Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Trastuzumab Deruxtecan: Intravenous administration, 5.4 mg/kg on Day 1 of each 21-day cycle until radiographic disease progression as assessed by the investigator, unacceptable toxicity, other discontinuation criteria are met, or 2 years after first dose of study drug
Study summary
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.
Eligibility
Primary outcome measure(s)
- Time From the Start of T-DXd to Initiation of Subsequent Anticancer Treatment (TTNT) — Until subsequent therapy or death, assessed up to 24 months
TTNT is defined as the time interval from the date of first dose of T-DXd to the initiation of the next anticancer treatment or death due to any cause.
Trial sites (88)
| Facility | City | Region | Status |
|---|---|---|---|
| Mount Sinai Medical Center | Miami Beach | Florida | Terminated |
| USF College of Medicine | Tampa | Florida | Withdrawn |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Beth Israel Lahey Health | Burlington | Massachusetts | Withdrawn |
| Overlook Medical Center | Summit | New Jersey | Recruiting |
| Mater Hospital Sydney | North Sydney | New South Wales | Terminated |
| Monash Medical Centre Moorabbin | East Bentleigh | Victoria | Terminated |
| GenesisCare St Andrews Hospital | Adelaide | Australia | Terminated |
| Fiona Stanley Hospital | Murdoch | Australia | Withdrawn |
| Institut Jules Bordet | Anderlecht | Belgium | Recruiting |
| GZA Ziekenhuizen | Antwerp | Belgium | Withdrawn |
| Universitair Ziekenhuis Brussel | Brussels | Belgium | Withdrawn |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | Withdrawn |
| UZ Leuven | Leuven | Belgium | Withdrawn |
| Centre Hospitalier Universitaire de Liege Sart-Tilman | Liège | Belgium | Withdrawn |
| GZA Ziekenhuizen | Wilrijk | Belgium | Recruiting |
| Centro de Oncologia - Unidade Brasília - Hospital Sírio Libanês | Brasília | Brazil | Recruiting |
| CIONC-Centro Integrado de Oncologia de Curitiba | Curitiba | Brazil | Recruiting |
| Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer | Curitiba | Brazil | Recruiting |
| CEPON - Centro de Pesquisas Oncológicas de Santa Catarina | Florianópolis | Brazil | Recruiting |
| Oncosite - Centro de Pesquisa Clinica e Oncologia | Ijuí | Brazil | Recruiting |
| Fundação Doutor Amaral Carvalho | Jaú | Brazil | Recruiting |
| Instituto de Cancer de Londrina | Londrina | Brazil | Recruiting |
| Hospital das Clínicas FMRP-USP | Riberão Preto | Brazil | Recruiting |
| Hospital Nossa Senhora da Conceicao | Rio Grande | Brazil | Recruiting |
| Ensino e Terapia de Inovação Clínica AMO-ETICA | Salvador | Brazil | Recruiting |
| Catarina Pesquisa Clinica | Santa Catarina | Brazil | Recruiting |
| CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia | Santo André | Brazil | Recruiting |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto | São José do Rio Preto | Brazil | Recruiting |
| ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira | São Paulo | Brazil | Recruiting |
| Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda | São Paulo | Brazil | Recruiting |
| Beijing Hospital | Beijing | China | Recruiting |
| 307 Hospital of PLA | Beijing | China | Recruiting |
| Fujian Cancer Hospital | Fujian | China | Recruiting |
| Sun Yat sen University Cancer Center | Guangzhou | China | Recruiting |
| Zhejiang Cancer Hospital | Hangzhou | China | Recruiting |
| Anhui Provincial Cancer Hospital | Hefei | China | Recruiting |
| Shandong Cancer Hospital | Jinan | China | Recruiting |
| Yunnan Cancer Hospital | Kunming | China | Withdrawn |
| Nanchang People's Hospital | Nanchang | China | Recruiting |
+ 48 more sites — see the full list on the official registry below.
On this site
📄 Enhertu (trastuzumab deruxtecan) drug profile →More Daiichi Sankyo trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05950945 on ClinicalTrials.gov ↗ ← All trials in Italy