New hope for Hard-to-Treat breast cancer: drug targets even low HER2 levels

NCT ID NCT05950945

Recruiting now Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing trastuzumab deruxtecan (T-DXd), a drug that delivers chemotherapy directly to cancer cells with a specific marker (HER2). It includes 250 people with advanced breast cancer that has low or even no HER2, which is often harder to treat. Participants receive the drug every three weeks, and researchers will track how long it takes before they need a different treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: trastuzumab deruxtecan (T-DXd, Enhertu)
What this could lead to: If successful, this could provide a new treatment option for people with advanced breast cancer that has low or no HER2 protein, potentially delaying the need for other therapies.
What could go wrong: This is an open-label study without a placebo group, so results may be less definitive. Side effects from T-DXd can include lung inflammation, nausea, and low blood counts.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST CANCER

Contacts and locations

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307 Hospital of PLA
RECRUITING

Beijing, 100161, China

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Alrijne Ziekenhuis Leiden
RECRUITING

Leiden, 2334, Netherlands

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Amphia Ziekenhuis Molengracht
RECRUITING

Breda, 4818 CK, Netherlands

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Amsterdam UMC, Locatie VUMC
RECRUITING

Amsterdam, 1081 HV, Netherlands

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Anhui Provincial Cancer Hospital
RECRUITING

Hefei, 230031, China

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Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS
RECRUITING

Bologna, 40138, Italy

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

Rome, 00161, Italy

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Beaumont Hospital
RECRUITING

Dublin, Dublin 9, Ireland

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Beijing Hospital
RECRUITING

Beijing, 100006, China

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Bernhoven Uden
RECRUITING

Uden, 5406, Netherlands

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Beth Israel Lahey Health
WITHDRAWN

Burlington, Massachusetts, 01805, United States
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
RECRUITING

Santo André, 09060-650, Brazil

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CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
RECRUITING

Florianópolis, 88034-000, Brazil

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CIONC-Centro Integrado de Oncologia de Curitiba
RECRUITING

Curitiba, 80810-050, Brazil

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Catarina Pesquisa Clinica
RECRUITING

Santa Catarina, 88301-220, Brazil

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Centre Hospitalier Universitaire de Liege Sart-Tilman
WITHDRAWN

Liège, 4000, Belgium
Centro Hospitalar de Lisboa Norte E P E Hospital de Santa Maria
RECRUITING

Lisbon, 1649-028, Portugal

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Centro de Oncologia - Unidade Brasília - Hospital Sírio Libanês
RECRUITING

Brasília, 71635-610, Brazil

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Clinica Universidad de Navarra
RECRUITING

Pamplona, 31008, Spain

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Cliniques Universitaires Saint-Luc
WITHDRAWN

Brussels, 1200, Belgium
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
RECRUITING

São Paulo, 01317-001, Brazil

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Complejo Hospitalario Universitario Insular Materno-Infantil
RECRUITING

Las Palmas de Gran Canaria, 35016, Spain

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Complejo Hospitalario Universitario de Santiago
RECRUITING

Santiago de Compostela, 15706, Spain

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Cork University Hospital
RECRUITING

Cork, T12 EC8P, Ireland

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Dana-Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States

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Elisabeth TweeSteden Ziekenhuis
RECRUITING

Tilburg, 5022 GC, Netherlands

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Ensino e Terapia de Inovação Clínica AMO-ETICA
RECRUITING

Salvador, 41810-570, Brazil

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Fiona Stanley Hospital
WITHDRAWN

Murdoch, 6150, Australia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING

Rome, 00168, Italy

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Fudan University Shanghai Cancer Center
RECRUITING

Shanghai, 200032, China

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Fujian Cancer Hospital
RECRUITING

Fujian, 350011, China

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Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
RECRUITING

São José do Rio Preto, 15090-000, Brazil

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Fundação Champalimaud
RECRUITING

Lisbon, 1400-038, Portugal

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Fundação Doutor Amaral Carvalho
RECRUITING

Jaú, 17.210 - 080, Brazil

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GZA Ziekenhuizen
WITHDRAWN

Antwerp, 2610, Belgium
GZA Ziekenhuizen
RECRUITING

Wilrijk, 2610, Belgium

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Galway University Hospital
WITHDRAWN

Galway, H91 YR71, Ireland
GenesisCare St Andrews Hospital
TERMINATED

Adelaide, 5000, Australia
Haga Ziekenhuis
RECRUITING

The Hague, 2545 AA, Netherlands

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Henan Cancer Hospital
RECRUITING

