Breast NeoplasmsPhase 2/3NCT06926868
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)
A Phase 2/3 study testing Iza-bren, Nab-paclitaxel and Paclitaxel in people with Breast Neoplasms, run by Bristol-Myers Squibb at 295 sites in 28 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Iza-bren, Nab-paclitaxel and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 295 sitesin 28 countries
- Study dates
- 11 Sep 2025to 15 May 2030
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic triple-negative breast cancer (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 American Society of Clinical Oncology/College of American Pathologists (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.
- Participants with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 (eg, pembrolizumab) or an anti-PD-L1 (eg, atezolizumab) due to any one of the following criteria:
- Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of standard of care (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, in the opinion of the investigator, for the use of an anti-PD(L)1 drug: iv) Any auto-immune disease that requires current immunosuppression (eg, methotrexate, cyclophosphamide, prednisone > 10 mg/day).
- Prior auto-immune AE to peri-adjuvant ICI that required immunosuppression. vi) Current Graves' disease with ophthalmopathy or in need of radioiodine or in use of antithyroid medication.
- Current or prior auto-immune diseases per below: A. Moderate to severe rheumatoid arthritis. B. Auto-immune hepatitis or cholangitis. C. Myasthenia gravis. D. Moderate-to-severe or poorly controlled inflammatory bowel disease. E. Multiple sclerosis. F. Lupus with kidney involvement or moderate to severe lupus. G. Auto-immune myocarditis. Note: if participant meets Inclusion Criteria 5b or 5c, unknown PDL1 results per local SOC are acceptable in these specific cases.
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- 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.
Who cannot join
- Participants with a known germline breast cancer gene (BRCA) 1 or 2 mutation whose best 1L treatment option, in the opinion of the investigator, is a poli-ADP-ribose-polymerase inhibitors (PARPi).
- Untreated symptomatic central nervous system (CNS) metastases. Participants are eligible if CNS metastases have been treated, and participants' neurological signs and symptoms have returned to baseline. In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization. Imaging performed within 28 days of randomization must document radiographic stability of CNS lesions and be performed after completion of any CNS directed therapy.
- Leptomeningeal metastases.
- Participants with history of severe heart disease including, but not limited to, any of the following:
- History of clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification II to IV, pericarditis, or significant pericardial effusion).
- Myocardial infarction, uncontrolled angina, or stroke/transient ischemic attack within the past 6 months.
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- QTc (by Fridericia's formula) prolongation ≥ 450 msec for males and ≥ 470 msec for females, except for right bundle branch block.
- Known LVEF < 50%.
- Prior therapy with iza-bren or any other ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
295 sites in 28 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
295 sites in 28 countries
United States46 sites, 38 recruiting
- Recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Nicholas Lamparella, Site 0356, 610-402-9543
- Completed
Local Institution - 0294
Atlanta, Georgia, 30322
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Amelia Zelnak, Site 0357, 770-205-5292
- Not yet recruiting
Local Institution - 0289
Aurora, Colorado, 80045
Site 0289
- Recruiting
Texas Oncology - Central/South Texas
Austin, Texas, 78705
Alvaro Restrepo, Site 0315
- Not yet recruiting
Local Institution - 1035
Baltimore, Maryland, 21201
Site 1035
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Neelima Vidula, Site 0288
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Sara Tolaney, Site 0287, 617-632-5743
- Recruiting
Helios Clinical Research
Cerritos, California, 90703
Omkar Marathe, Site 0328, 562-693-4477
- Withdrawn
Local Institution - 0307
Cerritos, California, 90703
- Withdrawn
Local Institution - 0308
Cerritos, California, 90703
- Withdrawn
Local Institution - 0309
Cerritos, California, 90703
- Withdrawn
Local Institution - 0278
Chicago, Illinois, 60612
- Not yet recruiting
Local Institution - 0280
Chicago, Illinois, 60637
Site 0280
- Recruiting
Ochsner Clinic Foundation
Covington, Louisiana, 70433
Melanie Sheen, Site 0286, 504-842-9780
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
