A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)

May 28, 2026 updated by: Bristol-Myers Squibb

IZABRIGHT-Breast01: A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1122
        • Recruiting
        • Instituto Argentino de Diagnóstico y Tratamiento (IADT)
        • Contact:
          • Juan Cundom, Site 0345
          • Phone Number: (+54911)4162-5353
      • Buenos Aires, Argentina, 1426
        • Recruiting
        • Instituto Alexander Fleming
        • Contact:
          • Adrian Nervo, Site 0012
          • Phone Number: +54932218900
      • Buenos Aires, Argentina, 1426
        • Recruiting
        • Centro Oncologico Korben
        • Contact:
          • Ernesto Korbenfeld, Site 0317
          • Phone Number: 54911563819972
      • Buenos Aires, Argentina, 1430
        • Not yet recruiting
        • Local Institution - 0346
        • Contact:
          • Site 0346
      • Mendoza, Argentina, 5500
        • Recruiting
        • Fundación Oncológica Mendoza
        • Contact:
          • RUBEN RIZZO, Site 0348
          • Phone Number: +5492615109921
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1280
        • Not yet recruiting
        • Local Institution - 0011
        • Contact:
          • Site 0011
    • Buenos Aires F.D.
      • ABB, Buenos Aires F.D., Argentina, 1181
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • Maria Riggi, Site 0214
          • Phone Number: 5491165379382
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5004BAL
        • Recruiting
        • Hospital Italiano de Córdoba
        • Contact:
          • Virginia Garcia, Site 0143
          • Phone Number: +5493515054293
      • Río Cuarto, Córdoba Province, Argentina, X5800ALB
        • Recruiting
        • Centro Privado de RMI Río Cuarto S.A. II
        • Contact:
          • Alejo Lingua, Site 0137
          • Phone Number: 54351153819050
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Recruiting
        • Sanatorio Plaza
        • Contact:
          • Miriam Raimondo, Site 0142
          • Phone Number: +549341644-8821
  • Australia
    • New South Wales
      • Macquarie University, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University
        • Contact:
          • Dhanusha Sabanathan, Site 0170
          • Phone Number: 98122973
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women's Hospital
        • Contact:
          • Po-ling Inglis, Site 0035
          • Phone Number: 61736468111
    • Victoria
      • Ballarat Central, Victoria, Australia, 3350
        • Recruiting
        • Grampians Health
        • Contact:
          • LeeNa Teo, Site 0197
          • Phone Number: +61409338111
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health
        • Contact:
          • Belinda Yeo, Site 0031
          • Phone Number: 0450737873
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
          • Peter Savas, Site 0274
          • Phone Number: +61402147682
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • Recruiting
        • St. John of God Subiaco Hospital
        • Contact:
          • Daphne Tsoi, Site 0028
          • Phone Number: 61864659200
  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Uniklinikum Salzburg
        • Contact:
          • Simon Gampenrieder, Site 0267
          • Phone Number: 435725558858
      • Sankt Pölten, Austria, 3100
        • Recruiting
        • Universitätsklinikum St. Pölten
        • Contact:
          • Maria Gold, Site 0270
          • Phone Number: 00432742900422175
      • Vienna, Austria, 1090
        • Recruiting
        • Medizinische Universität Wien
        • Contact:
          • Rupert Bartsch, Site 0269
          • Phone Number: 43140400444500
    • Styria
      • Graz, Styria, Austria, 8036
        • Recruiting
        • Medizinische Universität Graz
        • Contact:
          • Vassiliki Kolovetsiou Kreiner, Site 0292
          • Phone Number: 4331638580643
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Recruiting
        • Medizinische Universitaet Innsbruck
        • Contact:
          • Daniel Egle, Site 0268
          • Phone Number: 004351250481503
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Recruiting
        • Instituto Nacional de Cancer - INCa
        • Contact:
          • Susanne Crocamo V Da Costa, Site 0153
          • Phone Number: 552125774242
      • São Paulo, Brazil, 01317-000
        • Recruiting
        • Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
        • Contact:
          • Roberto Hegg, Site 0144
          • Phone Number: 5511991931500
      • São Paulo, Brazil, 01401-002
        • Recruiting
        • Instituto D'Or de Pesquisa e Ensino (IDOR)
        • Contact:
          • Renata Bonadio, Site 0149
          • Phone Number: +5511989554040
    • Amazonas
      • Manaus, Amazonas, Brazil, 69020-030
        • Withdrawn
        • Local Institution - 0187
    • Ceará
      • Fortaleza, Ceará, Brazil, 60135-237
        • Recruiting
        • Oncocentro Oncologia
        • Contact:
          • Roberto Furlani, Site 0147
          • Phone Number: +5585999211461
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055450
        • Recruiting
        • CEDOES
        • Contact:
          • Mauricio Pereira, Site 0157
          • Phone Number: +5521998795727
    • Paraná
      • Curitiba, Paraná, Brazil, 81480-580
        • Recruiting
        • Centro Integrado de Oncologia de Curitiba
        • Contact:
          • Karina Vianna, Site 0159
          • Phone Number: +554130242421
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90470-340
        • Recruiting
        • Futtura Oncology - Clinical Research Hub
        • Contact:
          • Gustavo Werutsky, Site 0199
          • Phone Number: 51995868013
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784400
        • Recruiting
        • Fundação Pio XII - Hospital de Câncer de Barretos
        • Contact:
          • Karina Oikawa, Site 0148
          • Phone Number: 1733216600
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Not yet recruiting
        • Local Institution - 0164
        • Contact:
          • Site 0164
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Recruiting
        • BC Cancer Kelowna
        • Contact:
          • Susan Ellard, Site 0218
          • Phone Number: +1250-712-3996
      • Victoria, British Columbia, Canada, V8R 6V5
        • Not yet recruiting
        • Local Institution - 0217
        • Contact:
          • Site 0217
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital - General Campus
        • Contact:
          • Xinni Song, Site 0265
          • Phone Number: 6137377700ext70208
