RecruitingPhase II/III🇵🇱 PolandEN original

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)

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony nowotwór piersi typu TNBC (trójujemny) lub nowotwór z niskim poziomem receptora estrogenowego, który rozprzestrzenia się lokalnie, nawraca lub przerzutuje
  • W przypadku nawrotu choroby: przerwę co najmniej 6 miesięcy od ostatniego leczenia przed powrotem objawów
  • Pacjenci z TNBC nie mogą być kwalifikowani do pierwszej linii chemioterapii ze środkami immunoterapii (anty-PD-1 lub anty-PD-L1) ze względu na brak ekspresji PD-L1, wcześniejszy nawrót po immunoterapii lub poważne choroby autoimmunologiczne
  • Pacjenci z nowotworem ER-low HER2-ujemnym nie mogą być kwalifikowani do leczenia hormonalnego
  • Brak wcześniejszego leczenia systemowego w przypadku zaawansowanej lub przerzutowej choroby
  • Mierzalne zmiany guza widoczne w tomografii komputerowej lub rezonansie magnetycznym

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 10, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (295)

Local Institution - 0303

Hot Springs, United States

Helios Clinical Research

Cerritos, United States

Local Institution - 0307

Cerritos, United States

Local Institution - 0308

Cerritos, United States

Local Institution - 0309

Cerritos, United States

Local Institution - 0311

Long Beach, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, United States

Valkyrie Clinical Trials

Los Angeles, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, United States

Local Institution - 0358

Stanford, United States

Local Institution - 0289

Aurora, United States

Rocky Mountain Cancer Centers

Denver, United States

Medical Oncology Hematology Consultants, PA

Newark, United States

Local Institution - 0296

Pembroke Pines, United States

Local Institution - 0294

Atlanta, United States

Northside Hospital

Atlanta, United States

Local Institution - 0278

Chicago, United States

Local Institution - 0280

Chicago, United States

Decatur Memorial Hospital

Decatur, United States

Local Institution - 0324

O'Fallon, United States

Ochsner Clinic Foundation

Covington, United States

Local Institution - 1035

Baltimore, United States

Massachusetts General Hospital

Boston, United States

Dana-Farber Cancer Institute

Boston, United States

Henry Ford Cancer- Detroit (Brigitte Harris Cancer Pavilion)

Detroit, United States

Minnesota Oncology Hematology

Maple Grove, United States

Local Institution - 0372

Minneapolis, United States

Saint Luke's Cancer Institute

Kansas City, United States

Local Institution - 0312

New York, United States

Memorial Sloan Kettering Cancer Center

New York, United States

Local Institution - 1037

Syracuse, United States

Clinical Research Alliance

Westbury, United States

White Plains Hospital

White Plains, United States

Duke Cancer Institute

Durham, United States

Willamette Valley Cancer Institute

Eugene, United States

Lehigh Valley Health Network

Allentown, United States

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, United States

Local Institution - 0360

Pittsburgh, United States

St Francis Cancer Center

Greenville, United States

Texas Oncology - Central/South Texas

Austin, United States

Texas Oncology - West Texas

El Paso, United States

Texas Oncology - Northeast Texas

Flower Mound, United States

(USOR) Texas Oncology

Houston, United States

Bon Secours St. Francis Medical Center

Midlothian, United States

Local Institution - 0301

Roanoke, United States

Shenandoah Oncology, P.C.

Winchester, United States

Local Institution - 0011

Ciudad Autónoma de Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

ABB, Argentina

Hospital Italiano de Córdoba

Córdoba, Argentina

Centro Privado de RMI Río Cuarto S.A. II

Río Cuarto, Argentina

Sanatorio Plaza

Rosario, 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, Australia

Royal Brisbane and Women's Hospital

Brisbane, Australia

Grampians Health

Ballarat Central, Australia

Austin Health

Heidelberg, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

St. John of God Subiaco Hospital

Subiaco, Australia

Medizinische Universität Graz

Graz, Austria

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Uniklinikum Salzburg

Salzburg, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Austria

Medizinische Universität Wien

Vienna, Austria

Local Institution - 0187

Manaus, Brazil

Oncocentro Oncologia

Fortaleza, Brazil

CEDOES

Vitória, Brazil

Local Institution - 1038

Lago Sul, Brazil

Centro Integrado de Oncologia de Curitiba

Curitiba, Brazil

Futtura Oncology - Clinical Research Hub

Porto Alegre, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, Brazil

Local Institution - 0164

São José do Rio Preto, 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, Canada