James Wade, Site 0275, 217-876-6611
- Recruiting
Rocky Mountain Cancer Centers
Denver, Colorado, 80220
Mabel Mardones, Site 0367
- Recruiting
Henry Ford Cancer- Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, 48202
Rebecca Chacko, Site 0359, 313-530-1949
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
Carey Anders, Site 0276, 919-684-0313
- Recruiting
Texas Oncology - West Texas
El Paso, Texas, 79902
Ines Sanchez-Rivera, Site 0368, 915-544-6750
- Recruiting
Willamette Valley Cancer Institute
Eugene, Oregon, 97401
Miho Dougherty, Site 0316
- Recruiting
Texas Oncology - Northeast Texas
Flower Mound, Texas, 75028
Vibha Thomas, Site 0305, 303-925-0700
- Recruiting
St Francis Cancer Center
Greenville, South Carolina, 29607
Stephen Dyar, Site 0281, 864-603-6327
- Not yet recruiting
Local Institution - 0303
Hot Springs, Arkansas, 71913
Site 0303
- Recruiting
(USOR) Texas Oncology
Houston, Texas, 77024-2843
Dhatri Kodali, Site 0314, 555-555-5555
- Recruiting
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
Timothy Pluard, Site 0284, 314-747-7992
- Withdrawn
Local Institution - 0311
Long Beach, California, 90805
- Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Daphne Stewart, Site 0290, 323-865-3906
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
David Berz, Site 0283, 424-535-1874
- Recruiting
Minnesota Oncology Hematology
Maple Grove, Minnesota, 55369
Eric Lander, Site 0313
- Recruiting
Bon Secours St. Francis Medical Center
Midlothian, Virginia, 23114
William Irvin, Site 0277
- Not yet recruiting
Local Institution - 0372
Minneapolis, Minnesota, 55455
Site 0372
- Withdrawn
Local Institution - 0312
New York, New York, 10016
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Nour Abuhadra, Site 0279, 646-888-4451
- Recruiting
Medical Oncology Hematology Consultants, PA
Newark, Delaware, 19713
Jamal Misleh, Site 0304, 302-366-1200
- Recruiting
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663
Daphne Stewart, Site 0353, 323-397-5954
- Withdrawn
Local Institution - 0324
O'Fallon, Illinois, 62269
- Not yet recruiting
Local Institution - 0296
Pembroke Pines, Florida, 33028
Site 0296
- Recruiting
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Payal Shah, Site 0310
- Not yet recruiting
Local Institution - 0360
Pittsburgh, Pennsylvania, 15213-3403
Site 0360
- Not yet recruiting
Local Institution - 0301
Roanoke, Virginia, 24014
Site 0301
- Not yet recruiting
Local Institution - 0358
Stanford, California, 94305
Site 0358
- Not yet recruiting
Local Institution - 1037
Syracuse, New York, 13210
Site 1037
- Recruiting
Clinical Research Alliance
Westbury, New York, 11590
Jonathan Goldberg, Site 0295, 914-242-2991
- Recruiting
White Plains Hospital
White Plains, New York, 10601
Dan Costin, Site 0285, 914-849-7630
- Recruiting
Shenandoah Oncology, P.C.
Winchester, Virginia, 22601
William Houck, Site 0302, 540-662-1108
China30 sites, 29 recruiting
- Recruiting
Anyang Cancer Hospital
Anyang, Henan, 455110
Junlan Guo, Site 1004, 8615037272967
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Huiping Li, Site 1005, 8613811012595
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100142
Donggui Wan, Site 1024, 8619854715414
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, BEI, 100021
Binghe Xu, Site 1001, +86 13501028690
- Not yet recruiting
Local Institution - 1012
Changchun, Liaoning, 130021
Site 1012
- Not yet recruiting
Local Institution - 1011
Changsha, HUN, 410013
Site 1011
- Recruiting
Sichuan Provincial People'S Hospital
Chengdu, Sichuan, 610072
Jing Luo, Site 1019, 8618981838521
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Fan Wu, Site 1006, 8613859082118
- Recruiting
Fujian Medical University Union Hospital
Fyzhou, Fujian, 350001
Fangmeng Fu, Site 1007, 8613365917923
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, 510060
Shusen Wang, Site 1025, 8613926168469
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310024
Peifen Fu, Site 1023, 8613958161556
- Recruiting
The First Hospital of harbin University
Harbin, Harbin, 150001
Li Cai, Site 1028, 8613313602929
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230001
Nannan Lu, Site 1002, 8618130056850
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
Fanfan Li, Site 1003, +8613855137365
- Recruiting
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
Huihui Li, Site 1017, 8615553103209
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Guojun Zhang, Site 1029, 8618850064298
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Xiaoling Ling, Site 1031, 8618693165668
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Zhengkui Sun, Site 1013, 8613907000210
- Recruiting
Guangxi Medical University Affiliated Cancer Hospital