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
        • Contact:
          • Jamil Asselah, Site 0219
          • Phone Number: 514934193435721
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal
        • Contact:
          • Danielle Charpentier, Site 0215
          • Phone Number: 5148908000
      • Saint-Charles-Borromée, Quebec, Canada, J6E 6J2
        • Recruiting
        • Centre Intégré de Santé et de Services Sociaux de Lanaudière
        • Contact:
          • Angélique Brunot, Site 0350
          • Phone Number: 579-593-1172
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS
        • Contact:
          • Michel Pavic, Site 0216
          • Phone Number: 819-346-1110x74816
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Recruiting
        • Bradfordhill
        • Contact:
          • Carlos Gallardo, Site 0018
          • Phone Number: +56978878489
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Recruiting
        • FALP
        • Contact:
          • Felipe Reyes, Site 0138
          • Phone Number: 56975798360
      • Santiago, Santiago Metropolitan, Chile, 8330032
        • Recruiting
        • Pontificia Universidad Catolica de Chile
        • Contact:
          • Cesar Sanchez, Site 0017
          • Phone Number: 56223546919
      • Santiago, Santiago Metropolitan, Chile, 7650568
        • Recruiting
        • Clínica Alemana de Santiago
        • Contact:
          • Jose Sola, Site 0021
          • Phone Number: +56994016361
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • Oncocentro APYS
        • Contact:
          • Alejandro Acevedo Gaete, Site 0016
          • Phone Number: +56992369820
  • China
      • Guangzhou, China, 510060
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:
          • Shusen Wang, Site 1025
          • Phone Number: 8613926168469
    • Anhui
      • Hefei, Anhui, China, 230001
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:
          • Nannan Lu, Site 1002
          • Phone Number: 8618130056850
      • Hefei, Anhui, China, 230601
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
          • Fanfan Li, Site 1003
          • Phone Number: +8613855137365
    • BEI
      • Beijing, BEI, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
          • Binghe Xu, Site 1001
          • Phone Number: +86 13501028690
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Huiping Li, Site 1005
          • Phone Number: 8613811012595
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Donggui Wan, Site 1024
          • Phone Number: 8619854715414
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Fan Wu, Site 1006
          • Phone Number: 8613859082118
      • Fyzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • Fangmeng Fu, Site 1007
          • Phone Number: 8613365917923
      • Xiamen, Fujian, China, 361003
        • Not yet recruiting
        • Local Institution - 1016
        • Contact:
          • Site 1016
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
          • Xiaoling Ling, Site 1031
          • Phone Number: 8618693165668
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Guangxi Medical University Affiliated Cancer Hospital
        • Contact:
          • Wei Wei, Site 1008
          • Phone Number: 8618577071966
    • HUN
      • Changsha, HUN, China, 410013
        • Not yet recruiting
        • Local Institution - 1011
        • Contact:
          • Site 1011
    • Harbin
      • Harbin, Harbin, China, 150001
        • Recruiting
        • The First Hospital of harbin University
        • Contact:
          • Li Cai, Site 1028
          • Phone Number: 8613313602929
    • Henan
      • Anyang, Henan, China, 455110
        • Recruiting
        • Anyang Cancer Hospital
        • Contact:
          • Junlan Guo, Site 1004
          • Phone Number: 8615037272967
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Min Yan, Site 1009
          • Phone Number: 8615713857388
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Wei He, Site 1032
          • Phone Number: +8618638553286
    • Hubei
      • Wuhan, Hubei, China, 430070
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
          • Xinhong Wu, Site 1010
          • Phone Number: 8618602726300
      • Wuhan, Hubei, China, 430061
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • Haijun Yu, Site 1021
          • Phone Number: 8613971665181
      • Xiangyang, Hubei, China, 441000
        • Recruiting
        • Xiangyang Central Hospital
        • Contact:
          • Yuehua Wang, Site 1022
          • Phone Number: 8613995777482
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
          • Zhengkui Sun, Site 1013
          • Phone Number: 8613907000210
    • Liaoning
      • Changchun, Liaoning, China, 130021
        • Not yet recruiting
        • Local Institution - 1012
        • Contact:
          • Site 1012
      • Shenyang, Liaoning, China, 140001
        • Not yet recruiting
        • Local Institution - 1014
        • Contact:
          • Site 1014
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Cancer Hospital of Shandong First Medical University
        • Contact:
          • Huihui Li, Site 1017
          • Phone Number: 8615553103209
      • Qingdao, Shandong, China, 266071
        • Recruiting
        • The affiliated hospital of Qingdao university
        • Contact:
          • Haibo Wang, Site 1015
          • Phone Number: 8618661805787
    • Shanxi
      • Taiyuan, Shanxi, China, 650118
        • Recruiting
        • Shanxi Cancer Hospital
        • Contact:
          • Guohui Han, Site 1018
          • Phone Number: 8613454858188
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Jing Luo, Site 1019
          • Phone Number: 8618981838521
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Cancer hospital Airport hospital
        • Contact:
          • Chunfang Hao, Site 1027
          • Phone Number: 8613602031629
      • Tianjin, Tianjin Municipality, China, 301000
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Yedong Shi, Site 1020
          • Phone Number: 8618622221183
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Recruiting
        • Yunnan Cancer Hospital
        • Contact:
          • Guojun Zhang, Site 1029
          • Phone Number: 8618850064298
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310024
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Peifen Fu, Site 1023
          • Phone Number: 8613958161556
  • Colombia
      • Medellín, Colombia, 050030
        • Not yet recruiting
        • Local Institution - 0349
        • Contact:
          • Site 0349
    • Antioquia
      • Medellín, Antioquia, Colombia, 50021
        • Withdrawn
