,1700 South Potomac Street
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Boulder, Colorado, United States, 80303
- Rocky Mountain Cancer Centers
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Colorado Springs, Colorado, United States, 80907
- Rocky Mountain Cancer Centers,2312 N. Nevada Avenue
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Colorado Springs, Colorado, United States, 80923
- Rocky Mountain Cancer Centers,6031 E. Woodman Rd.
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Denver, Colorado, United States, 80220
- Rocky Mountain Cancer Centers,4700 E. Hale Parkway
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Lakewood, Colorado, United States, 80228
- Rocky Mountain Cancer Centers,11750 West 2nd Place
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Littleton, Colorado, United States, 80120
- Rocky Mountain Cancer Centers,22 West Dry Creek Circle
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Lone Tree, Colorado, United States, 80124
- Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway
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Longmont, Colorado, United States, 80124
- Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210
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Pueblo, Colorado, United States, 81008
- Rocky Mountain Cancer Centers,3676 Parker Blvd
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Pueblo, Colorado, United States, 81008
- Rocky Mountain Cancer Centers,525 W. 15th Street
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Thornton, Colorado, United States, 80260
- Rocky Mountain Cancer Centers,8820 Huron Street
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Florida
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Altamonte Springs, Florida, United States, 32701
- AdventHealth Medical Group
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Altamonte Springs, Florida, United States, 32701
- Florida Cancer Specialists - North Region Research Office,750 Orienta Ave
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Bonita Springs, Florida, United States, 34135
- Florida Cancer Specialists,9776 Bonita Beach Road Southeast Suite 201 A
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Bradenton, Florida, United States, 34205
- Florida Cancer Specialists,3630 Manatee Avenue West
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Bradenton, Florida, United States, 34211
- Florida Cancer Specialists,5985 Silver Falls Run
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Brandon, Florida, United States, 33511
- Florida Cancer Specialists - North Region Research Office,403 S. Kings Ave.
-
Cape Coral, Florida, United States, 33909
- Florida Cancer Specialists,1030 Commerce Creek Blvd
-
Clearwater, Florida, United States, 33761
- Florida Cancer Specialists - North Region Research Office,3280 McMullen Booth Road
-
Fort Myers, Florida, United States, 33901
- Florida Cancer Specialists
-
Fort Myers, Florida, United States, 33905
- Florida Cancer Specialists,8981 Colonial Center Drive
-
Fort Myers, Florida, United States, 33908
- Florida Cancer Specialists,8260 Gladiolus Dr
-
Gainesville, Florida, United States, 32605
- Florida Cancer Specialists - North Region Research Office,6420 W. Newberry Road
-
Largo, Florida, United States, 33770
- Florida Cancer Specialists - North Region Research Office,100 Highland Avenue
-
Lecanto, Florida, United States, 34461
- Florida Cancer Specialists - North Region Research Office,521 North Lecanto Highway
-
Naples, Florida, United States, 34102
- Florida Cancer Specialists,1100 Goodlette Road
-
Naples, Florida, United States, 34102
- Florida Cancer Specialists,681 4th Avenue North
-
Ocala, Florida, United States, 34474
- Florida Cancer Specialists - North Region Research Office,4945 SW 49th Place
-
Orange City, Florida, United States, 32763
- Florida Cancer Specialists - North Region Research Office,2824 Enterprise Rd
-
Orlando, Florida, United States, 32804
- AdventHealth Medical Group,2501 North Orange Ave
-
Orlando, Florida, United States, 32806
- Florida Cancer Specialists - North Region Research Office,70 W. Gore Street
-
Port Charlotte, Florida, United States, 33980
- Florida Cancer Specialists,22395 Edgewater Drive
-
Sarasota, Florida, United States, 34232
- Florida Cancer Specialists,600 North Cattlemen Road
-
Sarasota, Florida, United States, 34236
- Florida Cancer Specialists,1970 Golf Street
-
Spring Hill, Florida, United States, 34608
- Florida Cancer Specialists - North Region Research Office,7154 Medical Center Drive
-
St. Petersburg, Florida, United States, 33705
- Florida Cancer Specialists - North Region Research Office,1201 Fifth Avenue North
-
St. Petersburg, Florida, United States, 33705
- Florida Cancer Specialists - North Region Research Office
-
Tampa, Florida, United States, 33607
- Florida Cancer Specialists - North Region Research Office,3402 West Dr. Martin Luther King Jr. Boulevard
-
Tavares, Florida, United States, 32778
- Florida Cancer Specialists - North Region Research Office,4100 Waterman Way
-
The Villages, Florida, United States, 32159
- Florida Cancer Specialists - North Region Research Office,1400 US Highway 441 N
-
Trinity, Florida, United States, 34655
- Florida Cancer Specialists - North Region Research Office,9320 State Road 54
-
Venice, Florida, United States, 34292
- Florida Cancer Specialists,836 Sunset Lake Blvd
-
Venice, Florida, United States, 34285
- Florida Cancer Specialists,901 South Tamiami Trail
-
Winter Park, Florida, United States, 32789
- Florida Cancer Specialists - North Region Research Office,460 N Orlando Ave
-
-
Georgia
-
Athens, Georgia, United States, 30606
- Northside Hospital,125 King Avenue
-
Atlanta, Georgia, United States, 30342
- Northside Hospital
-
Atlanta, Georgia, United States, 30342
- Northside Hospital,5670 Peachtree Dunwoody Rd.
