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AzTrials

Breast CancerPhase 3NCT05950945

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

A Phase 3 study testing Trastuzumab Deruxtecan in people with Breast Cancer, run by Daiichi Sankyo at 88 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab Deruxtecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
88 sitesin 10 countries
Study dates
30 Dec 2023to 1 Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign and date the main informed consent form
  • 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.
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  • 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.

Who cannot join

  • Prior treatment with an antibody drug conjugate (ADC).
  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

88 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

(US Sites) Daiichi Sankyo Contact for Clinical Trial Information contact

908-992-6400

CTRinfo@dsi.com

(Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information contact

+81-3-6225-1111 (M-F 9-5 JST)

dsclinicaltrial@daiichisankyo.co.jp

88 sites in 10 countries

Brazil15 sites, 15 recruiting

  • Centro de Oncologia - Unidade Brasília - Hospital Sírio Libanês

    Brasília, 71635-610

    Study Coordinator

    Recruiting

  • CIONC-Centro Integrado de Oncologia de Curitiba

    Curitiba, 80810-050

    Study Coordinator

    Recruiting

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

    Curitiba, 81520-060

    Study Coordinator

    Recruiting

  • CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

    Florianópolis, 88034-000

    Study Coordinator

    Recruiting

  • Oncosite - Centro de Pesquisa Clinica e Oncologia

    Ijuí, 98700-000

    Study Coordinator

    Recruiting

  • Fundação Doutor Amaral Carvalho

    Jaú, 17.210 - 080

    Study Coordinator

    Recruiting

  • Instituto de Cancer de Londrina

    Londrina, 86015-520

    Study Coordinator

    Recruiting

  • Hospital das Clínicas FMRP-USP

    Riberão Preto, 14015-010

    Study Coordinator

    Recruiting

  • Hospital Nossa Senhora da Conceicao

    Rio Grande, 88701-160

    Study Coordinator

    Recruiting

  • Ensino e Terapia de Inovação Clínica AMO-ETICA

    Salvador, 41810-570

    Study Coordinator

    Recruiting

  • Catarina Pesquisa Clinica

    Santa Catarina, 88301-220

    Study Coordinator

    Recruiting

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André, 09060-650

    Study Coordinator

    Recruiting

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

    São José do Rio Preto, 15090-000

    Study Coordinator

    Recruiting

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

    São Paulo, 01246-000

    Study Coordinator

    Recruiting

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

    São Paulo, 01317-001

    Study Coordinator

    Recruiting

Other trials in Brazil

China14 sites, 11 recruiting

  • Beijing Hospital

    Beijing, 100006

    Study Coordinator

    Recruiting

  • 307 Hospital of PLA

    Beijing, 100161

    Principal Investigator

    Recruiting

  • Fujian Cancer Hospital

    Fujian, 350011

    Study Coordinator

    Recruiting

  • Sun Yat sen University Cancer Center

    Guangzhou, 510060

    Study Coordinator

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Study Coordinator

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, 230031

    Study Coordinator

    Recruiting

  • Shandong Cancer Hospital

    Jinan, 250117

    Study Coordinator

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, 650107

    Withdrawn

  • Nanchang People's Hospital

    Nanchang, 330006

    Study Coordinator

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, 330029

    Study Coordinator

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266000

    Withdrawn

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Principal Investigator

    Recruiting

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

    Xi'an, 710032

    Withdrawn

  • Henan Cancer Hospital

    Zhengzhou, 450008

    Study Coordinator

    Recruiting

Other trials in China

Spain14 sites, 13 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

    Study Coordinator

    Recruiting

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona, 08908

    Study Coordinator

    Recruiting

  • Hospital Universitario Donostia

    Donostia / San Sebastian, 20014

    Withdrawn

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

    Site Coordinator

    Recruiting

  • Complejo Hospitalario Universitario Insular Materno-Infantil

    Las Palmas de Gran Canaria, 35016

    Study Coordinator

    Recruiting

  • Hospital Beata Maria Ana

    Madrid, 28007

    Study Coordinator

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Site Coordinator

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

    Study Coordinator

    Recruiting

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

    Study Coordinator

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona, 31008

    Study Coordinator

    Recruiting

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706

    Site Coordinator

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Study Coordinator

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

    Study Coordinator

    Recruiting

  • Hospital Arnau de Vilanova de Valencia

    Valencia, 46015

    Study Coordinator

    Recruiting

Other trials in Spain

Italy11 sites, 10 recruiting

  • Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

    Bari, 70124

    Withdrawn

  • Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS

    Bologna, 40138

    Study Coordinator

    Recruiting