        • Local Institution - 0195
      • Rionegro, Antioquia, Colombia, 054047
        • Not yet recruiting
        • Local Institution - 0201
        • Contact:
          • Site 0201
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080020
        • Not yet recruiting
        • Local Institution - 0194
        • Contact:
          • Site 0194
      • Puerto Colombia, Atlántico, Colombia, 81001
        • Withdrawn
        • Local Institution - 0182
    • COR
      • Montería, COR, Colombia, 230002
        • Not yet recruiting
        • Local Institution - 0181
        • Contact:
          • Site 0181
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 111151
        • Not yet recruiting
        • Local Institution - 0327
        • Contact:
          • Site 0327
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Not yet recruiting
        • Local Institution - 0183
        • Contact:
          • Site 0183
  • France
      • Lille, France, 59000
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
          • Nawale Hajjaji, Site 0094
          • Phone Number: +33247478261
      • Paris, France, 75248
        • Withdrawn
        • Local Institution - 0088
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Recruiting
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
        • Contact:
          • Celine Blaye, Site 0089
          • Phone Number: 555-555-5555
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69008
        • Not yet recruiting
        • Local Institution - 0090
        • Contact:
          • Site 0090
    • Côte-d'Or
      • Dijon, Côte-d'Or, France, 21079
        • Recruiting
        • Centre Georges François Leclerc
        • Contact:
          • Sylvain Ladoire, Site 0272
          • Phone Number: 33380737506
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Withdrawn
        • Local Institution - 0098
    • Hérault
      • Montpellier, Hérault, France, 34298
        • Recruiting
        • Institut Régional du Cancer Montpellier
        • Contact:
          • Marie Alexandre, Site 0095
          • Phone Number: 33467612393
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35042
        • Recruiting
        • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer
        • Contact:
          • Perrine VUAGNAT, Site 0099
          • Phone Number: 3362299252969
    • Loire-Atlantique
      • Saint-Herblain, Loire-Atlantique, France, 44805
        • Recruiting
        • Institut de Cancérologie de l'Ouest
        • Contact:
          • Mario Campone, Site 0092
          • Phone Number: 33240679977
    • Marne
      • Reims, Marne, France, 51726
        • Withdrawn
        • Local Institution - 0091
    • Paris
      • Villejuif, Paris, France, 94800
        • Recruiting
        • Gustave Roussy
        • Contact:
          • Thomas Grinda, Site 0097
          • Phone Number: 0142114211
    • Provence-Alpes-Côte d'Azur Region
      • Marseille, Provence-Alpes-Côte d'Azur Region, France, 13273
        • Recruiting
        • Institut Paoli-Calmettes
        • Contact:
          • Alexandre Tassin de Nonneville, Site 0093
          • Phone Number: 0033621713044
    • Puy-de-Dôme
      • Clermont-Ferrand, Puy-de-Dôme, France, 63011
        • Recruiting
        • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
        • Contact:
          • Marie-Ange Mouret-Reynier, Site 0096
          • Phone Number: 33473278005
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Not yet recruiting
        • Local Institution - 1033
        • Contact:
          • Site 1033
  • Germany
      • Berlin, Germany, 10967
        • Recruiting
        • Vivantes Klinikum am Urban
        • Contact:
          • Christian Scholz, Site 0260
          • Phone Number: 004930130222100
      • Berlin, Germany, 10117
        • Recruiting
        • Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
        • Contact:
          • Caroline Neeb, Site 0261
          • Phone Number: +4930450664484
      • Bonn, Germany, 53111
        • Recruiting
        • Gynaekologisches Zentrum Bonn
        • Contact:
          • Christian Kurbacher, Site 0259
          • Phone Number: +4922890927671
      • Dresden, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden
        • Contact:
          • Theresa Link, Site 0258
          • Phone Number: 4935145818084
      • Heidelberg, Germany, D-69120
        • Recruiting
        • Universitaetsklinikum Heidelberg
        • Contact:
          • Carlo Fremd, Site 0262
          • Phone Number: 004962215634970
      • Ulm, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm
        • Contact:
          • Sabine Heublein, Site 0291
          • Phone Number: +4973150058523
    • Baden-Wurttemberg
      • Esslingen am Neckar, Baden-Wurttemberg, Germany, 73730
        • Recruiting
        • Klinikum Esslingen
        • Contact:
          • Alexander Hein, Site 0320
          • Phone Number: +4971131033051
    • Bavaria
      • Augsburg, Bavaria, Germany, 86156
        • Recruiting
        • Klinikum Augsburg
        • Contact:
          • Nina Ditsch, Site 0256
          • Phone Number: 00498214002208
      • München, Bavaria, Germany, 80637
        • Recruiting
        • Rotkreuzklinikum München gemeinnützige GmbH
        • Contact:
          • Michael Braun, Site 0271
          • Phone Number: 00498913033797
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Recruiting
        • Universitätsklinikum Frankfurt Goethe-Universität
        • Contact:
          • Christine Solbach, Site 0306
          • Phone Number: +4916096965363
      • Langen, Hesse, Germany, 63225
        • Recruiting
        • Gemeinschaftspraxis für Hämatologie und Onkologie
        • Contact:
          • Andreas Köhler, Site 0333
          • Phone Number: +4961033018276
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
          • Tjoung-Won Park-Simon, Site 0257
          • Phone Number: 495115329545
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40235
        • Completed
        • Local Institution - 0293
      • Essen, North Rhine-Westphalia, Germany, 45136
        • Recruiting
        • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
        • Contact:
          • Jennifer Spoenlein, Site 0263
          • Phone Number: 020117433092
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Not yet recruiting
        • Local Institution - 0254
        • Contact:
          • Site 0254
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein
        • Contact:
          • Maggie Banys-Paluchowski, Site 0255
          • Phone Number: 004945150041700
  • Greece
    • Attikí
      • Athens, Attikí, Greece, 115 22
        • Recruiting
