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 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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Trastuzumab Deruxtecan

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: (US Sites) Daiichi Sankyo Contact for Clinical Trial Information; Phone Number: 908-992-6400; Email: CTRinfo@dsi.com
• Study Contact Backup: Name: (Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information; Phone Number: +81-3-6225-1111 (M-F 9-5 JST); Email: dsclinicaltrial@daiichisankyo.co.jp

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Terminated
    • Genesiscare St Andrews Hospital
  • Murdoch, Australia, 6150
    • Withdrawn
    • Fiona Stanley Hospital
  • New South Wales
    • North Sydney, New South Wales, Australia, 2065
      • Terminated
      • Mater Hospital Sydney
  • Victoria
    • East Bentleigh, Victoria, Australia, 3165
      • Terminated
      • Monash Medical Centre Moorabbin
• Belgium
  • Anderlecht, Belgium, 1070
    • Recruiting
    • Institut Jules Bordet
    • Contact: Study Coordinator
  • Antwerp, Belgium, 2610
    • Recruiting
    • GZA Ziekenhuizen
    • Contact: Study Coordinator
  • Brussels, Belgium, 1090
    • Recruiting
    • Universitair Ziekenhuis Brussel
    • Contact: Study Coordinator
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-luc
    • Contact: Study Coordinator
  • Leuven, Belgium, 3000
    • Withdrawn
    • UZ Leuven
  • Liège, Belgium, 4000
    • Withdrawn
    • Centre Hospitalier Universitaire de Liege Sart-Tilman
  • Wilrijk, Belgium, 2610
    • Recruiting
    • GZA Ziekenhuizen
    • Contact: Study Coordinator
• Brazil
  • Brasília, Brazil, 71635-610
    • Recruiting
    • Centro de Oncologia - Unidade Brasília - Hospital Sírio Libanês
    • Contact: Study Coordinator
  • Curitiba, Brazil, 80810-050
    • Recruiting
    • CIONC-Centro Integrado de Oncologia de Curitiba
    • Contact: Study Coordinator
  • Curitiba, Brazil, 81520-060
    • Recruiting
    • Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Cancer
    • Contact: Study Coordinator
  • Florianópolis, Brazil, 88034-000
    • Recruiting
    • CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
    • Contact: Study Coordinator
  • Ijuí, Brazil, 98700-000
    • Recruiting
    • Oncosite - Centro de Pesquisa Clinica E Oncologia
    • Contact: Study Coordinator
  • Jaú, Brazil, 17.210 - 080
    • Recruiting
    • Fundação Doutor Amaral Carvalho
    • Contact: Study Coordinator
  • Londrina, Brazil, 86015-520
    • Recruiting
    • Instituto de Câncer de Londrina
    • Contact: Study Coordinator
  • Riberão Preto, Brazil, 14015-010
    • Recruiting
    • Hospital das Clínicas FMRP-USP
    • Contact: Study Coordinator
  • Rio Grande, Brazil, 88701-160
    • Recruiting
    • Hospital Nossa Senhora da Conceicao
    • Contact: Study Coordinator
  • Salvador, Brazil, 41810-570
    • Recruiting
    • Ensino e Terapia de Inovação Clínica AMO-ETICA
    • Contact: Study Coordinator
  • Santa Catarina, Brazil, 88301-220
    • Recruiting
    • Catarina Pesquisa Clinica
    • Contact: Study Coordinator
  • Santo André, Brazil, 09060-650
    • Recruiting
    • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
    • Contact: Study Coordinator
  • São José do Rio Preto, Brazil, 15090-000
    • Recruiting
    • Fundação Faculdade Regional de Medicina de São José do Rio Preto
    • Contact: Study Coordinator
  • São Paulo, Brazil, 01317-001
    • Recruiting
    • Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
    • Contact: Study Coordinator
  • São Paulo, Brazil, 01246-000
    • Recruiting
    • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
    • Contact: Study Coordinator
• China
  • Beijing, China, 100161
    • Recruiting
    • 307 Hospital of PLA
    • Contact: Principal Investigator
  • Beijing, China, 100006
    • Recruiting
    • Beijing Hospital
    • Contact: Study Coordinator
  • Fujian, China, 350011
    • Recruiting
    • Fujian Cancer Hospital
    • Contact: Study Coordinator
  • Guangzhou, China, 510060
    • Recruiting
    • Sun Yat Sen University Cancer Center
    • Contact: Study Coordinator
  • Hangzhou, China, 310022
    • Recruiting
    • Zhejiang Cancer Hospital
    • Contact: Study Coordinator
  • Hefei, China, 230031
    • Recruiting
    • Anhui Provincial Cancer Hospital
    • Contact: Study Coordinator
  • Jinan, China, 250117
    • Recruiting
    • Shandong Cancer Hospital
    • Contact: Study Coordinator
