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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)
Sponsor: Bristol-Myers Squibb
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-09-11
Completion Date
2030-05-15
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Iza-bren
Specified dose on specified days
Nab-paclitaxel
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Capecitabine
Specified dose on specified days
Carboplatin
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Locations (293)
Local Institution - 0303
Hot Springs, Arkansas, United States
Helios Clinical Research
Cerritos, California, United States
Local Institution - 0307
Cerritos, California, United States
Local Institution - 0308
Cerritos, California, United States
Local Institution - 0309
Cerritos, California, United States
Local Institution - 0311
Long Beach, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States
Local Institution - 0358
Stanford, California, United States
Local Institution - 0289
Aurora, Colorado, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, United States
Local Institution - 0296
Pembroke Pines, Florida, United States
Local Institution - 0294
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Local Institution - 0278
Chicago, Illinois, United States
Local Institution - 0280
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Local Institution - 0324
O'Fallon, Illinois, United States
Ochsner Clinic Foundation
Covington, Louisiana, United States
Local Institution - 1035
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Local Institution - 0359
Detroit, Michigan, United States
Minnesota Oncology Hematology
Maple Grove, Minnesota, United States
Local Institution - 0372
Minneapolis, Minnesota, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Local Institution - 0312
New York, New York, United States
Local Institution - 0279
New York, New York, United States
Clinical Research Alliance
Westbury, New York, United States
White Plains Hospital
White Plains, New York, United States
Local Institution - 0276
Durham, North Carolina, United States
Willamette Valley Cancer Institute
Eugene, Oregon, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Local Institution - 0360
Pittsburgh, Pennsylvania, United States
St Francis Cancer Center
Greenville, South Carolina, United States
Texas Oncology - Central/South Texas
Austin, Texas, United States
Texas Oncology - West Texas
El Paso, Texas, United States
Texas Oncology - Northeast Texas
Flower Mound, Texas, United States
(USOR) Texas Oncology
Houston, Texas, United States
Bon Secours St. Francis Medical Center
Midlothian, Virginia, United States
Local Institution - 0301
Roanoke, Virginia, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, United States
Local Institution - 0011
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina
Hospital Italiano de Córdoba
Córdoba, Córdoba Province, Argentina
Centro Privado de RMI Río Cuarto S.A. II
Río Cuarto, Córdoba Province, Argentina
Sanatorio Plaza
Rosario, Santa Fe Province, Argentina
Instituto Argentino de Diagnóstico y Tratamiento (IADT)
Buenos Aires, Argentina
Centro Oncologico Korben
Buenos Aires, Argentina
Instituto Alexander Fleming
Buenos Aires, Argentina
Local Institution - 0346
Buenos Aires, Argentina
Fundación Oncológica Mendoza
Mendoza, Argentina
Macquarie University
Macquarie University, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Grampians Health
Ballarat Central, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
St. John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Medizinische Universität Graz
Graz, Styria, Austria
Medizinische Universitaet Innsbruck
Innsbruck, Tyrol, Austria
Uniklinikum Salzburg
Salzburg, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, Austria
Medizinische Universität Wien
Vienna, Austria
Local Institution - 0187
Manaus, Amazonas, Brazil
Oncocentro Oncologia
Fortaleza, Ceará, Brazil
CEDOES
Vitória, Espírito Santo, Brazil
Centro Integrado de Oncologia de Curitiba
Curitiba, Paraná, Brazil
Futtura Oncology - Clinical Research Hub
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
Local Institution - 0164
São José do Rio Preto, São Paulo, Brazil
Instituto Nacional de Câncer - INCA
Rio de Janeiro, Brazil
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
São Paulo, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, Brazil
BC Cancer Kelowna
Kelowna, British Columbia, Canada
Local Institution - 0217
Victoria, British Columbia, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Centre Intégré de Santé et de Services Sociaux de Lanaudière
Saint-Charles-Borromée, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS
Sherbrooke, Quebec, Canada
Local Institution - 0016
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0138
Santiago, Santiago Metropolitan, Chile
Local Institution - 0021
Santiago, Santiago Metropolitan, Chile
Local Institution - 0017
Santiago, Santiago Metropolitan, Chile
Local Institution - 0018
Santiago, Santiago Metropolitan, Chile
Anhui Provincial Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Local Institution - 1005
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, BEI, China
Local Institution - 1006
Fuzhou, Fujian, China
Fujian Medical University Union Hospital
Fyzhou, Fujian, China
Local Institution - 1016
Xiamen, Fujian, China
Local Institution - 1031
Lanzhou, Gansu, China
Guangxi Medical University Affiliated Cancer Hospital
Nanning, Guangxi, China
Local Institution - 1028
Harbin, Harbin, China
Anyang Cancer Hospital
Anyang, Henan, China
Local Institution - 1009
Zhengzhou, Henan, China
Local Institution - 1032
Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Local Institution - 1011