        • Agios Savvas Regional Cancer Hospital
        • Contact:
          • Dimitrios Tryfonopoulos, Site 0042
          • Phone Number: +306932669110
      • Athens, Attikí, Greece, 185 47
        • Not yet recruiting
        • Local Institution - 0038
        • Contact:
          • Site 0038
    • Attikí (Region)
      • Athens, Attikí (Region), Greece, 115 28
        • Not yet recruiting
        • Local Institution - 0043
        • Contact:
          • Site 0043
    • Irakleío
      • Heraklion, Irakleío, Greece, 715 00
        • Recruiting
        • University General Hospital of Heraklion
        • Contact:
          • Dimitrios Mavroudis, Site 0086
          • Phone Number: 302810392750
  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Not yet recruiting
        • Local Institution - 0131
        • Contact:
          • Site 0131
      • Mumbai, Maharashtra, India, 400 057
        • Withdrawn
        • Local Institution - 0337
      • Nagpur, Maharashtra, India, 440001
        • Not yet recruiting
        • Local Institution - 0134
        • Contact:
          • Site 0134
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Not yet recruiting
        • Local Institution - 0266
        • Contact:
          • Site 0266
      • New Delhi, National Capital Territory of Delhi, India, 110085
        • Not yet recruiting
        • Local Institution - 0206
        • Contact:
          • Site 0206
      • New Delhi, National Capital Territory of Delhi, India, 110017
        • Withdrawn
        • Local Institution - 0352
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600035
        • Not yet recruiting
        • Local Institution - 0125
        • Contact:
          • Site 0125
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Not yet recruiting
        • Local Institution - 0130
        • Contact:
          • Site 0130
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221005
        • Not yet recruiting
        • Local Institution - 0133
        • Contact:
          • Site 0133
  • Israel
    • Central District
      • Petah Tikva, Central District, Israel, 4941492
        • Not yet recruiting
        • Local Institution - 0186
        • Contact:
          • Site 0186
      • Ramat Gan, Central District, Israel, 5265601
        • Recruiting
        • Sheba Medical Center
        • Contact:
          • Einav Nili-Gal-Yam, Site 0044
          • Phone Number: 972-3-5304961
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
        • Contact:
          • Shani Paluch-Shimon, Site 0047
          • Phone Number: 972542626027
    • Northern District
      • Hadera, Northern District, Israel, 38100
        • Recruiting
        • Hillel Yaffe Medical Center
        • Contact:
          • Salome Khutsurauli, Site 0048
          • Phone Number: 972528730448
      • Haifa, Northern District, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
        • Contact:
          • Ayelet Shai, Site 0123
          • Phone Number: 972-4-777-6700
  • Italy
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia IRCCS
        • Contact:
          • Giuseppe Curigliano, Site 0052
          • Phone Number: 390257490439
      • Naples, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II
        • Contact:
          • Grazia Arpino, Site 0058
          • Phone Number: 390817463660
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore della Carità
        • Contact:
          • Alessandra Gennari, Site 0061
          • Phone Number: 03213733822
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS
        • Contact:
          • Valentina Guarneri, Site 0056
          • Phone Number: 00390498215931
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
        • Contact:
          • Alessandra Fabi, Site 0062
          • Phone Number: 00390630157983
    • Campania
      • Naples, Campania, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
        • Contact:
          • Michelino De Laurentiis, Site 0051
          • Phone Number: +3908117770442
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
        • Contact:
          • Claudio Zamagni, Site 0049
          • Phone Number: +390512144548
    • Friuli Venezia Giulia
      • Aviano, Friuli Venezia Giulia, Italy, 33081
        • Recruiting
        • Cro-Irccs
        • Contact:
          • Fabio Puglisi, Site 0057
          • Phone Number: +393663239989
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • Recruiting
        • Ospedale San Martino
        • Contact:
          • Lucia Del Mastro, Site 0054
          • Phone Number: 390105558908
    • Pisa
      • Pontedera, Pisa, Italy, 56025
        • Recruiting
        • Ospedale "Felice Lotti" Di Pontedera
        • Contact:
          • Luigi Coltelli, Site 0053
          • Phone Number: 0586223416
    • Tuscany
      • Prato, Tuscany, Italy, 59100
        • Recruiting
        • Nuovo Ospedale di Prato-S.Stefano
        • Contact:
          • Laura Biganzoli, Site 0055
          • Phone Number: 390574802532
  • Japan
      • Fukuoka, Japan, 811-1395
        • Not yet recruiting
        • Local Institution - 0242
        • Contact:
          • Site 0242
      • Fukushima, Japan, 960-1295
        • Not yet recruiting
        • Local Institution - 0225
        • Contact:
          • Site 0225
      • Hiroshima, Japan, 7308518
        • Not yet recruiting
        • Local Institution - 0243
        • Contact:
          • Site 0243
      • Kagoshima, Japan, 892-0833
        • Not yet recruiting
        • Local Institution - 0244
        • Contact:
          • Site 0244
      • Kyoto, Japan, 606-8507
        • Not yet recruiting
        • Local Institution - 0235
        • Contact:
          • Site 0235
      • Okayama, Japan, 700-8558
        • Not yet recruiting
        • Local Institution - 0241
        • Contact:
          • Site 0241
      • Osaka, Japan, 541-8567
        • Not yet recruiting
        • Local Institution - 0239
        • Contact:
          • Site 0239
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Not yet recruiting
        • Local Institution - 0236
        • Contact:
          • Site 0236
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Not yet recruiting
        • Local Institution - 0230
        • Contact:
          • Site 0230
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Not yet recruiting
        • Local Institution - 0240
        • Contact:
          • Site 0240
    • Gunma
      • Otashi, Gunma, Japan, 373-8550
        • Not yet recruiting
        • Local Institution - 0226
        • Contact:
          • Site 0226
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • Not yet recruiting
        • Local Institution - 0222