-
Blairsville, Georgia, United States, 30512
- Northside Hospital,308 Deep South Farm Rd, Suite 200
-
Canton, Georgia, United States, 30114
- Northside Hospital,228 Riverstone Dr.
-
Carrollton, Georgia, United States, 30117
- Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,157 Clinic Avenue
-
Cartersville, Georgia, United States, 30121
- Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,100 Market Place Blvd
-
Cumming, Georgia, United States, 30041
- Northside Hospital,1505 Northside Blvd, Suite 4600
-
Duluth, Georgia, United States, 30096
- Northside Hospital,3855 Pleasant Hill Rd., Suite 480
-
Macon, Georgia, United States, 31217
- Northside Hospital,308 Coliseum Dr.
-
Marietta, Georgia, United States, 30060
- Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University
-
DeKalb, Illinois, United States, 60115
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1 Kish Hospital Drive
-
DeKalb, Illinois, United States, 60115
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,10 Health Services Drive
-
Geneva, Illinois, United States, 60134
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,300 Randall Road
-
Geneva, Illinois, United States, 60134
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,304 Randall Road
-
Lake Forest, Illinois, United States, 60045
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1000 N. Westmoreland Road
-
Warrenville, Illinois, United States, 25731
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4405 Weaver Parkway
-
Warrenville, Illinois, United States, 60555
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4455 Weaver Parkway
-
Winfield, Illinois, United States, 60190
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University,25 N Winfield Road
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
-
-
Kentucky
-
Louisville, Kentucky, United States, 40207
- Norton Cancer Institute - Saint Matthews
-
Louisville, Kentucky, United States, 40202
- Norton Cancer Institute - Saint Matthews,234 E. Gray Strret
-
Louisville, Kentucky, United States, 40202
- Norton Cancer Institute - Saint Matthews,676 S. Floyd Street
-
Louisville, Kentucky, United States, 40241
- Norton Cancer Institute - Saint Matthews,4955 Norton Healthcare Blvd
-
-
Maryland
-
Baltimore, Maryland, United States, 21229
- Cancer Institute Ascension Saint Agnes
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
-
-
Mississippi
-
Southaven, Mississippi, United States, 38671
- The West Clinic, PLLC dba West Cancer Center,7668 Airways Blvd
-
-
New York
-
Babylon, New York, United States, 11702
- New York Cancer & Blood Specialists - Port Jeffers,72 East Main St.
-
New Hyde Park, New York, United States, 11042
- New York Cancer & Blood Specialists - Port Jeffers,1 Delaware Dr.
-
Patchogue, New York, United States, 11772
- New York Cancer & Blood Specialists - Port Jeffers,365 East Main St.
