RecruitingPhase IIIEN original

Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

⚠️

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

This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjent wyraża zgodę na udział w badaniu i podpisuje formularz.
  • Dostarczenie próbki guza raka piersi do badań (nowej lub archiwalnej).
  • Rak piersi: nieoperacyjny lub z przerzutami.
  • Rak piersi: niski poziom HER2 (IHC 1+ lub IHC 2+/ISH-) lub brak HER2 (IHC 0).
  • Rak piersi: nigdy nie był zdiagnozowany jako HER2-pozytywny (IHC 3+ lub IHC 2+/ISH+).
  • Rak piersi: nieleczony lekami anty-HER2 w leczeniu przerzutów.
  • Pacjent otrzymał dotychczas od jednej do dwóch linii leczenia przerzutów.
  • Obecność co najmniej jednej widocznej zmiany (nowotworowej) na badaniach obrazowych.

✗ Disqualifies

  • Pacjent był wcześniej leczony terapią anty-HER2 w przypadku przerzutów.
  • Pacjent miał guzy raka piersi z wysokim poziomem HER2 (IHC 3+ lub IHC 2+/ISH+).
  • Pacjent ma zmiany przerzutowe w mózgu, które wymagają pilnego leczenia lub nie są stabilne.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 12, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (88)

Mount Sinai Medical Center

Miami Beach, United States

USF College of Medicine

Tampa, United States

Dana-Farber Cancer Institute

Boston, United States

Beth Israel Lahey Health

Burlington, United States

Overlook Medical Center

Summit, United States

Mater Hospital Sydney

North Sydney, Australia

Monash Medical Centre Moorabbin

East Bentleigh, Australia

GenesisCare St Andrews Hospital

Adelaide, Australia

Fiona Stanley Hospital

Murdoch, Australia

Institut Jules Bordet

Anderlecht, Belgium

GZA Ziekenhuizen

Antwerp, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Centre Hospitalier Universitaire de Liege Sart-Tilman

Liège, Belgium

GZA Ziekenhuizen

Wilrijk, Belgium

Centro de Oncologia - Unidade Brasília - Hospital Sírio Libanês

Brasília, Brazil

CIONC-Centro Integrado de Oncologia de Curitiba

Curitiba, Brazil

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

Curitiba, Brazil

CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

Florianópolis, Brazil

Oncosite - Centro de Pesquisa Clinica e Oncologia

Ijuí, Brazil

Fundação Doutor Amaral Carvalho

Jaú, Brazil

Instituto de Cancer de Londrina

Londrina, Brazil

Hospital das Clínicas FMRP-USP

Riberão Preto, Brazil

Hospital Nossa Senhora da Conceicao

Rio Grande, Brazil

Ensino e Terapia de Inovação Clínica AMO-ETICA

Salvador, Brazil

Catarina Pesquisa Clinica

Santa Catarina, Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, Brazil

ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

São Paulo, Brazil

Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda

São Paulo, Brazil

Beijing Hospital

Beijing, China

307 Hospital of PLA

Beijing, China

Fujian Cancer Hospital

Fujian, China

Sun Yat sen University Cancer Center

Guangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Anhui Provincial Cancer Hospital

Hefei, China

Shandong Cancer Hospital

Jinan, China

Yunnan Cancer Hospital

Kunming, China

Nanchang People's Hospital

Nanchang, China

Jiangxi Cancer Hospital

Nanchang, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Fudan University Shanghai Cancer Center

Shanghai, China

Xijing Hospital (The First Affiliated Hospital of the Air Force Medical University)

Xi'an, China

Henan Cancer Hospital

Zhengzhou, China

Cork University Hospital

Cork, Ireland

St Vincent's University Hospital

Dublin, Ireland

St James Hospital

Dublin, Ireland

Beaumont Hospital

Dublin, Ireland

Galway University Hospital

Galway, Ireland

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

Bari, Italy

Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS

Bologna, Italy

Istituto Nazionale per la Ricerca sul Cancro di Genova

Genova, Italy

Ospedale San Raffaele

Milan, Italy

Humanitas Istituto Clinico Catanese

Misterbianco, Italy

Istituto Nazionale Tumori Fondazione G Pascale

Naples, Italy

IOV - Istituto Oncologico Veneto IRCCS

Padova, Italy

Nuovo Ospedale di Prato

Prato, Italy

Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

Rome, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Ospedale Santa Chiara

Trento, Italy

Amsterdam UMC, Locatie VUMC

Amsterdam, Netherlands

Amphia Ziekenhuis Molengracht

Breda, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Alrijne Ziekenhuis Leiden

Leiden, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Haga Ziekenhuis

The Hague, Netherlands

Elisabeth TweeSteden Ziekenhuis

Tilburg, Netherlands

Bernhoven Uden

Uden, Netherlands

Hospital de Braga

Braga, Portugal

Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

Lisbon, Portugal

Fundação Champalimaud

Lisbon, Portugal

Centro Hospitalar de Lisboa Norte E P E Hospital de Santa Maria

Lisbon, Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Porto, Portugal

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, Spain

Hospital Universitario Donostia

Donostia / San Sebastian, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Complejo Hospitalario Universitario Insular Materno-Infantil

Las Palmas de Gran Canaria, Spain

Hospital Beata Maria Ana

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Hospital General Universitario Morales Meseguer

Murcia, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital Arnau de Vilanova de Valencia

Valencia, Spain

Trial contact

(US Sites) Daiichi Sankyo Contact for Clinical Trial Information

(Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information

Contact information from ClinicalTrials.gov. Contact in English.

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