        • Contact:
          • Site 0222
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8530
        • Not yet recruiting
        • Local Institution - 0232
        • Contact:
          • Site 0232
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Not yet recruiting
        • Local Institution - 0234
        • Contact:
          • Site 0234
      • Yokohama, Kanagawa, Japan, 2418515
        • Not yet recruiting
        • Local Institution - 0237
        • Contact:
          • Site 0237
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Not yet recruiting
        • Local Institution - 0246
        • Contact:
          • Site 0246
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Not yet recruiting
        • Local Institution - 0223
        • Contact:
          • Site 0223
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Not yet recruiting
        • Local Institution - 0238
        • Contact:
          • Site 0238
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Not yet recruiting
        • Local Institution - 0227
        • Contact:
          • Site 0227
      • Ina-machi, Saitama, Japan, 362-0806
        • Not yet recruiting
        • Local Institution - 0224
        • Contact:
          • Site 0224
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Not yet recruiting
        • Local Institution - 0231
        • Contact:
          • Site 0231
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Not yet recruiting
        • Local Institution - 0229
        • Contact:
          • Site 0229
      • Koto, Tokyo, Japan, 135-8550
        • Not yet recruiting
        • Local Institution - 0228
        • Contact:
          • Site 0228
      • Shinagawa, Tokyo, Japan, 142-8666
        • Not yet recruiting
        • Local Institution - 0245
        • Contact:
          • Site 0245
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Not yet recruiting
        • Local Institution - 0233
        • Contact:
          • Site 0233
  • Mexico
      • Chihuahua City, Mexico, 31207
        • Not yet recruiting
        • Local Institution - 0174
        • Contact:
          • Site 0174
    • DIF
      • Mexico City, DIF, Mexico, 03100
        • Not yet recruiting
        • Local Institution - 0177
        • Contact:
          • Site 0177
    • Estado de Baja California
      • Tijuana, Estado de Baja California, Mexico, 22010
        • Not yet recruiting
        • Local Institution - 0264
        • Contact:
          • Site 0264
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44680
        • Not yet recruiting
        • Local Institution - 0178
        • Contact:
          • Site 0178
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14070
        • Not yet recruiting
        • Local Institution - 0329
        • Contact:
          • Site 0329
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64320
        • Not yet recruiting
        • Local Institution - 0175
        • Contact:
          • Site 0175
      • Monterrey, Nuevo León, Mexico, 64460
        • Not yet recruiting
        • Local Institution - 0176
        • Contact:
          • Site 0176
      • Monterrey, Nuevo León, Mexico, 64460
        • Withdrawn
        • Local Institution - 0355
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Not yet recruiting
        • Local Institution - 0173
        • Contact:
          • Site 0173
    • Yucatán
      • Mérida, Yucatán, Mexico, 97000
        • Not yet recruiting
        • Local Institution - 0179
        • Contact:
          • Site 0179
  • Poland
    • Greater Poland Voivodeship
      • Skórzewo, Greater Poland Voivodeship, Poland, 60-185
        • Recruiting
        • AIDPORT Sp. z o.o.
        • Contact:
          • Renata Szoszkiewicz, Site 0189
          • Phone Number: +48696446632
    • Lublin Voivodeship
      • Biała Podlaska, Lublin Voivodeship, Poland, 21-500
        • Withdrawn
        • Local Institution - 0074
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Not yet recruiting
        • Local Institution - 0072
        • Contact:
          • Site 0072
      • Warsaw, Masovian Voivodeship, Poland, 03-411
        • Recruiting
        • Mazowiecki Szpital Onkologiczny
        • Contact:
          • Michal Kunkiel, Site 0220
          • Phone Number: 48606655734
    • Opole Voivodeship
      • Opole, Opole Voivodeship, Poland, 45-061
        • Not yet recruiting
        • Local Institution - 0076
        • Contact:
          • Site 0076
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-338
        • Recruiting
        • Instytut Centrum Zdrowia Matki Polki
        • Contact:
          • Ewa Kalinka, Site 0221
          • Phone Number: +48530770073
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • Instituto Portugês de Oncologia de Coimbra Francisco Gentil
        • Contact:
          • Gabriela Sousa, Site 0124
          • Phone Number: +351239400200
      • Lisbon, Portugal, 1500-650
        • Recruiting
        • Hospital da Luz Lisboa
        • Contact:
          • Catarina Pulido, Site 0141
          • Phone Number: +351917187738
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
        • Contact:
          • Cristina Oliveira, Site 0111
      • Porto, Portugal, 4200-319
        • Recruiting
        • Centro Hospitalar de Sao Joao - Hospital de Sao Joao
        • Contact:
          • Isabel Augusto, Site 0253
          • Phone Number: +351963903409
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1649-035
        • Recruiting
        • Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
        • Contact:
          • Luis Costa, Site 0109
          • Phone Number: 351217805257
      • Lisbon, Lisbon District, Portugal, 1099-023
        • Recruiting
        • Instituto Portugues de Oncologia de Lisboa Francisco Gentil
        • Contact:
          • Patricia Pereira, Site 0198
      • Lisbon, Lisbon District, Portugal, 1400-038
        • Not yet recruiting
        • Local Institution - 0106
        • Contact:
          • Site 0106
  • Romania
      • Bucharest, Romania, 011171
        • Recruiting
        • Spitalul Clinic Filantropia
        • Contact:
          • Mircea Median, Site 0083
          • Phone Number: 40744874350
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Institutul Oncologic Cluj
        • Contact:
          • Nicoleta Antone, Site 0077
          • Phone Number: 40740226786
      • Dumbrăviţa, Romania, 307160
        • Recruiting
        • Centrul de Radioterapie Amethyst Timis
        • Contact:
          • Elena Boscuta, Site 0211
          • Phone Number: 40784019019
      • Iași, Romania, 700106
        • Recruiting
        • S.C. Centrul de Oncologie Euroclinic S.R.L.