Local Institution - 0217

Victoria, Canada

The Ottawa Hospital - General Campus

Ottawa, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Canada

McGill University Health Centre

Montreal, Canada

Centre Intégré de Santé et de Services Sociaux de Lanaudière

Saint-Charles-Borromée, Canada

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS

Sherbrooke, Canada

FALP

Santiago, Chile

Clínica Alemana de Santiago

Santiago, Chile

Pontificia Universidad Catolica de Chile

Santiago, Chile

Bradfordhill

Santiago, Chile

Oncocentro Apys

Viña del Mar, Chile

Anhui Provincial Hospital

Hefei, China

The Second Hospital of Anhui Medical University

Hefei, China

Beijing Cancer Hospital

Beijing, China

China-Japan Friendship Hospital

Beijing, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Fujian Cancer Hospital

Fuzhou, China

Fujian Medical University Union Hospital

Fyzhou, China

Local Institution - 1016

Xiamen, China

The First Hospital of Lanzhou University

Lanzhou, China

Guangxi Medical University Affiliated Cancer Hospital

Nanning, China

The First Hospital of harbin University

Harbin, China

Anyang Cancer Hospital

Anyang, China

Henan Cancer Hospital

Zhengzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Zhongnan Hospital of Wuhan University

Wuhan, China

Hubei Cancer Hospital

Wuhan, China

Xiangyang Central Hospital

Xiangyang, China

Local Institution - 1011

Changsha, China

Jiangxi Cancer Hospital

Nanchang, China

Local Institution - 1012

Changchun, China

Local Institution - 1014

Shenyang, China

Cancer Hospital of Shandong First Medical University

Jinan, China

The Affiliated Hospital Of Qingdao University

Qingdao, China

Shanxi Cancer Hospital

Taiyuan, China

Sichuan Provincial People'S Hospital

Chengdu, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Yunnan Cancer Hospital

Kunming, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Sun Yat-sen University Cancer Center

Guangzhou, China

Local Institution - 0195

Medellín, Colombia

Local Institution - 0201

Rionegro, Colombia

Local Institution - 0194

Barranquilla, Colombia

Local Institution - 0182

Puerto Colombia, Colombia

Local Institution - 0181

Montería, Colombia

Local Institution - 0327

Bogota, Colombia

Local Institution - 0183

Cali, Colombia

Local Institution - 0349

Medellín, Colombia

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, France

Local Institution - 0090

Lyon, France

Centre Georges François Leclerc

Dijon, France

Local Institution - 0098

Toulouse, France

Institut Régional du Cancer Montpellier

Montpellier, France

Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer

Rennes, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Local Institution - 0091

Reims, France

Gustave Roussy

Villejuif, France

Institut Paoli-Calmettes

Marseille, France

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

Clermont-Ferrand, France

Local Institution - 1033

Poitiers, France

Centre Oscar Lambret

Lille, France

Local Institution - 0088

Paris, France

Klinikum Esslingen

Esslingen am Neckar, Germany

Klinikum Augsburg

Augsburg, Germany

Rotkreuzklinikum München gemeinnützige GmbH

München, Germany

Universitätsklinikum Frankfurt Goethe-Universität

Frankfurt am Main, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie

Langen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Local Institution - 0293

Düsseldorf, Germany

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

Essen, Germany

Local Institution - 0254

Leipzig, Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, 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, Greece

