Actively Recruiting
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
Led by Daiichi Sankyo · Updated on 2026-04-08
250
Participants Needed
86
Research Sites
195 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated main informed consent form
- Agree to provide a new or archival biopsy from primary or metastatic tumor
- Pathologically confirmed breast cancer that is unresectable and/or metastatic
- Hormone receptor-negative or hormone receptor-positive with documented percentage of positive cells
- Confirmed HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2 IHC 0 status based on ASCO CAP 2018 guidelines
- Never previously HER2-positive (IHC 3+ or IHC 2+/ISH+)
- No prior anti-HER2 therapy in metastatic setting
- Received one to two prior lines of metastatic therapy
- For hormone receptor-positive HER2-low patients: recurrent disease less than 2 years from adjuvant endocrine therapy start, or progression on CDK4/6 inhibitor within 12 months after adjuvant therapy, or progression within 12 months of first-line metastatic CDK4/6 inhibitor
- At least one measurable lesion by CT or MRI
- Brain metastases allowed if small (<2 cm), untreated, asymptomatic, stable, and not needing urgent intervention
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks at screening
- Left ventricular ejection fraction 50% or higher within 28 days before enrollment
- Adequate organ and bone marrow function within 28 days before enrollment
- Adequate treatment washout before enrollment
- Agree to use effective contraception if of reproductive potential
You will not qualify if you...
- Prior treatment with antibody drug conjugate (ADC)
- Uncontrolled or significant cardiovascular disease
- Corrected QT interval prolongation
- History or current interstitial lung disease (ILD)/pneumonitis requiring steroids or suspected ILD not ruled out by imaging
- Spinal cord compression or active central nervous system metastases
- Multiple primary cancers within 3 years except certain treated skin or solid tumors
- History of severe allergic reactions to drug substances or monoclonal antibodies
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Active primary immunodeficiency, uncontrolled HIV infection, or active hepatitis B or C
- Live attenuated vaccine within 30 days before first study drug dose
- Unresolved toxicities from prior cancer therapy above grade 1 or baseline except alopecia
- Pregnant, breastfeeding, or planning pregnancy
- Significant lung diseases
- Autoimmune, connective tissue, or inflammatory disorders
- Prior complete pneumonectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 86 locations
1
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Terminated
2
USF College of Medicine
Tampa, Florida, United States, 33602
Withdrawn
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Beth Israel Lahey Health
Burlington, Massachusetts, United States, 01805
Withdrawn
5
Overlook Medical Center
Summit, New Jersey, United States, 07901
Actively Recruiting
6
Mater Hospital Sydney
North Sydney, New South Wales, Australia, 2065
Terminated
7
Monash Medical Centre Moorabbin
East Bentleigh, Victoria, Australia, 3165
Terminated
8
GenesisCare St Andrews Hospital
Adelaide, Australia, 5000
Terminated
9
Fiona Stanley Hospital
Murdoch, Australia, 6150
Withdrawn
10
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
11
GZA Ziekenhuizen
Antwerp, Belgium, 2610
Actively Recruiting
12
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Actively Recruiting
13
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
14
UZ Leuven
Leuven, Belgium, 3000
Withdrawn
15
Centre Hospitalier Universitaire de Liege Sart-Tilman
Liège, Belgium, 4000
Withdrawn
16
GZA Ziekenhuizen
Wilrijk, Belgium, 2610
Actively Recruiting
17
Centro de Oncologia - Unidade Brasília - Hospital Sírio Libanês
Brasília, Brazil, 71635-610
Actively Recruiting
18
CIONC-Centro Integrado de Oncologia de Curitiba
Curitiba, Brazil, 80810-050
Actively Recruiting
19
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, Brazil, 81520-060
Actively Recruiting
20
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
Florianópolis, Brazil, 88034-000
Actively Recruiting
21
Oncosite - Centro de Pesquisa Clinica e Oncologia
Ijuí, Brazil, 98700-000
Actively Recruiting
22
Fundação Doutor Amaral Carvalho
Jaú, Brazil, 17.210 - 080
Actively Recruiting
23
Instituto de Cancer de Londrina
Londrina, Brazil, 86015-520
Actively Recruiting
24
Hospital das Clínicas FMRP-USP
Riberão Preto, Brazil, 14015-010
Actively Recruiting
25
Hospital Nossa Senhora da Conceicao
Rio Grande, Brazil, 88701-160
Actively Recruiting
26
Ensino e Terapia de Inovação Clínica AMO-ETICA
Salvador, Brazil, 41810-570
Actively Recruiting
27
Catarina Pesquisa Clinica
Santa Catarina, Brazil, 88301-220