  • Istituto Nazionale per la Ricerca sul Cancro di Genova

    Genova, 16132

    Study Coordinator

    Recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Study Coordinator

    Recruiting

  • Humanitas Istituto Clinico Catanese

    Misterbianco, 95045

    Study Coordinator

    Recruiting

  • Istituto Nazionale Tumori Fondazione G Pascale

    Naples, 80131

    Study Coordinator

    Recruiting

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, 35128

    Study Coordinator

    Recruiting

  • Nuovo Ospedale di Prato

    Prato, 59100

    Study Coordinator

    Recruiting

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

    Rome, 00161

    Study Coordinator

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168

    Principal Investigator

    Recruiting

  • Ospedale Santa Chiara

    Trento, 38123

    Study Coordinator

    Recruiting

Other trials in Italy

Netherlands8 sites, 8 recruiting

  • Amsterdam UMC, Locatie VUMC

    Amsterdam, 1081 HV

    Study Coordinator

    Recruiting

  • Amphia Ziekenhuis Molengracht

    Breda, 4818 CK

    Study Coordinator

    Recruiting

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

    Study Coordinator

    Recruiting

  • Alrijne Ziekenhuis Leiden

    Leiden, 2334

    Principal Investigator

    Recruiting

  • Maastricht University Medical Center

    Maastricht, 6229 HX

    Study Coordinator

    Recruiting

  • Haga Ziekenhuis

    The Hague, 2545 AA

    Study Coordinator

    Recruiting

  • Elisabeth TweeSteden Ziekenhuis

    Tilburg, 5022 GC

    Study Coordinator

    Recruiting

  • Bernhoven Uden

    Uden, 5406

    Principal Investigator

    Recruiting

Other trials in Netherlands

Belgium7 sites, 2 recruiting

  • Institut Jules Bordet

    Anderlecht, 1070

    Study Coordinator

    Recruiting

  • GZA Ziekenhuizen

    Antwerp, 2610

    Withdrawn

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

    Withdrawn

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

    Withdrawn

  • UZ Leuven

    Leuven, 3000

    Withdrawn

  • Centre Hospitalier Universitaire de Liege Sart-Tilman

    Liège, 4000

    Withdrawn

  • GZA Ziekenhuizen

    Wilrijk, 2610

    Study Coordinator

    Recruiting

Other trials in Belgium

United States5 sites, 2 recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Study Coordinator

    Recruiting

  • Beth Israel Lahey Health

    Burlington, Massachusetts, 01805

    Withdrawn

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

    Terminated

  • Overlook Medical Center

    Summit, New Jersey, 07901

    Study Coordinator

    Recruiting

  • USF College of Medicine

    Tampa, Florida, 33602

    Withdrawn

Other trials in United States

Ireland5 sites, 4 recruiting

  • Cork University Hospital

    Cork, T12 EC8P

    Study Coordinator

    Recruiting

  • St Vincent's University Hospital

    Dublin, D04 T6F4

    Study Coordinator

    Recruiting

  • St James Hospital

    Dublin, D08 NHY1

    Principal Investigator

    Recruiting

  • Beaumont Hospital

    Dublin, Dublin 9

    Principal Investigator

    Recruiting

  • Galway University Hospital

    Galway, H91 YR71

    Withdrawn

Other trials in Ireland

Portugal5 sites, 3 recruiting

  • Hospital de Braga

    Braga, 4710-243

    Study Coordinator

    Recruiting

  • Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

    Lisbon, 1099-023

    Withdrawn

  • Fundação Champalimaud

    Lisbon, 1400-038

    Study Coordinator

    Recruiting

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

    Lisbon, 1649-028

    Study Coordinator

    Recruiting

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

    Withdrawn

Other trials in Portugal

Australia4 sites

  • GenesisCare St Andrews Hospital

    Adelaide, 5000

    Terminated

  • Monash Medical Centre Moorabbin

    East Bentleigh, Victoria, 3165

    Terminated

  • Fiona Stanley Hospital

    Murdoch, 6150

    Withdrawn

  • Mater Hospital Sydney

    North Sydney, New South Wales, 2065

    Terminated

Other trials in Australia

About this study

Official title: A Phase 3b, Multicenter, Global, Interventional, Open-label Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15)

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.

Read the detailed description

The primary endpoint of interest in this study is time to next treatment (TTNT), a measure that will determine how long T-DXd allows patients to derive clinical benefit from the study drug.

Conditions
Breast Cancer
Being tested
Trastuzumab Deruxtecan
Keywords
Trastuzumab Derextecan, Enhertu®, DS8201-a, Breast Cancer, Anti-HER2-Antibody Drug Conjugate
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab DeruxtecanDrug

    Also called T-DXd, DS-8201a (trastuzumab derextecan), Enhertu®

    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 groups in NCT05950945
Study groupRoleWhat they receive
Cohort 1: HR-negative, HER2-lowExperimentalParticipants 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.
Receives: Drug: Trastuzumab Deruxtecan
Cohort 2: HR-negative, HER2 IHC 0ExperimentalParticipants 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.
Receives: Drug: Trastuzumab Deruxtecan
Cohort 3: HR-positive, HER2-lowExperimentalParticipants 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.
Receives: Drug: Trastuzumab Deruxtecan
Cohort 4: HR-positive, HER2 IHC 0ExperimentalParticipants 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.
Receives: Drug: Trastuzumab Deruxtecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time From the Start of T-DXd to Initiation of Subsequent Anticancer Treatment (TTNT)

    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.