Changsha, HUN, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Local Institution - 1012
Changchun, Liaoning, China
Local Institution - 1014
Shenyang, Liaoning, China
Local Institution - 1017
Jinan, Shandong, China
Local Institution - 1015
Qingdao, Shandong, China
Local Institution - 1018
Taiyuan, Shanxi, China
Sichuan Provincial People'S Hospital
Chengdu, Sichuan, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
Local Institution - 1020
Tianjin, Tianjin Municipality, China
Local Institution - 1029
Kunming, Yunnan, China
Local Institution - 1023
Hangzhou, Zhejiang, China
Local Institution - 1025
Guangzhou, China
Local Institution - 0195
Medellín, Antioquia, Colombia
Local Institution - 0201
Rionegro, Antioquia, Colombia
Local Institution - 0194
Barranquilla, Atlántico, Colombia
Local Institution - 0182
Puerto Colombia, Atlántico, Colombia
Local Institution - 0181
Montería, COR, Colombia
Local Institution - 0327
Bogota, Cundinamarca, Colombia
Local Institution - 0183
Cali, Valle del Cauca Department, Colombia
Local Institution - 0349
Medellín, Colombia
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine, France
Local Institution - 0090
Lyon, Auvergne-Rhône-Alpes, France
Local Institution - 0272
Dijon, Côte-d'Or, France
Local Institution - 0098
Toulouse, Haute-Garonne, France
Institut Régional du Cancer Montpellier
Montpellier, Hérault, France
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer
Rennes, Ille-et-Vilaine, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire-Atlantique, France
Local Institution - 0091
Reims, Marne, France
Gustave Roussy
Villejuif, Paris, France
Institut Paoli-Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, Puy-de-Dôme, France
Local Institution - 1033
Poitiers, Vienne, France
Centre Oscar Lambret
Lille, France
Local Institution - 0088
Paris, France
Klinikum Esslingen
Esslingen am Neckar, Baden-Wurttemberg, Germany
Klinikum Augsburg
Augsburg, Bavaria, Germany
Rotkreuzklinikum München gemeinnützige GmbH
München, Bavaria, Germany
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt am Main, Hesse, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Langen, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Luisenkrankenhaus Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, North Rhine-Westphalia, Germany
Local Institution - 0254
Leipzig, Saxony, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, Germany
Vivantes Klinikum Am Urban
Berlin, Germany
Gynaekologisches Zentrum Bonn
Bonn, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Universitaetsklinikum Ulm
Ulm, Germany
Local Institution - 0043
Athens, Attikí (Region), Greece
Agios Savvas Regional Cancer Hospital
Athens, Attikí, Greece
Local Institution - 0038
Athens, Attikí, Greece
University General Hospital of Heraklion
Heraklion, Irakleío, Greece
Local Institution - 0337
Mumbai, Maharashtra, India
Local Institution - 0131
Mumbai, Maharashtra, India
Local Institution - 0134
Nagpur, Maharashtra, India
Local Institution - 0352
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0266
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0206
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0125
Chennai, Tamil Nadu, India
Local Institution - 0130
Hyderabad, Telangana, India
Local Institution - 0133
Varanasi, Uttar Pradesh, India
Local Institution - 0186
Petah Tikva, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Hillel Yaffe Medical Center
Hadera, Northern District, Israel
Rambam Health Care Campus
Haifa, Northern District, Israel
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Campania, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, Italy
Cro-Irccs
Aviano, Friuli Venezia Giulia, Italy
Ospedale San Martino
Genoa, Liguria, Italy
Ospedale "Felice Lotti" Di Pontedera
Pontedera, Pisa, Italy
Nuovo Ospedale di Prato-S.Stefano
Prato, Tuscany, Italy
Istituto Europeo di Oncologia IRCCS
Milan, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy
Local Institution - 0056
Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, Italy
Local Institution - 0236
Nagoya, Aichi-ken, Japan
Local Institution - 0230
Chiba, Chiba, Japan
Local Institution - 0240
Matsuyama, Ehime, Japan
Local Institution - 0226
Otashi, Gunma, Japan
Local Institution - 0222
Sapporo, Hokkaido, Japan
Local Institution - 0232
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0234
Isehara, Kanagawa, Japan
Local Institution - 0237
Yokohama, Kanagawa, Japan
Local Institution - 0246
Tsu, Mie-ken, Japan
Local Institution - 0223
Sendai, Miyagi, Japan
Local Institution - 0238
Suita, Osaka, Japan
Local Institution - 0227
Hidaka, Saitama, Japan
Local Institution - 0224
Ina-machi, Saitama, Japan
Local Institution - 0231
Bunkyo-ku, Tokyo, Japan
Local Institution - 0229
Chuo-ku, Tokyo, Japan
Local Institution - 0228
Koto, Tokyo, Japan
Local Institution - 0245
Shinagawa, Tokyo, Japan
Local Institution - 0233
Shinjuku-ku, Tokyo, Japan
Local Institution - 0242
Fukuoka, Japan
Local Institution - 0225
Fukushima, Japan
Local Institution - 0243
Hiroshima, Japan
Local Institution - 0244
Kagoshima, Japan
Local Institution - 0235
Kyoto, Japan
Local Institution - 0241
Okayama, Japan
Local Institution - 0239
Osaka, Japan
Local Institution - 0177
Mexico City, DIF, Mexico
Local Institution - 0264
Tijuana, Estado de Baja California, Mexico
Local Institution - 0178
Guadalajara, Jalisco, Mexico
Local Institution - 0329
Mexico City, Mexico City, Mexico
Local Institution - 0175
Monterrey, Nuevo León, Mexico
Local Institution - 0176
Monterrey, Nuevo León, Mexico
Local Institution - 0355
Monterrey, Nuevo León, Mexico
Local Institution - 0173
Oaxaca City, Oaxaca, Mexico
Local Institution - 0179
Mérida, Yucatán, Mexico
Local Institution - 0174
Chihuahua City, Mexico
AIDPORT Sp. z o.o.