        • Contact:
          • Simona Volovat, Site 0081
          • Phone Number: 0040742024148
      • Iași, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie
        • Contact:
          • Eva Maria Cojocaru, Site 0080
          • Phone Number: +40740030860
      • Ploieşti, Romania, 100337
        • Recruiting
        • Spitalul Municipal Schuller Ploiești
        • Contact:
          • Pompilia Motatu, Site 0084
          • Phone Number: +40723943507
    • Bistrița-Năsăud County
      • Bistriţa, Bistrița-Năsăud County, Romania, 420020
        • Not yet recruiting
        • Local Institution - 0212
        • Contact:
          • Site 0212
    • Bucharest
      • Bucharest, Bucharest, Romania, 012292
        • Not yet recruiting
        • Local Institution - 0213
        • Contact:
          • Site 0213
    • Cluj
      • Florești, Cluj, Romania, 407280
        • Recruiting
        • SC Radiotherapy Center Cluj SRL
        • Contact:
          • Andrei Ungureanu, Site 0079
          • Phone Number: 40742206212
    • Dolj
      • Craiova, Dolj, Romania, 200746
        • Recruiting
        • Centrul de Oncologie "Sfântul Nectarie"
        • Contact:
          • Michael Schenker, Site 0078
          • Phone Number: 40727774974
    • Timiș County
      • Timișoara, Timiș County, Romania, 300239
        • Recruiting
        • Oncohelp Medical Center
        • Contact:
          • Cristina Oprean, Site 0085
          • Phone Number: +40745148485
  • South Africa
      • Johannesburg, South Africa, 2193
        • Not yet recruiting
        • Local Institution - 0342
        • Contact:
          • Site 0342
      • Pretoria, South Africa, 0001
        • Not yet recruiting
        • Local Institution - 0336
        • Contact:
          • Site 0336
      • Pretoria, South Africa, 0084
        • Not yet recruiting
        • Local Institution - 0341
        • Contact:
          • Site 0341
      • Soweto, South Africa, 2013
        • Not yet recruiting
        • Local Institution - 0340
        • Contact:
          • Site 0340
    • Eastern Cape
      • East London, Eastern Cape, South Africa, 5241
        • Not yet recruiting
        • Local Institution - 0351
        • Contact:
          • Site 0351
    • Western Cape
      • Panorama, Western Cape, South Africa, 7500
        • Not yet recruiting
        • Local Institution - 1034
        • Contact:
          • Site 1034
  • South Korea
    • Kyǒnggi-do
      • Goyang-si, Kyǒnggi-do, South Korea, 10408
        • Not yet recruiting
        • Local Institution - 0066
        • Contact:
          • Site 0066
      • Seongnam, Kyǒnggi-do, South Korea, 13620
        • Not yet recruiting
        • Local Institution - 0067
        • Contact:
          • Site 0067
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 02841
        • Not yet recruiting
        • Local Institution - 0068
        • Contact:
          • Site 0068
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
        • Not yet recruiting
        • Local Institution - 0063
        • Contact:
          • Site 0063
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
        • Not yet recruiting
        • Local Institution - 0071
        • Contact:
          • Site 0071
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
        • Not yet recruiting
        • Local Institution - 0064
        • Contact:
          • Site 0064
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Not yet recruiting
        • Local Institution - 0065
        • Contact:
          • Site 0065
    • Taegu-Kwangyǒkshi
      • Daegu, Taegu-Kwangyǒkshi, South Korea, 41404
        • Not yet recruiting
        • Local Institution - 0069
        • Contact:
          • Site 0069
  • Spain
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital Beata María Ana
        • Contact:
          • Javier Cortes Castán, Site 0107
          • Phone Number: 34911175021
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Luis de la Cruz Merino, Site 0103
          • Phone Number: +34955926578
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spain, 15006
        • Recruiting
        • CHUAC-Hospital Teresa Herrera
        • Contact:
          • Silvia Antolin Novoa, Site 0105
          • Phone Number: +34981178000
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Recruiting
        • Hospital General Universitario de Elche
        • Contact:
          • Álvaro Rodríguez-Lescure, Site 0100
          • Phone Number: 111-111-1111
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Ana Mafalda Antunes de Melo e Oliveira, Site 0102
          • Phone Number: 34934894158
      • Hospitalet, Barcelona [Barcelona], Spain, 08907
        • Not yet recruiting
        • Local Institution - 0172
        • Contact:
          • Site 0172
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
          • Marta González Rodríguez, Site 0140
          • Phone Number: +34606895621
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
        • Recruiting
        • Hospital Universitario Donostia
        • Contact:
          • Isabel Alvarez Lopez, Site 0139
          • Phone Number: 34943006002
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Eva María Ciruelos Gil, Site 0108
          • Phone Number: 34913908000
      • Madrid, Madrid, Comunidad de, Spain, 28009
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
          • Sara Lopez Tarruella, Site 0104
          • Phone Number: 34914269392
    • Málaga
      • Málaga, Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Maria Emilia Dominguez Recio, Site 0101
          • Phone Number: 34951291425
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Recruiting
        • Hospital Clinico de Valencia
        • Contact:
          • Begona Bermejo de las Heras, Site 0210
          • Phone Number: 34961973583
  • Sweden
    • Skåne Län [se-12]
      • Malmö, Skåne Län [se-12], Sweden, 205 02
        • Recruiting
        • Skånes Universitetssjukhus Malmö
        • Contact:
          • Ulrik Narbe, Site 0252
          • Phone Number: +4646-175371
    • Stockholms Län [se-01]
      • Stockholm, Stockholms Län [se-01], Sweden, 112 19
        • Recruiting
        • Capio Saint Görans Sjukhus
        • Contact:
          • Luisa Edman Kessler, Site 0026
          • Phone Number: +46858701000
    • Uppsala Län [se-03]
      • Uppsala, Uppsala Län [se-03], Sweden, 751 85
        • Recruiting
        • Akademiska Sjukhuset
        • Contact:
          • Henrik Lindman, Site 0025
          • Phone Number: 46186110000
    • Örebro Län [se-18]
      • Örebro, Örebro Län [se-18], Sweden, 701 85
        • Recruiting
        • Universitetssjukhuset Örebro
        • Contact:
          • Antonios Valachis, Site 0024
          • Phone Number: 0046735617691
    • Östergötlands Län [se-05]
      • Linköping, Östergötlands Län [se-05], Sweden, 581 85
        • Recruiting
        • Universitetssjukhuset i Linköping
        • Contact:
          • Ahmed Albu -Kareem, Site 0247
          • Phone Number: 46101032013
  • Switzerland
      • Zurich, Switzerland, 8008
        • Recruiting
        • Brust-Zentrum
        • Contact:
          • Elena Kralidis, Site 0251
          • Phone Number: 41445338132
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Recruiting
        • Cantonal Hospital St.Gallen
        • Contact:
          • Jens Huober, Site 0250
          • Phone Number: 0714941880
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Switzerland, 1011
        • Recruiting
        • CHUV (centre hospitalier universitaire vaudois)
        • Contact:
          • Athina Stravodimou, Site 0249
          • Phone Number: 0041795564117
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01123
        • Not yet recruiting
        • Local Institution - 0361
        • Contact:
          • Site 0361
      • Ankara, Turkey (Türkiye), 06800
        • Not yet recruiting
        • Local Institution - 0362
        • Contact:
          • Site 0362
      • Istanbul, Turkey (Türkiye), 34722
        • Not yet recruiting
        • Local Institution - 0363
        • Contact:
          • Site 0363
      • Istanbul, Turkey (Türkiye), 34010
        • Not yet recruiting
        • Local Institution - 0364
        • Contact:
          • Site 0364
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Not yet recruiting
        • Local Institution - 0319
        • Contact:
          • Site 0319
    • Abu Dhabi Emirate
      • Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 11001
        • Not yet recruiting
        • Local Institution - 0323