  • Kunming, China, 650107
    • Recruiting
    • Yunnan Cancer Hospital
    • Contact: Study Coordinator
  • Nanchang, China, 330006
    • Recruiting
    • Nanchang People's Hospital
    • Contact: Study Coordinator
  • Nanchang, China, 330029
    • Recruiting
    • Jiangxi Cancer Hospital
    • Contact: Study Coordinator
  • Qingdao, China, 266000
    • Recruiting
    • The affiliated hospital of Qingdao university
    • Contact: Study Coordinator
  • Shanghai, China, 200032
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Principal Investigator
  • Zhengzhou, China, 450008
    • Recruiting
    • Henan Cancer Hospital
    • Contact: Study Coordinator
• Ireland
  • Cork, Ireland, T12 EC8P
    • Recruiting
    • Cork University Hospital
    • Contact: Study Coordinator
  • Dublin, Ireland, D04 T6F4
    • Recruiting
    • St Vincent's University Hospital
    • Contact: Study Coordinator
  • Dublin, Ireland, Dublin 9
    • Recruiting
    • Beaumont Hospital
    • Contact: Principal Investigator
  • Dublin, Ireland, D08 NHY1
    • Recruiting
    • St James Hospital
    • Contact: Principal Investigator
  • Galway, Ireland, H91 YR71
    • Recruiting
    • Galway University Hospital
    • Contact: Study Coordinator
• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
    • Contact: Study Coordinator
  • Bologna, Italy, 40138
    • Recruiting
    • Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS
    • Contact: Study Coordinator
  • Genova, Italy, 16132
    • Recruiting
    • Istituto Nazionale Per La Ricerca Sul Cancro Di Genova
    • Contact: Study Coordinator
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
    • Contact: Study Coordinator
  • Misterbianco, Italy, 95045
    • Recruiting
    • Humanitas Istituto Clinico Catanese
    • Contact: Study Coordinator
  • Naples, Italy, 80131
    • Recruiting
    • Istituto Nazionale Tumori Fondazione G Pascale
    • Contact: Study Coordinator
  • Padova, Italy, 35128
    • Recruiting
    • Iov - Istituto Oncologico Veneto Irccs
    • Contact: Study Coordinator
  • Prato, Italy, 59100
    • Recruiting
    • Nuovo Ospedale di Prato
    • Contact: Study Coordinator
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Contact: Principal Investigator
  • Rome, Italy, 00161
    • Recruiting
    • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
    • Contact: Study Coordinator
  • Trento, Italy, 38123
    • Recruiting
    • Ospedale Santa Chiara
    • Contact: Study Coordinator
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Recruiting
    • Amsterdam UMC, locatie VUmc
    • Contact: Study Coordinator
  • Breda, Netherlands, 4818 CK
    • Recruiting
    • Amphia Ziekenhuis Molengracht
    • Contact: Study Coordinator
  • Leeuwarden, Netherlands, 8934 AD
    • Recruiting
    • Medisch Centrum Leeuwarden
    • Contact: Study Coordinator
  • Leiden, Netherlands, 2334
    • Recruiting
    • Alrijne Ziekenhuis Leiden
    • Contact: Principal Investigator
  • Maastricht, Netherlands, 6229 HX
    • Recruiting
    • Maastricht University Medical Center
    • Contact: Study Coordinator
  • The Hague, Netherlands, 2545 AA
    • Recruiting
    • Haga ziekenhuis
    • Contact: Study Coordinator
  • Tilburg, Netherlands, 5022 GC
    • Recruiting
    • Elisabeth Tweesteden Ziekenhuis
    • Contact: Study Coordinator
  • Uden, Netherlands, 5406
    • Recruiting
    • Bernhoven Uden
    • Contact: Principal Investigator
• Portugal
  • Braga, Portugal, 4710-243
    • Recruiting
    • Hospital de Braga
    • Contact: Study Coordinator
  • Lisbon, Portugal, 1400-038
    • Recruiting
    • Fundacao Champalimaud
    • Contact: Study Coordinator
  • Lisbon, Portugal, 1099-023
    • Recruiting
    • Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
    • Contact: Study Coordinator
  • Lisbon, Portugal, 1649-028
    • Recruiting
    • Centro Hospitalar de Lisboa Norte E P E Hospital de Santa Maria
    • Contact: Study Coordinator
• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital De La Santa Creu I Sant Pau
    • Contact: Study Coordinator
  • Barcelona, Spain, 08908
    • Recruiting
    • ICO l'Hospitalet - Hospital Duran i Reynals
    • Contact: Study Coordinator
  • Donostia / San Sebastian, Spain, 20014
    • Recruiting
    • Hospital Universitario Donostia
    • Contact: Study Coordinator
  • Granada, Spain, 18014
    • Recruiting
    • Hospital Universitario Virgen de Las Nieves
    • Contact: Site Coordinator