Nanning, Guangxi, 530021
Wei Wei, Site 1008, 8618577071966
- Recruiting
The Affiliated Hospital Of Qingdao University
Qingdao, Shandong, 266071
Haibo Wang, Site 1015, 8618661805787
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 140001
Tao Sun, Site 1014, 8613940404526
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 650118
Guohui Han, Site 1018, 8613454858188
- Recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300060
Chunfang Hao, Site 1027, 8613602031629
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 301000
Yedong Shi, Site 1020, 8618622221183
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430061
Haijun Yu, Site 1021, 8613971665181
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430070
Xinhong Wu, Site 1010, 8618602726300
- Withdrawn
Local Institution - 1016
Xiamen, Fujian, 361003
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441000
Yuehua Wang, Site 1022, 8613995777482
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Min Yan, Site 1009, 8615713857388
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Wei He, Site 1032, +8618638553286
Japan25 sites, 25 recruiting
- Not yet recruiting
Local Institution - 0231
Bunkyo-ku, Tokyo, 113-8431
Site 0231
- Not yet recruiting
Local Institution - 0230
Chiba, Chiba, 260-8717
Site 0230
- Not yet recruiting
Local Institution - 0229
Chuo-ku, Tokyo, 104-0045
Site 0229
- Not yet recruiting
Local Institution - 0242
Fukuoka, 811-1395
Site 0242
- Not yet recruiting
Local Institution - 0225
Fukushima, 960-1295
Site 0225
- Not yet recruiting
Local Institution - 0227
Hidaka, Saitama, 350-1298
Site 0227
- Not yet recruiting
Local Institution - 0243
Hiroshima, 7308518
Site 0243
- Not yet recruiting
Local Institution - 0224
Ina-machi, Saitama, 362-0806
Site 0224
- Not yet recruiting
Local Institution - 0234
Isehara, Kanagawa, 259-1193
Site 0234
- Not yet recruiting
Local Institution - 0244
Kagoshima, 892-0833
Site 0244
- Not yet recruiting
Local Institution - 0232
Kanazawa, Ishikawa-ken, 920-8530
Site 0232
- Not yet recruiting
Local Institution - 0228
Koto, Tokyo, 135-8550
Site 0228
- Not yet recruiting
Local Institution - 0235
Kyoto, 606-8507
Site 0235
- Not yet recruiting
Local Institution - 0240
Matsuyama, Ehime, 791-0280
Site 0240
- Not yet recruiting
Local Institution - 0236
Nagoya, Aichi-ken, 464-8681
Site 0236
- Not yet recruiting
Local Institution - 0241
Okayama, 700-8558
Site 0241
- Not yet recruiting
Local Institution - 0239
Osaka, 541-8567
Site 0239
- Not yet recruiting
Local Institution - 0226
Otashi, Gunma, 373-8550
Site 0226
- Not yet recruiting
Local Institution - 0222
Sapporo, Hokkaido, 003-0804
Site 0222
- Not yet recruiting
Local Institution - 0223
Sendai, Miyagi, 980-8574
Site 0223
- Not yet recruiting
Local Institution - 0245
Shinagawa, Tokyo, 142-8666
Site 0245
- Not yet recruiting
Local Institution - 0233
Shinjuku-ku, Tokyo, 160-0023
Site 0233
- Not yet recruiting
Local Institution - 0238
Suita, Osaka, 565-0871
Site 0238
- Not yet recruiting
Local Institution - 0246
Tsu, Mie-ken, 514-8507
Site 0246
- Not yet recruiting
Local Institution - 0237
Yokohama, Kanagawa, 2418515
Site 0237
Germany16 sites, 15 recruiting
- Recruiting
Klinikum Augsburg
Augsburg, Bavaria, 86156
Nina Ditsch, Site 0256, 00498214002208
- Recruiting
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, 10117
Caroline Neeb, Site 0261, +4930450664484
- Recruiting
Vivantes Klinikum Am Urban
Berlin, 10967
Christian Scholz, Site 0260, 004930130222100
- Recruiting
Gynaekologisches Zentrum Bonn
Bonn, 53111
Christian Kurbacher, Site 0259, +4922890927671
- Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Theresa Link, Site 0258, 4935145818084
- Completed
Local Institution - 0293
Düsseldorf, North Rhine-Westphalia, 40235
- Recruiting
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, North Rhine-Westphalia, 45136
Jennifer Spoenlein, Site 0263, 020117433092
- Recruiting
Klinikum Esslingen
Esslingen am Neckar, Baden-Wurttemberg, 73730
Alexander Hein, Site 0320, +4971131033051
- Recruiting
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt am Main, Hesse, 60590
Christine Solbach, Site 0306, +4916096965363
- Recruiting
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Tjoung-Won Park-Simon, Site 0257, 495115329545
- Recruiting
Universitaetsklinikum Heidelberg
Heidelberg, D-69120
Carlo Fremd, Site 0262, 004962215634970
- Recruiting
Gemeinschaftspraxis für Hämatologie und Onkologie
Langen, Hesse, 63225
Andreas Köhler, Site 0333, +4961033018276
- Not yet recruiting
Local Institution - 0254
Leipzig, Saxony, 04103
Site 0254
- Recruiting
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Maggie Banys-Paluchowski, Site 0255, 004945150041700
- Recruiting
