Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
NCT ID: NCT05950945
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
250 participants
INTERVENTIONAL
2023-12-30
2027-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
NCT04494425
DESTINY Breast Respond HER2-low Europe
NCT05945732
A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
NCT04739761
An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer
NCT05592483
Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)
NCT04784715
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1: HR-negative, HER2-low
Participants with HR-negative HER2-low unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.
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
Cohort 2: HR-negative, HER2 IHC 0
Participants with HR-negative HER2 IHC 0 unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.
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
Cohort 3: HR-positive, HER2-low
Participants with HR-positive HER2-low unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.
Participants must also have recurrent disease \<2 years from the initiation of adjuvant ET or have disease progression on CDK4/6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4/6 inhibitor or have disease progression within the first 12 months of CDK4/6 in the first line metastatic setting.
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
Cohort 4: HR-positive, HER2 IHC 0
Participants with HR-positive HER2 IHC 0 unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must agree to provide a newly obtained or archival baseline biopsy from primary and/or metastatic lesion.
* Pathologically documented Breast Cancer (BC) tumor
* Is unresectable and/or metastatic.
* Is hormone receptor-negative or hormone receptor-positive.
* Must include percentage of positively stained cells to characterize if hormone receptor-positive or -negative.
* Has confirmed HER2 IHC 1+ or IHC 2+/ISH- (HER2-low) status or HER2 IHC 0 status as determined according to ASCO CAP 2018 guidelines1 based on sample collected during Tissue Screening as described above.
* Was never previously HER2-positive (IHC 3+ or IHC 2+/ISH+) on prior pathology testing (per ASCO CAP guidelines).
* Was never previously treated with anti-HER2 therapy in the metastatic setting.
* Has had at least one and up to two prior lines of therapy in the metastatic setting.
* In participants with hormone receptor-positive HER2-low metastatic BC (Cohort 3):
* Has recurrent disease \<2 years from the initiation of adjuvant ET OR
* Has disease progression on CDK4/6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4/6 inhibitor OR
* Has disease progression within the first 12 months of CDK4/6 in the first line metastatic setting
* Presence of at least one measurable lesion based on computed tomography or magnetic resonance imaging.
* Participants with brain metastases are allowed in the study. The brain lesion(s) should be small (\<2 cm), untreated, asymptomatic, not requiring urgent medical intervention, and are asymptomatic and clinically stable.
* Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
* Has a minimum life expectancy of 12 weeks at Screening.
* Has a left ventricular ejection fraction ≥50% within 28 days before enrollment.
* Has adequate organ and bone marrow function within 28 days before enrollment.
* Has adequate treatment washout period before enrollment.
* Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception.
Exclusion Criteria
* Uncontrolled or significant cardiovascular disease.
* Has a corrected QT interval prolongation.
* Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
* Has spinal cord compression or clinically active central nervous system metastases.
* Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral BC.
* Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
* Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
* Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
* Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
* Has history of receiving a live, attenuated vaccine (messenger RNA and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study drug.
* Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.
* Is pregnant or breastfeeding or planning to become pregnant.
* Lung-specific intercurrent clinically significant illnesses.
* Any autoimmune, connective tissue, or inflammatory disorders.
* Prior complete pneumonectomy.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mount Sinai Medical Center
Miami Beach, Florida, United States
USF College of Medicine
Tampa, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Lahey Health
Burlington, Massachusetts, United States
Overlook Medical Center
Summit, New Jersey, United States
Mater Hospital Sydney
North Sydney, New South Wales, Australia
Monash Medical Centre Moorabbin
East Bentleigh, Victoria, 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
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
Padua, , 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
Centro Hospitalar de Lisboa Norte E P E Hospital de Santa Maria
Lisbon, , 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
(US Sites) Daiichi Sankyo Contact for Clinical Trial Information
Role: CONTACT
(Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Site Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Principal Investigator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Site Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Principal Investigator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Principal Investigator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Principal Investigator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Principal Investigator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Principal Investigator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Site Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Site Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Site Coordinator
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-505616-38-00
Identifier Type: OTHER
Identifier Source: secondary_id
DS8201-0001-CIS-MA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.