Skórzewo, Greater Poland Voivodeship, Poland
Local Institution - 0074
Biała Podlaska, Lublin Voivodeship, Poland
Local Institution - 0072
Warsaw, Masovian Voivodeship, Poland
Mazowiecki Szpital Onkologiczny
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0076
Opole, Opole Voivodeship, Poland
Local Institution - 0221
Lodz, Łódź Voivodeship, Poland
Instituto Português de Oncologia de Lisboa Francisco Gentil
Lisbon, Lisbon District, Portugal
Local Institution - 0106
Lisbon, Lisbon District, Portugal
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, Lisbon District, Portugal
Instituto Portugês de Oncologia de Coimbra Francisco Gentil
Coimbra, Portugal
Hospital da Luz Lisboa
Lisbon, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal
Centro Hospitalar de Sao Joao - Hospital de Sao Joao
Porto, Portugal
Local Institution - 0212
Bistriţa, Bistrița-Năsăud County, Romania
Local Institution - 0213
Bucharest, București, Romania
SC Radiotherapy Center Cluj SRL
Florești, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, Romania
Cabinet Medical Oncomed
Timișoara, Timiș County, Romania
Spitalul Clinic Filantropia
Bucharest, Romania
Institutul Oncologic Cluj
Cluj-Napoca, Romania
Centrul de Radioterapie Amethyst Timis
Dumbrăviţa, Romania
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași, Romania
Institutul Regional de Oncologie
Iași, Romania
Spitalul Municipal Schuller Ploiești
Ploieşti, Romania
Local Institution - 0351
East London, Eastern Cape, South Africa
Local Institution - 0342
Parktown, Gauteng, South Africa
Local Institution - 0336
Pretoria, Gauteng, South Africa
Local Institution - 0341
Pretoria, Gauteng, South Africa
Local Institution - 0340
Soweto, Gauteng, South Africa
Local Institution - 1034
Panorama, Western Cape, South Africa
Local Institution - 0066
Goyang-si, Kyǒnggi-do, South Korea
Local Institution - 0067
Seongnam, Kyǒnggi-do, South Korea
Local Institution - 0068
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0063
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0071
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0064
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0065
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0069
Daegu, Taegu-Kwangyǒkshi, South Korea
CHUAC-Hospital Teresa Herrera
A Coruña, A Coruña [La Coruña], Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0172
Hospitalet, Barcelona [Barcelona], Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, Spain
Hospital Beata María Ana
Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Skånes Universitetssjukhus Malmö
Malmo, Skåne Län [se-12], Sweden
Capio Saint Görans Sjukhus
Stockholm, Stockholms Län [se-01], Sweden
Akademiska sjukhuset
Uppsala, Uppsala Län [se-03], Sweden
Universitetssjukhuset Örebro
Örebro, Örebro Län [se-18], Sweden
Universitetssjukhuset i Linköping
Linköping, Östergötlands Län [se-05], Sweden
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
CHUV (centre hospitalier universitaire vaudois)
Lausanne, Canton of Vaud, Switzerland
Brust-Zentrum
Zurich, Switzerland
Local Institution - 0361
Adana, Turkey (Türkiye)
Local Institution - 0362
Ankara, Turkey (Türkiye)
Local Institution - 0364
Istanbul, Turkey (Türkiye)
Local Institution - 0363
Istanbul, Turkey (Türkiye)
Local Institution - 0323
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Local Institution - 0318
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Local Institution - 0322
Al Ain City, Abu Dhabi Emirate, United Arab Emirates
Local Institution - 0319
Abu Dhabi, United Arab Emirates
The Royal Cornwall Hospital
Truro, England, United Kingdom
St Bartholomew's Hospital
London, London, City of, United Kingdom
Guy's & St Thomas' NHS Foundation Trust
London, London, City of, United Kingdom
Local Institution - 0204
London, London, City of, United Kingdom
Local Institution - 0171
Belfast, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Local Institution - 0006
Nottingham, United Kingdom