Rotkreuzklinikum München gemeinnützige GmbH
München, Bavaria, 80637
Michael Braun, Site 0271, 00498913033797
- Recruiting
Universitaetsklinikum Ulm
Ulm, 89081
Sabine Heublein, Site 0291, +4973150058523
France14 sites, 11 recruiting
- Recruiting
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine, 33076
Celine Blaye, Site 0089, 555-555-5555
- Recruiting
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, Puy-de-Dôme, 63011
Marie-Ange Mouret-Reynier, Site 0096, 33473278005
- Recruiting
Centre Georges François Leclerc
Dijon, Côte-d'Or, 21079
Sylvain Ladoire, Site 0272, 33380737506
- Recruiting
Centre Oscar Lambret
Lille, 59000
Nawale Hajjaji, Site 0094, +33247478261
- Not yet recruiting
Local Institution - 0090
Lyon, Auvergne-Rhône-Alpes, 69008
Site 0090
- Recruiting
Institut Paoli-Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, 13273
Alexandre Tassin de Nonneville, Site 0093, 0033621713044
- Recruiting
Institut Régional du Cancer Montpellier
Montpellier, Hérault, 34298
Marie Alexandre, Site 0095, 33467612393
- Withdrawn
Local Institution - 0088
Paris, 75248
- Not yet recruiting
Local Institution - 1033
Poitiers, Vienne, 86021
Site 1033
- Withdrawn
Local Institution - 0091
Reims, Marne, 51726
- Recruiting
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer
Rennes, Ille-et-Vilaine, 35042
Perrine VUAGNAT, Site 0099, 3362299252969
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire-Atlantique, 44805
Mario Campone, Site 0092, 33240679977
- Withdrawn
Local Institution - 0098
Toulouse, Haute-Garonne, 31059
- Recruiting
Gustave Roussy
Villejuif, Paris, 94800
Thomas Grinda, Site 0097, 0142114211
Spain12 sites, 12 recruiting
- Recruiting
CHUAC-Hospital Teresa Herrera
A Coruña, A Coruña [La Coruña], 15006
Silvia Antolin Novoa, Site 0105, +34981178000
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035
Ana Mafalda Antunes de Melo e Oliveira, Site 0102, 34934894158
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], 08036
Marta González Rodríguez, Site 0140, +34606895621
- Recruiting
Hospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, 20014
Isabel Alvarez Lopez, Site 0139, 34943006002
- Recruiting
Hospital General Universitario de Elche
Elche, Alicante, 03203
Álvaro Rodríguez-Lescure, Site 0100, 111-111-1111
- Recruiting
Institut Català d'Oncologia - L'Hospitalet
Hospitalet, Barcelona [Barcelona], 08907
Agostina Stradella Trucco, Site 0172, 34932607744
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Comunidad de, 28009
Sara Lopez Tarruella, Site 0104, 34914269392
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041
Eva María Ciruelos Gil, Site 0108, 34913908000
- Recruiting
Hospital Beata María Ana
Madrid, 28007
Javier Cortes Castán, Site 0107, 34911175021
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29010
Maria Emilia Dominguez Recio, Site 0101, 34951291425
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Luis de la Cruz Merino, Site 0103, +34955926578
- Recruiting
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010
Begona Bermejo de las Heras, Site 0210, 34961973583
Brazil11 sites, 10 recruiting
- Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400
Karina Oikawa, Site 0148, 1733216600
- Recruiting
Centro Integrado de Oncologia de Curitiba
Curitiba, Paraná, 81480-580
Karina Vianna, Site 0159, +554130242421
- Recruiting
Oncocentro Oncologia
Fortaleza, Ceará, 60135-237
Roberto Furlani, Site 0147, +5585999211461
- Not yet recruiting
Local Institution - 1038
Lago Sul, Federal District, 71681-603
Site 1038
- Withdrawn
Local Institution - 0187
Manaus, Amazonas, 69020-030
- Recruiting
Futtura Oncology - Clinical Research Hub
Porto Alegre, Rio Grande do Sul, 90470-340
Gustavo Werutsky, Site 0199, 51995868013
- Recruiting
Instituto Nacional de Câncer - INCA
Rio de Janeiro, 20230-130
Susanne Crocamo V Da Costa, Site 0153, 552125774242
- Not yet recruiting
Local Institution - 0164
São José do Rio Preto, São Paulo, 15090-000
Site 0164
- Recruiting
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
São Paulo, 01317-000
Roberto Hegg, Site 0144, 5511991931500
- Recruiting
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, 01401-002
Renata Bonadio, Site 0149, +5511989554040
- Recruiting
CEDOES
Vitória, Espírito Santo, 29055450
Mauricio Pereira, Site 0157, +5521998795727
Italy11 sites, 11 recruiting
- Recruiting
Cro-Irccs
Aviano, Friuli Venezia Giulia, 33081
Fabio Puglisi, Site 0057, +393663239989
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, 40138
Claudio Zamagni, Site 0049, +390512144548
- Recruiting
Ospedale San Martino
Genoa, Liguria, 16132
Lucia Del Mastro, Site 0054, 390105558908
- Recruiting
Istituto Europeo di Oncologia IRCCS
Milan, 20141
Giuseppe Curigliano, Site 0052, 390257490439
- Recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Campania, 80131
Michelino De Laurentiis, Site 0051, +3908117770442
- Recruiting
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
Grazia Arpino, Site 0058, 390817463660
- Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
Alessandra Gennari, Site 0061, 03213733822
- Recruiting
Istituto Oncologico Veneto IRCCS
Padova, 35128
Valentina Guarneri, Site 0056, 00390498215931
- Recruiting
Ospedale "Felice Lotti" Di Pontedera
Pontedera, Pisa, 56025
Luigi Coltelli, Site 0053, 0586223416
- Recruiting
Nuovo Ospedale di Prato-S.Stefano
Prato, Tuscany, 59100
Laura Biganzoli, Site 0055, 390574802532
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168
Alessandra Fabi, Site 0062, 00390630157983
Romania11 sites, 11 recruiting
- Not yet recruiting
Local Institution - 0212
Bistriţa, Bistrița-Năsăud County, 420020
Site 0212
- Not yet recruiting
Local Institution - 0213
Bucharest, Bucharest, 012292
Site 0213
- Recruiting
Spitalul Clinic Filantropia
Bucharest, 011171
Mircea Median, Site 0083, 40744874350
- Recruiting
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Nicoleta Antone, Site 0077, 40740226786
- Recruiting
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, 200746
Michael Schenker, Site 0078, 40727774974
- Recruiting
Centrul de Radioterapie Amethyst Timis
Dumbrăviţa, 307160
Elena Boscuta, Site 0211, 40784019019
- Recruiting
SC Radiotherapy Center Cluj SRL
Florești, Cluj, 407280
Andrei Ungureanu, Site 0079, 40742206212
- Recruiting
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași, 700106
Simona Volovat, Site 0081, 0040742024148
- Recruiting
Institutul Regional de Oncologie
Iași, 700483
Eva Maria Cojocaru, Site 0080, +40740030860
- Recruiting
Spitalul Municipal Schuller Ploiești
Ploieşti, 100337
Pompilia Motatu, Site 0084, +40723943507
- Recruiting
Oncohelp Medical Center
Timișoara, Timiș County, 300239
Cristina Oprean, Site 0085, +40745148485
Argentina10 sites, 10 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., 1181
Maria Riggi, Site 0214, 5491165379382
- Recruiting
Instituto Argentino de Diagnóstico y Tratamiento (IADT)
Buenos Aires, 1122
Juan Cundom, Site 0345, (+54911)4162-5353
- Recruiting
Centro Oncologico Korben
Buenos Aires, 1426
Ernesto Korbenfeld, Site 0317, 54911563819972
- Recruiting
Instituto Alexander Fleming
Buenos Aires, 1426
Adrian Nervo, Site 0012, +54932218900
- Not yet recruiting
Local Institution - 0346
Buenos Aires, 1430
Site 0346
- Not yet recruiting
Local Institution - 0011
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280
Site 0011
- Recruiting
Hospital Italiano de Córdoba
Córdoba, Córdoba Province, X5004BAL
Virginia Garcia, Site 0143, +5493515054293
- Recruiting
Fundación Oncológica Mendoza
Mendoza, 5500
RUBEN RIZZO, Site 0348, +5492615109921
- Recruiting
Centro Privado de RMI Río Cuarto S.A. II
Río Cuarto, Córdoba Province, X5800ALB
Alejo Lingua, Site 0137, 54351153819050
- Recruiting
Sanatorio Plaza
Rosario, Santa Fe Province, 2000
Miriam Raimondo, Site 0142, +549341644-8821
Mexico10 sites, 9 recruiting
- Recruiting
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207
Enrique Zamudio Lozoya, Site 0174, 6146883416
- Not yet recruiting
Local Institution - 0178
Guadalajara, Jalisco, 44680
Site 0178
- Not yet recruiting
Local Institution - 0179
Mérida, Yucatán, 97000
Site 0179
- Recruiting
CENEIT Oncologicos
Mexico City, DIF, 03100
Alberto Suarez Zaizar, Site 0177, 525555342400
- Not yet recruiting
Local Institution - 0329
Mexico City, Mexico City, 14070
Site 0329
- Not yet recruiting
Local Institution - 0175
Monterrey, Nuevo León, 64320
Site 0175
- Not yet recruiting
Local Institution - 0176
Monterrey, Nuevo León, 64460
Site 0176
- Withdrawn
Local Institution - 0355
Monterrey, Nuevo León, 64460
- Not yet recruiting
Local Institution - 0173
Oaxaca City, Oaxaca, 68020
Site 0173
- Not yet recruiting
Local Institution - 0264
Tijuana, Estado de Baja California, 22010
Site 0264
India9 sites, 7 recruiting
- Not yet recruiting
Local Institution - 0125
Chennai, Tamil Nadu, 600035
Site 0125
- Not yet recruiting
Local Institution - 0130
Hyderabad, Telangana, 500082
Site 0130
- Withdrawn
Local Institution - 0337
Mumbai, Maharashtra, 400 057
- Not yet recruiting
Local Institution - 0131
Mumbai, Maharashtra, 400012
Site 0131
- Not yet recruiting
Local Institution - 0134
Nagpur, Maharashtra, 440001
Site 0134
- Withdrawn
Local Institution - 0352
New Delhi, National Capital Territory of Delhi, 110017
- Not yet recruiting
Local Institution - 0266
New Delhi, National Capital Territory of Delhi, 110029
Site 0266
- Not yet recruiting
Local Institution - 0206
New Delhi, National Capital Territory of Delhi, 110085
Site 0206
- Not yet recruiting
Local Institution - 0133