Actively Recruiting
28
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, Brazil, 09060-650
Actively Recruiting
29
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
30
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, Brazil, 01246-000
Actively Recruiting
31
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
São Paulo, Brazil, 01317-001
Actively Recruiting
32
Beijing Hospital
Beijing, China, 100006
Actively Recruiting
33
307 Hospital of PLA
Beijing, China, 100161
Actively Recruiting
34
Fujian Cancer Hospital
Fujian, China, 350011
Actively Recruiting
35
Sun Yat sen University Cancer Center
Guangzhou, China, 510060
Actively Recruiting
36
Zhejiang Cancer Hospital
Hangzhou, China, 310022
Actively Recruiting
37
Anhui Provincial Cancer Hospital
Hefei, China, 230031
Actively Recruiting
38
Shandong Cancer Hospital
Jinan, China, 250117
Actively Recruiting
39
Yunnan Cancer Hospital
Kunming, China, 650107
Actively Recruiting
40
Nanchang People's Hospital
Nanchang, China, 330006
Actively Recruiting
41
Jiangxi Cancer Hospital
Nanchang, China, 330029
Actively Recruiting
42
The Affiliated Hospital of Qingdao University
Qingdao, China, 266000
Actively Recruiting
43
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
44
Henan Cancer Hospital
Zhengzhou, China, 450008
Actively Recruiting
45
Cork University Hospital
Cork, Ireland, T12 EC8P
Actively Recruiting
46
St Vincent's University Hospital
Dublin, Ireland, D04 T6F4
Actively Recruiting
47
St James Hospital
Dublin, Ireland, D08 NHY1
Actively Recruiting
48
Beaumont Hospital
Dublin, Ireland, Dublin 9
Actively Recruiting
49
Galway University Hospital
Galway, Ireland, H91 YR71
Actively Recruiting
50
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, Italy, 70124
Actively Recruiting
51
Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS
Bologna, Italy, 40138
Actively Recruiting
52
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genova, Italy, 16132
Actively Recruiting
53
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
54
Humanitas Istituto Clinico Catanese
Misterbianco, Italy, 95045
Actively Recruiting
55
Istituto Nazionale Tumori Fondazione G Pascale
Naples, Italy, 80131
Actively Recruiting
56
IOV - Istituto Oncologico Veneto IRCCS
Padova, Italy, 35128
Actively Recruiting
57
Nuovo Ospedale di Prato
Prato, Italy, 59100
Actively Recruiting
58
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Rome, Italy, 00161
Actively Recruiting
59
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
60
Ospedale Santa Chiara
Trento, Italy, 38123
Actively Recruiting
61
Amsterdam UMC, Locatie VUMC
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
62
Amphia Ziekenhuis Molengracht
Breda, Netherlands, 4818 CK
Actively Recruiting
63
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands, 8934 AD
Actively Recruiting
64
Alrijne Ziekenhuis Leiden
Leiden, Netherlands, 2334
Actively Recruiting
65
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Actively Recruiting
66
Haga Ziekenhuis
The Hague, Netherlands, 2545 AA
Actively Recruiting
67
Elisabeth TweeSteden Ziekenhuis
Tilburg, Netherlands, 5022 GC
Actively Recruiting
68
Bernhoven Uden
Uden, Netherlands, 5406
Actively Recruiting
69
Hospital de Braga
Braga, Portugal, 4710-243
Actively Recruiting
70
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, Portugal, 1099-023
Actively Recruiting
71
Fundação Champalimaud
Lisbon, Portugal, 1400-038
Actively Recruiting
72
Centro Hospitalar de Lisboa Norte E P E Hospital de Santa Maria
Lisbon, Portugal, 1649-028
Actively Recruiting
73
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
74
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain, 08908
Actively Recruiting
75
Hospital Universitario Donostia
Donostia / San Sebastian, Spain, 20014
Actively Recruiting
76
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Actively Recruiting
77
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria, Spain, 35016
Actively Recruiting
78
Hospital Beata Maria Ana
Madrid, Spain, 28007
Actively Recruiting
79
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
80
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain, 28222
Actively Recruiting
81
Hospital General Universitario Morales Meseguer
Murcia, Spain, 30008
Actively Recruiting
82
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
83
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
84
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
85
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
86
Hospital Arnau de Vilanova de Valencia
Valencia, Spain, 46015
Actively Recruiting
Research Team
(
(US Sites) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
(
(Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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