-
Port Jefferson, New York, United States, 11776
- New York Cancer & Blood Specialists - Port Jeffers,1500 Rte, 112, Building 4
-
Port Jefferson Station, New York, United States, 11776
- New York Cancer & Blood Specialists - Port Jeffers,49 Rte. 347, Newconset Hwy
-
Port Jefferson Station, New York, United States, 11776
- New York Cancer & Blood Specialists - Port Jeffers
-
Riverhead, New York, United States, 11901
- New York Cancer & Blood Specialists - Port Jeffers,750 Old County Rd. Suite 4
-
The Bronx, New York, United States, 10028
- New York Cancer & Blood Specialists - Port Jeffers,12 East 86th St, Suite 4
-
The Bronx, New York, United States, 10469
- New York Cancer & Blood Specialists - Port Jeffers,2330 Eastchester Road, Suite 360
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Novant Health Cancer Institute - Forsyth,125 Queens Road, Suite 650
-
Wilmington, North Carolina, United States, 28401
- Novant Health Cancer Institute - Forsyth,2131 S. 17th Street
-
Winston-Salem, North Carolina, United States, 27103
- Novant Health Cancer Institute - Forsyth
-
-
Pennsylvania
-
Erie, Pennsylvania, United States, 16505
- Magee-Womens Hospital of UPMC,2500 West 12th Street
-
Erie, Pennsylvania, United States, 16550
- Magee-Womens Hospital of UPMC,201 State Street, 6 Main
-
Harrisburg, Pennsylvania, United States, 17109
- Magee-Womens Hospital of UPMC,4300 Londonberry Road
-
Mechanicsburg, Pennsylvania, United States, 17050
- Magee-Womens Hospital of UPMC,2035 Technology Parkway
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Abramson Cancer Center
-
Pittsburgh, Pennsylvania, United States, 15213
- Magee-Womens Hospital of UPMC
-
Pittsburgh, Pennsylvania, United States, 15232
- Magee-Womens Hospital of UPMC,5115 Centre Avenue
-
York, Pennsylvania, United States, 17408
- Magee-Womens Hospital of UPMC,1703 Innovation Drive
-
-
Tennessee
-
Dickson, Tennessee, United States, 37055
- Tennessee Oncology, PLLC,103 Natchez Park Drive
-
Franklin, Tennessee, United States, 37067
- Tennessee Oncology, PLLC,4488 Carothers Parkway
-
Gallatin, Tennessee, United States, 37066
- Tennessee Oncology, PLLC,225 Big Station Camp Blvd
-
Germantown, Tennessee, United States, 38138
- The West Clinic, PLLC dba West Cancer Center
-
Hendersonville, Tennessee, United States, 37075
- Tennessee Oncology, PLLC,353 New Shackle Island Road
-
Hermitage, Tennessee, United States, 37076
- Tennessee Oncology, PLLC,5653 First Blvd.
-
Lebanon, Tennessee, United States, 37090
- Tennessee Oncology, PLLC,103 Physicians Way
-
Murfreesboro, Tennessee, United States, 37129
- Tennessee Oncology, PLLC,1840 Medical Center Parkway
-
Nashville, Tennessee, United States, 37203
- Tennessee Oncology, PLLC
-
Nashville, Tennessee, United States, 37203
- Tennessee Oncology, PLLC,2004 Hayes Street
-
Nashville, Tennessee, United States, 37203
- Tennessee Oncology, PLLC,SCRI Oncology Partners
-
Nashville, Tennessee, United States, 37205
- Tennessee Oncology, PLLC,4220 Harding Rd
-
Nashville, Tennessee, United States, 37207
- Tennessee Oncology, PLLC,3443 Dickerson Road
-
Nashville, Tennessee, United States, 37211
- Tennessee Oncology, PLLC,397 Wallace Road
-
Shelbyville, Tennessee, United States, 37160
- Tennessee Oncology, PLLC,120 Frank Martin Road
-
Smyrna, Tennessee, United States, 37167
- Tennessee Oncology, PLLC,300 Stonecrest Blvd
-
-
Texas
-
Austin, Texas, United States, 78705
- Texas Oncology PA,901 West 38th Street
-
Austin, Texas, United States, 78731
- Texas Oncology Pa
-
Austin, Texas, United States, 78745
- Texas Oncology PA,4101 James Casey, Suite 100
-
-
Virginia
-
Chesapeake, Virginia, United States, 23320
- Virginia Oncology Associates,744 N. Battlefield Blvd
-
Newport News, Virginia, United States, 23606
- Virginia Oncology Associates,1051 Loftis Blvd Suite 100
-
Norfolk, Virginia, United States, 23502
- Virginia Oncology Associates
-
Virginia Beach, Virginia, United States, 23456
- Virginia Oncology Associates,1950 Glenn Mitchell Drive
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria:
Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
- Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity
- Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
- Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence
- Individuals presenting with de novo metastatic TNBC are eligible
- Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Demonstrates adequate organ function
- Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
- Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease
Key Exclusion Criteria:
- Positive serum pregnancy test or women who are lactating
- Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
- Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
- May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible
- Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
- Active second malignancy
- Active serious infection requiring antibiotics
- Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sacituzumab Govitecan-hziy (SG)
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle.