Varanasi, Uttar Pradesh, 221005
Site 0133
Colombia8 sites, 6 recruiting
- Not yet recruiting
Local Institution - 0194
Barranquilla, Atlántico, 080020
Site 0194
- Not yet recruiting
Local Institution - 0327
Bogota, Cundinamarca, 111151
Site 0327
- Not yet recruiting
Local Institution - 0183
Cali, Valle del Cauca Department, 760032
Site 0183
- Withdrawn
Local Institution - 0195
Medellín, Antioquia, 50021
- Not yet recruiting
Local Institution - 0349
Medellín, 050030
Site 0349
- Not yet recruiting
Local Institution - 0181
Montería, COR, 230002
Site 0181
- Withdrawn
Local Institution - 0182
Puerto Colombia, Atlántico, 81001
- Not yet recruiting
Local Institution - 0201
Rionegro, Antioquia, 054047
Site 0201
South Korea8 sites, 8 recruiting
- Not yet recruiting
Local Institution - 0069
Daegu, Taegu-Kwangyǒkshi, 41404
Site 0069
- Not yet recruiting
Local Institution - 0066
Goyang-si, Kyǒnggi-do, 10408
Site 0066
- Not yet recruiting
Local Institution - 0067
Seongnam, Kyǒnggi-do, 13620
Site 0067
- Not yet recruiting
Local Institution - 0068
Seoul, Seoul-teukbyeolsi [Seoul], 02841
Site 0068
- Not yet recruiting
Local Institution - 0063
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Site 0063
- Not yet recruiting
Local Institution - 0071
Seoul, Seoul-teukbyeolsi [Seoul], 03722
Site 0071
- Not yet recruiting
Local Institution - 0064
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Site 0064
- Not yet recruiting
Local Institution - 0065
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Site 0065
Canada7 sites, 7 recruiting
- Recruiting
BC Cancer Kelowna
Kelowna, British Columbia, V1Y 5L3
Susan Ellard, Site 0218, +1250-712-3996
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
Danielle Charpentier, Site 0215, 5148908000
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Jamil Asselah, Site 0219, 514934193435721
- Recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Xinni Song, Site 0265, 6137377700ext70208
- Recruiting
Centre Intégré de Santé et de Services Sociaux de Lanaudière
Saint-Charles-Borromée, Quebec, J6E 6J2
Angélique Brunot, Site 0350, 579-593-1172
- Recruiting
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS
Sherbrooke, Quebec, J1H 5N4
Michel Pavic, Site 0216, 819-346-1110x74816
- Not yet recruiting
Local Institution - 0217
Victoria, British Columbia, V8R 6V5
Site 0217
Portugal7 sites, 7 recruiting
- Recruiting
Instituto Portugês de Oncologia de Coimbra Francisco Gentil
Coimbra, 3000-075
Gabriela Sousa, Site 0124, +351239400200
- Recruiting
Instituto Português de Oncologia de Lisboa Francisco Gentil
Lisbon, Lisbon District, 1099-023
Patricia Pereira, Site 0198
- Not yet recruiting
Local Institution - 0106
Lisbon, Lisbon District, 1400-038
Site 0106
- Recruiting
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, Lisbon District, 1649-035
Luis Costa, Site 0109, 351217805257
- Recruiting
Hospital da Luz Lisboa
Lisbon, 1500-650
Catarina Pulido, Site 0141, +351917187738
- Recruiting
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072
Cristina Oliveira, Site 0111
- Recruiting
Centro Hospitalar de Sao Joao - Hospital de Sao Joao
Porto, 4200-319
Isabel Augusto, Site 0253, +351963903409
United Kingdom7 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0171
Belfast, BT9 7AB
Site 0171
- Active, not recruiting
Local Institution - 0004
London, London, City of, EC1A 7BE
- Withdrawn
Local Institution - 0204
London, London, City of, SE1 9RT
- Active, not recruiting
Local Institution - 0209
London, London, City of, SE1 9RT
- Active, not recruiting
Local Institution - 0001
Manchester, M20 4BX
- Not yet recruiting
Local Institution - 0006
Nottingham, NG5 1PB
Site 0006
- Active, not recruiting
Local Institution - 0208
Truro, England, TR1 3LJ
Australia6 sites, 6 recruiting
- Recruiting
Grampians Health
Ballarat Central, Victoria, 3350
LeeNa Teo, Site 0197, +61409338111
- Recruiting
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Po-ling Inglis, Site 0035, 61736468111
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
Belinda Yeo, Site 0031, 0450737873
- Recruiting
Macquarie University
Macquarie University, New South Wales, 2109
Dhanusha Sabanathan, Site 0170, 98122973
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Peter Savas, Site 0274, +61402147682
- Recruiting
St. John of God Subiaco Hospital
Subiaco, Western Australia, 6008
Daphne Tsoi, Site 0028, 61864659200
Poland6 sites, 5 recruiting
- Withdrawn
Local Institution - 0074
Biała Podlaska, Lublin Voivodeship, 21-500
- Recruiting
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, 93-338
Ewa Kalinka, Site 0221, 530770073
- Not yet recruiting
Local Institution - 0076
Opole, Opole Voivodeship, 45-061
Site 0076
- Recruiting
AIDPORT Sp. z o.o.