    Measured: Until subsequent therapy or death, assessed up to 24 months

Secondary outcomes (14)

  1. Real-World Progression Free Survival (PFS)

    Real-world PFS is defined as time from date of first dose of T-DXd to time of disease progression per investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause.

    Measured: Until progression or death, assessed up to 24 months

  2. Time From Start of T-DXd to Discontinuation of T-DXd or Death (TTD)

    TTD is defined as the time interval from the date of first dose of T-DXd to the date of discontinuation of T-DXd or death due to any cause.

    Measured: Until treatment discontinuation or death, up to 24 months

  3. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to the investigator and per RECIST version 1.1 criteria.

    Measured: Until progression, assessed up to 24 months

  4. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    TEAEs are graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after initiating the study drug until 47 days after the last dose of the study drug.

    Measured: Up to follow up period, up to 24 months

  5. Mean Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC-QLQ)-C30 Score

    Change from baseline in the EORTC-QLQ-C30 scale scores range from 0-100. For functioning and global health status/ QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.

    Measured: Assessed up to 24 months

  6. Mean Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC-QLQ)-BR45 Score

    Change from baseline in the EORTC QLQ-BR45 scale scores range from 0-100. For functioning and global health status/ QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.

    Measured: Assessed up to 24 months

  7. Time to First and Definitive Deterioration in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC-QLQ) Scales

    Time to first and definitive deterioration in EORTC-QLQ scales. Scale scores range from 0-100. For functioning and global health status/ QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.

    Measured: Assessed up to 24 months

  8. Mean Change from Baseline in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L)

    Change from baseline in EQ-5D-5L. The EQ-5D-5L is a health-related QoL questionnaire based on five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension contains five levels: no problems, slight, moderate, severe, and extreme problems. The EQ-5D-5L results can be converted into a single utility value. Utility values range from 0 to 1, with 1 corresponding to perfect health and 0 corresponding to a health status equivalent to death. In addition, participants can provide an overall rating of their current health status using a visual analog scale ranging from 0 (worse) to 100 (better).

    Measured: Assessed up to 24 months

  9. Mean Change From Baseline in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) Index Score

    Change from baseline in EQ-5D-5L index score. The EQ-5D-5L index score ranges from less than 0 (worse) to 1 (better), with higher scores representing a better health status.

    Measured: Assessed up to 24 months

  10. Mean Change From Baseline in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS)

    Change from baseline in EQ-5D-5L VAS. The EQ-5D-5L VAS ranging from 0 (worse) to 100 (better) is used to assess an overall rating of participant's current health status. Higher scores indicate better clinical outcomes.

    Measured: Assessed up to 24 months

  11. Time to First and Definitive Deterioration in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS)

    Time to first and definitive deterioration in EQ-5D-5L VAS. The EQ-5D-5L VAS ranging from 0 (worse) to 100 (better) is used to assess an overall rating of participant's current health status. Higher scores indicate better clinical outcomes.

    Measured: Assessed up to 24 months

  12. Patient's Global Impression of Change (PGI-C) Response

    The PGI-C is a single-item questionnaire asking for the participant's overall impression of changes in clinical condition from baseline (prior to study drug initiation), where 1 is "Normal" and 7 is "Severely ill". Lower scores indicate better clinical outcome.

    Measured: Assessed up to 24 months

  13. Patient's Global Impression of Severity (PGI-S) Response

    The PGI-S is a single-item questionnaire asking for the subject's overall impression of symptoms assessed over the past week, where 1 is "Normal" and 4 is "Severe". Lower scores indicate better clinical outcome.

    Measured: Assessed up to 24 months

  14. Patient's Global Impression of Treatment Tolerability (PGI-TT) Response

    The PGI-TT is a single-item questionnaire asking for the subject's overall impression of treatment tolerability over the past week, where 1 is "Not at all" and 5 is "Very much". Higher scores indicate a worse outcome.

    Measured: Assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2023
  2. Study start30 Dec 2023
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05950945
Sponsor's protocol ID
DS8201-0001-CIS-MA
Other IDs
2023-505616-38-00, 2023
Status last verified
Jun 2026
First submitted
22 May 2023
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

  • Yaziji H, Hornick JL, Troxell ML. The Suitability of Repurposed, Legacy HER2 Immunohistochemistry Assays for the Detection of HER2 Low and Ultralow Expression: Current Limitations and Potential Considerations. Appl Immunohistochem Mol Morphol. 2026 Jan 1;34(1):1-4. doi: 10.1097/PAI.0000000000001296. Epub 2025 Dec 4. No abstract available.

    PubMed 41342740

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab Deruxtecan in people with Breast Cancer, run by Daiichi Sankyo at 88 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in Brazil, China, Spain, Italy, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact (US Sites) Daiichi Sankyo Contact for Clinical Trial Information (908-992-6400, CTRinfo@dsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From the Start of T-DXd to Initiation of Subsequent Anticancer Treatment (TTNT) (time frame: Until subsequent therapy or death, assessed up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05950945, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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