        • Contact:
          • Site 0323
      • Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 92510
        • Not yet recruiting
        • Local Institution - 0318
        • Contact:
          • Site 0318
      • Al Ain City, Abu Dhabi Emirate, United Arab Emirates, 15258
        • Not yet recruiting
        • Local Institution - 0322
        • Contact:
          • Site 0322
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Not yet recruiting
        • Local Institution - 0171
        • Contact:
          • Site 0171
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
        • Contact:
          • Anne Armstrong, Site 0001
          • Phone Number: 01614463746
      • Nottingham, United Kingdom, NG5 1PB
        • Not yet recruiting
        • Local Institution - 0006
        • Contact:
          • Site 0006
    • England
      • Truro, England, United Kingdom, TR1 3LJ
        • Recruiting
        • The Royal Cornwall Hospital
        • Contact:
          • Alastair Thomson, Site 0208
          • Phone Number: 01872258343
    • London, City of
      • London, London, City of, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's & St Thomas' NHS Foundation Trust
        • Contact:
          • Mark Harries, Site 0209
          • Phone Number: 447710238686
      • London, London, City of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew's Hospital
        • Contact:
          • Peter Schmid, Site 0004
          • Phone Number: 442078828498
      • London, London, City of, United Kingdom, SE1 9RT
        • Withdrawn
        • Local Institution - 0204
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Not yet recruiting
        • Local Institution - 0303
        • Contact:
          • Site 0303
    • California
      • Cerritos, California, United States, 90703
        • Withdrawn
        • Local Institution - 0307
      • Cerritos, California, United States, 90703
        • Withdrawn
        • Local Institution - 0308
      • Cerritos, California, United States, 90703
        • Withdrawn
        • Local Institution - 0309
      • Cerritos, California, United States, 90703
        • Recruiting
        • Helios Clinical Research
        • Contact:
          • Omkar Marathe, Site 0328
          • Phone Number: 562-693-4477
      • Long Beach, California, United States, 90805
        • Withdrawn
        • Local Institution - 0311
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC/Norris Comprehensive Cancer Center
        • Contact:
          • Daphne Stewart, Site 0290
          • Phone Number: 323-865-3906
      • Los Angeles, California, United States, 90067
        • Recruiting
        • Valkyrie Clinical Trials
        • Contact:
          • David Berz, Site 0283
          • Phone Number: 424-535-1874
      • Newport Beach, California, United States, 92663
        • Recruiting
        • USC Norris Oncology/Hematology-Newport Beach
        • Contact:
          • Daphne Stewart, Site 0353
          • Phone Number: 323-397-5954
      • Stanford, California, United States, 94305
        • Not yet recruiting
        • Local Institution - 0358
        • Contact:
          • Site 0358
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Local Institution - 0289
        • Contact:
          • Site 0289
      • Denver, Colorado, United States, 80220
        • Recruiting
        • Rocky Mountain Cancer Centers
        • Contact:
          • Mabel Mardones, Site 0367
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants, PA
        • Contact:
          • Jamal Misleh, Site 0304
          • Phone Number: 302-366-1200
    • Florida
      • Pembroke Pines, Florida, United States, 33028
        • Not yet recruiting
        • Local Institution - 0296
        • Contact:
          • Site 0296
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital
        • Contact:
          • Amelia Zelnak, Site 0357
          • Phone Number: 770-205-5292
      • Atlanta, Georgia, United States, 30322
        • Completed
        • Local Institution - 0294
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • Local Institution - 0280
        • Contact:
          • Site 0280
      • Chicago, Illinois, United States, 60612
        • Withdrawn
        • Local Institution - 0278
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Contact:
          • James Wade, Site 0275
          • Phone Number: 217-876-6611
      • O'Fallon, Illinois, United States, 62269
        • Withdrawn
        • Local Institution - 0324
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Ochsner Clinic Foundation
        • Contact:
          • Melanie Sheen, Site 0286
          • Phone Number: 504-842-9780
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Not yet recruiting
        • Local Institution - 1035
        • Contact:
          • Site 1035
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Neelima Vidula, Site 0288
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Sara Tolaney, Site 0287
          • Phone Number: 617-632-5743
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Cancer- Detroit (Brigitte Harris Cancer Pavilion)
        • Contact:
          • Rebecca Chacko, Site 0359
          • Phone Number: 313-530-1949
    • Minnesota
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Minnesota Oncology Hematology
        • Contact:
          • Eric Lander, Site 0313
      • Minneapolis, Minnesota, United States, 55455
        • Not yet recruiting
        • Local Institution - 0372
        • Contact:
          • Site 0372
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Cancer Institute
        • Contact:
          • Timothy Pluard, Site 0284
          • Phone Number: 314-747-7992
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Nour Abuhadra, Site 0279
          • Phone Number: 646-888-4451
      • New York, New York, United States, 10016
        • Withdrawn
        • Local Institution - 0312
      • Syracuse, New York, United States, 13210
        • Not yet recruiting
        • Local Institution - 1037
        • Contact:
          • Site 1037
      • Westbury, New York, United States, 11590
        • Recruiting
        • Clinical Research Alliance
        • Contact:
          • Jonathan Goldberg, Site 0295
          • Phone Number: 914-242-2991
      • White Plains, New York, United States, 10601
        • Recruiting
        • White Plains Hospital
        • Contact:
          • Dan Costin, Site 0285
          • Phone Number: 914-849-7630
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Institute
        • Contact:
          • Carey Anders, Site 0276
          • Phone Number: 919-684-0313
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Willamette Valley Cancer Institute
        • Contact:
          • Miho Dougherty, Site 0316
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Health Network
        • Contact:
          • Nicholas Lamparella, Site 0356
          • Phone Number: 610-402-9543
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Abramson Cancer Center of The University of Pennsylvania
        • Contact:
          • Payal Shah, Site 0310
      • Pittsburgh, Pennsylvania, United States, 15213-3403
        • Not yet recruiting
        • Local Institution - 0360
        • Contact:
          • Site 0360
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • St Francis Cancer Center
        • Contact:
          • Stephen Dyar, Site 0281
          • Phone Number: 864-603-6327
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Oncology - Central/South Texas
        • Contact:
          • Alvaro Restrepo, Site 0315
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Texas Oncology - West Texas
        • Contact:
          • Ines Sanchez-Rivera, Site 0368
          • Phone Number: 915-544-6750
      • Flower Mound, Texas, United States, 75028
        • Recruiting
        • Texas Oncology - Northeast Texas
        • Contact:
          • Vibha Thomas, Site 0305
          • Phone Number: 303-925-0700
      • Houston, Texas, United States, 77024-2843
        • Recruiting
        • (USOR) Texas Oncology
        • Contact:
          • Dhatri Kodali, Site 0314
          • Phone Number: 555-555-5555
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours St. Francis Medical Center
        • Contact:
          • William Irvin, Site 0277
      • Roanoke, Virginia, United States, 24014
        • Not yet recruiting
        • Local Institution - 0301
        • Contact:
          • Site 0301
      • Winchester, Virginia, United States, 22601
        • Recruiting
        • Shenandoah Oncology, P.C.