Skórzewo, Greater Poland Voivodeship, 60-185
Renata Szoszkiewicz, Site 0189, +48696446632
- Not yet recruiting
Local Institution - 0072
Warsaw, Masovian Voivodeship, 02-781
Site 0072
- Recruiting
Mazowiecki Szpital Onkologiczny
Warsaw, Masovian Voivodeship, 03-411
Michal Kunkiel, Site 0220, 48606655734
South Africa6 sites, 6 recruiting
- Not yet recruiting
Local Institution - 0351
East London, Eastern Cape, 5241
Site 0351
- Not yet recruiting
Local Institution - 0342
Johannesburg, 2193
Site 0342
- Not yet recruiting
Local Institution - 1034
Panorama, Western Cape, 7500
Site 1034
- Not yet recruiting
Local Institution - 0336
Pretoria, 0001
Site 0336
- Not yet recruiting
Local Institution - 0341
Pretoria, 0084
Site 0341
- Not yet recruiting
Local Institution - 0340
Soweto, 2013
Site 0340
Austria5 sites, 5 recruiting
- Recruiting
Medizinische Universität Graz
Graz, Styria, 8036
Vassiliki Kolovetsiou Kreiner, Site 0292, 4331638580643
- Recruiting
Medizinische Universitaet Innsbruck
Innsbruck, Tyrol, 6020
Daniel Egle, Site 0268, 004351250481503
- Recruiting
Uniklinikum Salzburg
Salzburg, 5020
Simon Gampenrieder, Site 0267, 435725558858
- Recruiting
Universitätsklinikum St. Pölten
Sankt Pölten, 3100
Maria Gold, Site 0270, 00432742900422175
- Recruiting
Medizinische Universität Wien
Vienna, 1090
Rupert Bartsch, Site 0269, 43140400444500
Chile5 sites, 5 recruiting
- Recruiting
FALP
Santiago, Santiago Metropolitan, 7500921
Felipe Reyes, Site 0138, 56975798360
- Recruiting
Clínica Alemana de Santiago
Santiago, Santiago Metropolitan, 7650568
Jose Sola, Site 0021, +56994016361
- Recruiting
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 8330032
Cesar Sanchez, Site 0017, 56223546919
- Recruiting
Bradfordhill
Santiago, Santiago Metropolitan, 8420383
Carlos Gallardo, Site 0018, +56978878489
- Recruiting
Oncocentro Apys
Viña del Mar, Valparaiso, 2520598
Alejandro Acevedo Gaete, Site 0016, +56992369820
Israel5 sites, 5 recruiting
- Recruiting
Hillel Yaffe Medical Center
Hadera, Northern District, 38100
Salome Khutsurauli, Site 0048, 972528730448
- Recruiting
Rambam Health Care Campus
Haifa, Northern District, 3109601
Ayelet Shai, Site 0123, 972-4-777-6700
- Recruiting
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001
Shani Paluch-Shimon, Site 0047, 972542626027
- Not yet recruiting
Local Institution - 0186
Petah Tikva, Central District, 4941492
Site 0186
- Recruiting
Sheba Medical Center
Ramat Gan, Central District, 5265601
Einav Nili-Gal-Yam, Site 0044, 972-3-5304961
Sweden5 sites
- Active, not recruiting
Local Institution - 0247
Linköping, Östergötlands Län [se-05], 581 85
- Active, not recruiting
Local Institution - 0252
Malmö, Skåne Län [se-12], 205 02
- Active, not recruiting
Local Institution - 0024
Örebro, Örebro Län [se-18], 701 85
- Active, not recruiting
Local Institution - 0026
Stockholm, Stockholms Län [se-01], 112 19
- Active, not recruiting
Local Institution - 0025
Uppsala, Uppsala Län [se-03], 751 85
Greece4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0043
Athens, Attikí (Region), 115 28
Site 0043
- Recruiting
Agios Savvas Regional Cancer Hospital
Athens, Attikí, 115 22
Dimitrios Tryfonopoulos, Site 0042, +306932669110
- Not yet recruiting
Local Institution - 0038
Athens, Attikí, 185 47
Site 0038
- Recruiting
University General Hospital of Heraklion
Heraklion, Irakleío, 715 00
Dimitrios Mavroudis, Site 0086, 302810392750
Turkey (Türkiye)4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0361
Adana, 01123
Site 0361
- Not yet recruiting
Local Institution - 0362
Ankara, 06800
Site 0362
- Not yet recruiting
Local Institution - 0364
Istanbul, 34010
Site 0364
- Not yet recruiting
Local Institution - 0363
Istanbul, 34722
Site 0363
United Arab Emirates4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0323
Abu Dhabi, Abu Dhabi Emirate, 11001
Site 0323
- Not yet recruiting
Local Institution - 0318
Abu Dhabi, Abu Dhabi Emirate, 92510
Site 0318
- Not yet recruiting
Local Institution - 0319
Abu Dhabi, 0
Site 0319
- Not yet recruiting
Local Institution - 0322
Al Ain City, Abu Dhabi Emirate, 15258
Site 0322
Switzerland3 sites, 3 recruiting
- Recruiting
CHUV (centre hospitalier universitaire vaudois)
Lausanne, Canton of Vaud, 1011
Athina Stravodimou, Site 0249, 0041795564117
- Recruiting
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Jens Huober, Site 0250, 0714941880
- Recruiting
Brust-Zentrum
Zurich, 8008
Elena Kralidis, Site 0251, 41445338132
About this study
Official title: IZABRIGHT-Breast01: A Randomized, Open-label, 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.