  • Las Palmas de Gran Canaria, Spain, 35016
    • Recruiting
    • Complejo Hospitalario Universitario Insular Materno-Infantil
    • Contact: Study Coordinator
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
    • Contact: Site Coordinator
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital Beata María Ana
    • Contact: Study Coordinator
  • Majadahonda, Spain, 28222
    • Recruiting
    • Hospital Universitario Puerta de Hierro Majadahonda
    • Contact: Study Coordinator
  • Murcia, Spain, 30008
    • Recruiting
    • Hospital General Universitario Morales Meseguer
    • Contact: Study Coordinator
  • Pamplona, Spain, 31008
    • Recruiting
    • Clinica Universidad de Navarra
    • Contact: Study Coordinator
  • Santiago de Compostela, Spain, 15706
    • Recruiting
    • Complejo Hospitalario Universitario de Santiago
    • Contact: Site Coordinator
  • Seville, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen Macarena
    • Contact: Study Coordinator
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Universitario de Valencia
    • Contact: Study Coordinator
  • Valencia, Spain, 46015
    • Recruiting
    • Hospital Arnau de Vilanova de Valencia
    • Contact: Study Coordinator
• United States
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Terminated
      • Mount Sinai Medical Center
    • Tampa, Florida, United States, 33602
      • Withdrawn
      • USF College of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Study Coordinator
    • Burlington, Massachusetts, United States, 01805
      • Withdrawn
      • Beth Israel Lahey Health
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Recruiting
      • Overlook Medical Center
      • Contact: Study Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
  • 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:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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 Names: T-DXd; DS-8201a (trastuzumab derextecan); Enhertu®
Experimental: 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.	Drug: 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 Names: T-DXd; DS-8201a (trastuzumab derextecan); Enhertu®
Experimental: 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.	Drug: 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 Names: T-DXd; DS-8201a (trastuzumab derextecan); Enhertu®
Experimental: 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.	Drug: 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 Names: T-DXd; DS-8201a (trastuzumab derextecan); Enhertu®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Until subsequent therapy or death, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Until progression or death, assessed up to 24 months
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.	Until treatment discontinuation or death, up to 24 months
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.	Until progression, assessed up to 24 months
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.	Up to follow up period, up to 24 months
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.	Assessed up to 24 months
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.	Assessed up to 24 months
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.	Assessed up to 24 months
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).	Assessed up to 24 months
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.	Assessed up to 24 months
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.	Assessed up to 24 months
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.	Assessed up to 24 months
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.	Assessed up to 24 months
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.	Assessed up to 24 months
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.	Assessed up to 24 months

Collaborators and Investigators

• Sponsor: Daiichi Sankyo
• Collaborators: AstraZeneca
• Investigators: Study Director: Global Clinical Leader, Daiichi Sankyo

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Enhertu®; Trastuzumab Derextecan; DS8201-a; Anti-HER2-Antibody Drug Conjugate
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Immunoconjugates; trastuzumab deruxtecan
• Other Study ID Numbers: DS8201-0001-CIS-MA; 2023-505616-38-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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/
• IPD Sharing Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No