Zhengzhou, 450008, China

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Hospital Arnau de Vilanova de Valencia
RECRUITING

Valencia, 46015, Spain

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Hospital Beata Maria Ana
RECRUITING

Madrid, 28007, Spain

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Hospital Clinico Universitario de Valencia
RECRUITING

Valencia, 46010, Spain

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Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
RECRUITING

Curitiba, 81520-060, Brazil

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Hospital General Universitario Morales Meseguer
RECRUITING

Murcia, 30008, Spain

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Hospital Nossa Senhora da Conceicao
RECRUITING

Rio Grande, 88701-160, Brazil

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Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain

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Hospital Universitario Donostia
WITHDRAWN

Donostia / San Sebastian, 20014, Spain
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING

Majadahonda, 28222, Spain

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Hospital Universitario Virgen Macarena
RECRUITING

Seville, 41009, Spain

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Hospital Universitario Virgen de las Nieves
RECRUITING

Granada, 18014, Spain

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Hospital das Clínicas FMRP-USP
RECRUITING

Riberão Preto, 14015-010, Brazil

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Hospital de Braga
RECRUITING

Braga, 4710-243, Portugal

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Hospital de la Santa Creu i Sant Pau
RECRUITING

Barcelona, 08025, Spain

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Humanitas Istituto Clinico Catanese
RECRUITING

Misterbianco, 95045, Italy

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

São Paulo, 01246-000, Brazil

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ICO l'Hospitalet - Hospital Duran i Reynals
RECRUITING

Barcelona, 08908, Spain

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IOV - Istituto Oncologico Veneto IRCCS
RECRUITING

Padova, 35128, Italy

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Institut Jules Bordet
RECRUITING

Anderlecht, 1070, Belgium

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Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
WITHDRAWN

Lisbon, 1099-023, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
WITHDRAWN

Porto, 4200-072, Portugal
Instituto de Cancer de Londrina
RECRUITING

Londrina, 86015-520, Brazil

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Istituto Nazionale Tumori Fondazione G Pascale
RECRUITING

Naples, 80131, Italy

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Istituto Nazionale per la Ricerca sul Cancro di Genova
RECRUITING

Genova, 16132, Italy

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Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
WITHDRAWN

Bari, 70124, Italy
Jiangxi Cancer Hospital
RECRUITING

Nanchang, 330029, China

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Maastricht University Medical Center
RECRUITING

Maastricht, 6229 HX, Netherlands

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Mater Hospital Sydney
TERMINATED

North Sydney, New South Wales, 2065, Australia
Medisch Centrum Leeuwarden
RECRUITING

Leeuwarden, 8934 AD, Netherlands

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Monash Medical Centre Moorabbin
TERMINATED

East Bentleigh, Victoria, 3165, Australia
Mount Sinai Medical Center
TERMINATED

Miami Beach, Florida, 33140, United States
Nanchang People's Hospital
RECRUITING

Nanchang, 330006, China

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Nuovo Ospedale di Prato
RECRUITING

Prato, 59100, Italy

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Oncosite - Centro de Pesquisa Clinica e Oncologia
RECRUITING

Ijuí, 98700-000, Brazil

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Ospedale San Raffaele
RECRUITING

Milan, 20132, Italy

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Ospedale Santa Chiara
RECRUITING

Trento, 38123, Italy

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Overlook Medical Center
RECRUITING

Summit, New Jersey, 07901, United States

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Shandong Cancer Hospital
RECRUITING

Jinan, 250117, China

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St James Hospital
RECRUITING

Dublin, D08 NHY1, Ireland

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St Vincent's University Hospital
RECRUITING

Dublin, D04 T6F4, Ireland

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Sun Yat sen University Cancer Center
RECRUITING

Guangzhou, 510060, China

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The Affiliated Hospital of Qingdao University
WITHDRAWN

Qingdao, 266000, China
USF College of Medicine
WITHDRAWN

Tampa, Florida, 33602, United States
UZ Leuven
WITHDRAWN

Leuven, 3000, Belgium
Universitair Ziekenhuis Brussel
WITHDRAWN

Brussels, 1090, Belgium
Xijing Hospital (The First Affiliated Hospital of the Air Force Medical University)
WITHDRAWN

Xi'an, 710032, China
Yunnan Cancer Hospital
WITHDRAWN

Kunming, 650107, China
Zhejiang Cancer Hospital
RECRUITING

Hangzhou, 310022, China

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