|
Administered intravenously
Other Names:
|
|
Active Comparator: Treatment of Physician's Choice (TPC)
Participants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens:
|
Administered intravenously
Administered intravenously
Administered intravenously
Other Names:
Administered intravenously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time Frame: Randomization up to approximately 57 months
|
PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD), or death (whichever comes first).
|
Randomization up to approximately 57 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: Randomization up to approximately 57 months
|
OS is defined as the time from the date of randomization until death due to any cause.
|
Randomization up to approximately 57 months
|
|
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Time Frame: Randomization up to approximately 57 months
|
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
|
Randomization up to approximately 57 months
|
|
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Time Frame: Randomization up to approximately 57 months
|
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD or death from any cause (whichever comes first).
|
Randomization up to approximately 57 months
|
|
Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1
Time Frame: Randomization up to approximately 57 months
|
TTR is defined as the time from the date of randomization until the first documentation of CR or PR.
|
Randomization up to approximately 57 months
|
|
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame: First dose date up to approximately 57 months plus 30 days
|
First dose date up to approximately 57 months plus 30 days
|
|
|
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time Frame: First dose date up to approximately 57 months plus 30 days
|
First dose date up to approximately 57 months plus 30 days
|
|
|
Change from Baseline in the Physical Functioning Domain as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30).
Time Frame: Randomization up to approximately 57 months
|
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) to assess 15 scales; 1 global health status/quality of life (QOL), 5 functional scales (physical, role, cognitive, emotional, and social), and 9 symptom/item scales(fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
All of the scales and single-item measures range in score from 0 to 100.
A high scale score represents a higher response level.
Thus, a high score for a functional scale represents a high/healthy level of function, a high score for the global health status/QOL represents a high QOL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
|
Randomization up to approximately 57 months
|
|
Time to Deterioration (TTD) of Fatigue Scale of the EORTC QLQ-C30
Time Frame: Randomization up to approximately 57 months
|
TTD is defined as the time between the date of randomization and the date of assessment at which a patient experienced a deterioration (≥ 10 points deterioration from baseline in the fatigue scale) or death.
|
Randomization up to approximately 57 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2022
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Study Registration Dates
First Submitted
May 16, 2022
First Submitted That Met QC Criteria
May 16, 2022
First Posted (Actual)
May 19, 2022
Study Record Updates
Last Update Posted (Actual)
April 6, 2026
Last Update Submitted That Met QC Criteria
April 3, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Breast Diseases
- Breast Neoplasms
- Skin and Connective Tissue Diseases
- Triple Negative Breast Neoplasms
- Amino Acids, Peptides, and Proteins
- Proteins
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Hydrocarbons
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Terpenes
- Coordination Complexes
- Taxoids
- Cyclodecanes
- Diterpenes
- Deoxycytidine
- Cytidine
- Pyrimidine Nucleosides
- Pyrimidines
- Albumins
- Albumin-Bound Paclitaxel
- Gemcitabine
- Carboplatin
- Paclitaxel
- 130-nm albumin-bound paclitaxel
- sacituzumab govitecan
Other Study ID Numbers
- GS-US-592-6238
- 2021-005743-79 (EudraCT Number)
- DOH-27082022-7958 (Registry Identifier: South African National Clinical Trials Registry)
- jRCT2041220122 (Registry Identifier: Japan Registry of Clinical Trials)
- CTR20234162 (Registry Identifier: China: Drug Clinical Trial Registration and Information Disclosure Platform)
- 2023-504195-14 (Other Identifier: European Medicines Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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