- Conditions
- Breast Neoplasms
- Being tested
- Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
- Keywords
- triple-negative breast cancer, antibody-drug conjugate, ER-low/HER2-negative breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iza-brenDrug
Also called BMS-986507, BL-B01D1, Izalontamab brengitecan
Specified dose on specified days
Nab-paclitaxelDrug
Specified dose on specified days
PaclitaxelDrug
Specified dose on specified days
CapecitabineDrug
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
GemcitabineDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A1 | Experimental | Not described Receives: Drug: Iza-bren |
| Arm A2 | Experimental | Not described Receives: Drug: Iza-bren |
| Arm B | Active comparator | Not described Receives: Drug: Nab-paclitaxel; Drug: Paclitaxel; Drug: Capecitabine; Drug: Carboplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)
Measured: Approximately 22 months from first participant randomization in Phase 3
Recommended Phase 3 Dose (RP3D) of BMS-986507
Measured: Approximately 13 months from first participant randomization in Phase 2
Secondary outcomes (24)
Overall Survival (OS)
Measured: Approximately up to 47 months from first participant randomization in Phase 3
Number of participants with treatment-related Adverse Events (AEs)
Measured: Approximately up to 47 months from first participant randomization in Phase 3
Number of participants with laboratory abnormalities
Measured: Approximately up to 47 months from first participant randomization in Phase 3
Number of participants with serious AEs (SAEs)
Measured: Approximately up to 47 months from first participant randomization in Phase 3
Number of participants with AEs leading to treatment discontinuation, interruption, dose reduction or dose delay
Measured: Approximately up to 47 months from first participant randomization in Phase 3
Number of deaths
Measured: Approximately up to 47 months from first participant randomization in Phase 3
Objective Response (OR) per BICR
Measured: Approximately 22 months from first participant randomization in Phase 3
Objective Response (OR) per Investigator
Measured: Approximately 22 months from first participant randomization in Phase 3
PFS rate
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by BICR
Measured: Approximately 22 months from first participant randomization in Phase 3
PFS rate
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by Investigator
Measured: Approximately 22 months from first participant randomization in Phase 3
Relative change in tumor size
Measured: Approximately 22 months from first participant randomization in Phase 3
Disease control rate (DCR) per BICR
Measured: Approximately 22 months from first participant randomization in Phase 3
Disease control rate (DCR) per Investigator
Measured: Approximately 22 months from first participant randomization in Phase 3
PFS
Assessed by Investigator
Measured: Approximately 22 months from first participant randomization in Phase 3
Duration of Response (DOR) per BICR
Measured: Approximately 22 months from first participant randomization in Phase 3
Duration of response (DOR) per Investigator
Measured: Approximately 22 months from first participant randomization in Phase 3
Time to Response (TTR) per BICR
Measured: Approximately 22 months from first participant randomization in Phase 3
Time to response (TTR) per Investigator
Measured: Approximately 22 months from first participant randomization in Phase 3
Time to subsequent treatment (TTST) per Investigator
Defined as time from randomization to the start of subsequent therapy or death
Measured: Approximately up to 47 months from first participant randomization in Phase 3
Progression-free survival after next line of treatment (PFS2)
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
Measured: Approximately up to 47 months from first participant randomization in Phase 3
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Measured: Approximately up to 47 months from first participant randomization in Phase 3
Change from baseline in EORTC Breast Cancer-specific Quality of Life Questionnaire (QLQ-BR23)
Measured: Approximately up to 47 months from first participant randomization in Phase 3
Functional Assessment of Chronic Illness Therapy item GP5 (FACIT GP5) score
Measured: Approximately up to 47 months from first participant randomization in Phase 3
Change from baseline in European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)
Measured: Approximately up to 47 months from first participant randomization in Phase 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start11 Sep 2025
- Primary completion13 Mar 2028 (estimated)
- Study completion15 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SystImmune Inc.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926868
- Sponsor's protocol ID
- CA244-0008
- Other IDs
- 2024-519871-24, U1111-1316-1533
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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