Agios Savvas Regional Cancer Hospital

Athens, Greece

Local Institution - 0038

Athens, Greece

University General Hospital of Heraklion

Heraklion, Greece

Local Institution - 0337

Mumbai, India

Local Institution - 0131

Mumbai, India

Local Institution - 0134

Nagpur, India

Local Institution - 0352

New Delhi, India

Local Institution - 0266

New Delhi, India

Local Institution - 0206

New Delhi, India

Local Institution - 0125

Chennai, India

Local Institution - 0130

Hyderabad, India

Local Institution - 0133

Varanasi, India

Local Institution - 0186

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Hadassah Medical Center

Jerusalem, Israel

Hillel Yaffe Medical Center

Hadera, Israel

Rambam Health Care Campus

Haifa, Israel

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

Bologna, Italy

Cro-Irccs

Aviano, Italy

Ospedale San Martino

Genoa, Italy

Ospedale "Felice Lotti" Di Pontedera

Pontedera, Italy

Nuovo Ospedale di Prato-S.Stefano

Prato, Italy

Istituto Europeo di Oncologia IRCCS

Milan, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Italy

Istituto Oncologico Veneto IRCCS

Padova, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, Italy

Local Institution - 0236

Nagoya, Japan

Local Institution - 0230

Chiba, Japan

Local Institution - 0240

Matsuyama, Japan

Local Institution - 0226

Otashi, Japan

Local Institution - 0222

Sapporo, Japan

Local Institution - 0232

Kanazawa, Japan

Local Institution - 0234

Isehara, Japan

Local Institution - 0237

Yokohama, Japan

Local Institution - 0246

Tsu, Japan

Local Institution - 0223

Sendai, Japan

Local Institution - 0238

Suita, Japan

Local Institution - 0227

Hidaka, Japan

Local Institution - 0224

Ina-machi, Japan

Local Institution - 0231

Bunkyo-ku, Japan

Local Institution - 0229

Chuo-ku, Japan

Local Institution - 0228

Koto, Japan

Local Institution - 0245

Shinagawa, Japan

Local Institution - 0233

Shinjuku-ku, 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, Mexico

Local Institution - 0264

Tijuana, Mexico

Local Institution - 0178

Guadalajara, Mexico

Local Institution - 0329

Mexico City, Mexico

Local Institution - 0175

Monterrey, Mexico

Local Institution - 0176

Monterrey, Mexico

Local Institution - 0355

Monterrey, Mexico

Local Institution - 0173

Oaxaca City, Mexico

Local Institution - 0179

Mérida, Mexico

Local Institution - 0174

Chihuahua City, Mexico

AIDPORT Sp. z o.o.

Skórzewo, Poland

Local Institution - 0074

Biała Podlaska, Poland

Local Institution - 0072

Warsaw, Poland

Mazowiecki Szpital Onkologiczny

Warsaw, Poland

Local Institution - 0076

Opole, Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland

Instituto Português de Oncologia de Lisboa Francisco Gentil

Lisbon, Portugal

Local Institution - 0106

Lisbon, Portugal

Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria

Lisbon, 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, Romania

Local Institution - 0213

Bucharest, Romania

SC Radiotherapy Center Cluj SRL

Florești, Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Romania

Oncohelp Medical Center

Timișoara, 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, South Africa

Local Institution - 1034

Panorama, South Africa

Local Institution - 0342

Johannesburg, South Africa

Local Institution - 0336

Pretoria, South Africa

Local Institution - 0341

Pretoria, South Africa

Local Institution - 0340

Soweto, South Africa

Local Institution - 0066

Goyang-si, South Korea

Local Institution - 0067

Seongnam, South Korea

Local Institution - 0068

Seoul, South Korea

Local Institution - 0063

Seoul, South Korea

Local Institution - 0071

Seoul, South Korea

Local Institution - 0064

Seoul, South Korea

Local Institution - 0065

Seoul, South Korea

Local Institution - 0069

Daegu, South Korea

CHUAC-Hospital Teresa Herrera

A Coruña, Spain

Hospital General Universitario de Elche

Elche, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Institut Català d'Oncologia - L'Hospitalet

Hospitalet, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Universitario Donostia

Donostia / San Sebastian, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Clinico de Valencia

Valencia, Spain

Hospital Beata María Ana

Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Skånes Universitetssjukhus Malmö

Malmö, Sweden

Capio Saint Görans Sjukhus

Stockholm, Sweden

Akademiska sjukhuset

Uppsala, Sweden

Universitetssjukhuset Örebro

Örebro, Sweden

Universitetssjukhuset i Linköping

Linköping, Sweden

Cantonal Hospital St.Gallen

Sankt Gallen, Switzerland

CHUV (centre hospitalier universitaire vaudois)

Lausanne, 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, United Arab Emirates

Local Institution - 0318

Abu Dhabi, United Arab Emirates

Local Institution - 0322

Al Ain City, United Arab Emirates

Local Institution - 0319

Abu Dhabi, United Arab Emirates

The Royal Cornwall Hospital

Truro, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

Local Institution - 0204

London, United Kingdom

Local Institution - 0171

Belfast, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Local Institution - 0006

Nottingham, United Kingdom

Trial contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

First line of the email MUST contain NCT # and Site #.

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.