        • Contact:
          • William Houck, Site 0302
          • Phone Number: 540-662-1108

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER < 1%, PgR < 1%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) per ASCO/CAP criteria, based on the most recently analyzed biopsy or other pathology specimen.
  • Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.

  • Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria:

    i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC; ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) Has a severe auto-immune disease or other contraindication.

  • Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.
  • No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).
  • Measurable disease by CT or MRI as per RECIST v1.1.
  • Other protocol-defined Inclusion/Exclusion criteria 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm B
Drug: Carboplatin
Specified dose on specified days
Drug: Paclitaxel
Specified dose on specified days
Drug: Gemcitabine
Specified dose on specified days
Drug: Capecitabine
Specified dose on specified days
Drug: Nab-paclitaxel
Specified dose on specified days
Experimental: Arm A1
Drug: Iza-bren
Specified dose on specified days
Other Names:
  • BMS-986507
  • BL-B01D1
  • Izalontamab brengitecan
Experimental: Arm A2
Drug: Iza-bren
Specified dose on specified days
Other Names:
  • BMS-986507
  • BL-B01D1
  • Izalontamab brengitecan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Approximately 31 months from first participant randomization
Assessed using Response Evaluation Criteriain Solid Tumors version 1.1 (RECIST v1.1) byblinded independent central review (BICR)
Approximately 31 months from first participant randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Approximately up to 57 months from first participant randomization
Approximately up to 57 months from first participant randomization
Recommended Phase 3 Dose (RP3D) of BMS-986507
Time Frame: Approximately 19 months from first participant randomization
Approximately 19 months from first participant randomization
Number of participants with treatment-related Adverse Events (AEs)
Time Frame: Approximately up to 57 months from first participant randomization
Approximately up to 57 months from first participant randomization
Number of participants with laboratory abnormalities
Time Frame: Approximately up to 57 months from first participant randomization
Approximately up to 57 months from first participant randomization
Number of participants with serious AEs (SAEs)
Time Frame: Approximately up to 57 months from first participant randomization
Approximately up to 57 months from first participant randomization
Number of participants with AEs leading to treatment discontinuation, interruption, dose reduction or dose delay
Time Frame: Approximately up to 57 months from first participant randomization
Approximately up to 57 months from first participant randomization
Number of deaths
Time Frame: Approximately up to 57 months from first participant randomization
Approximately up to 57 months from first participant randomization
Objective Response (OR)
Time Frame: Approximately 31 months from first participant randomization
Approximately 31 months from first participant randomization
PFS
Time Frame: Approximately 31 months from first participant randomization
Assessed by Investigator
Approximately 31 months from first participant randomization
Disease control rate (DCR)
Time Frame: Approximately 31 months from first participant randomization
Approximately 31 months from first participant randomization
Duration of Response (DOR)
Time Frame: Approximately 31 months from first participant randomization
Approximately 31 months from first participant randomization
Time to Response (TTR)
Time Frame: Approximately 31 months from first participant randomization
Approximately 31 months from first participant randomization
Time to subsequent treatment (TTST)
Time Frame: Approximately up to 57 months from first participant randomization
Defined as time from randomization to the start of subsequent therapy or death
Approximately up to 57 months from first participant randomization
Progression-free survival after next line of treatment (PFS2)
Time Frame: Approximately up to 57 months from first participant randomization
Defined as the time from randomization to the date of investigator-defined documented disease progression after next line of treatment or death due to any cause, whichever comes first
Approximately up to 57 months from first participant randomization
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame: Approximately up to 57 months from first participant randomization
Approximately up to 57 months from first participant randomization
Change from baseline in EORTC Breast Cancer-specific Quality of Life Questionnaire (QLQ-BR23)
Time Frame: Approximately up to 57 months from first participant randomization
Approximately up to 57 months from first participant randomization
Functional Assessment of Chronic Illness Therapy item GP5 (FACIT GP5) score
Time Frame: Approximately up to 57 months from first participant randomization
Approximately up to 57 months from first participant randomization
Change from baseline in European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)
Time Frame: Approximately up to 57 months from first participant randomization
Approximately up to 57 months from first participant randomization
PFS rate
Time Frame: Approximately 19 months from first participant randomization
Assessed using RECIST v1.1 by BICR
Approximately 19 months from first participant randomization
Relative change in tumor size
Time Frame: Approximately up to 19 months from first participant randomization
Approximately up to 19 months from first participant randomization
ORR by RECIST v1.1 per Investigator
Time Frame: Approximately 31 months from first participant randomization
Approximately 31 months from first participant randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
SystImmune Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA244-0008
  • 2024-519871-24 (Other Identifier: EU CTR)
  • U1111-1316-1533 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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