A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)

June 9, 2025 updated by: Daiichi Sankyo

A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1 (DESTINY-Breast01)

Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis
      • Charleroi, Belgium, 6000
        • Grand Hôpital de Charleroi
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • Chu Sart Tilman
      • Mechelen, Belgium, 2800
        • Az Sint-Maarten
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • University of Calgary
  • France
      • Avignon, France, 84918
        • Institut Sainte Catherine
      • Besançon, France, 25030
        • CHU Besancon - Hopital Jean Minjoz
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc
      • Gironde, France, 33075
        • CHU Bordeaux - Hôpital Saint André
      • La Rochelle, France, 17019
        • CH de la Rochelle - Hopital St Louis
      • Le Mans, France, 72015
        • Clinique Victor Hugo - Centre Jean Bernard
      • Marseille, France, 13915
        • Hopital Nord - CHU Marseille
      • Montpellier, France, 34298
        • Institut régional du Cancer de Montpellier
      • Nantes, France, 44202
        • Centre Catherine de Sienne
      • Paris, France, 75475
        • Hôpital Saint-Louis - Paris
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Rennes, France, 35042
        • CRLCC Eugene Marquis
      • Saint-Mandé, France, 94160
        • Hôpital d'Instruction des Armées BEGIN
      • Strasbourg, France, 67000
        • Centre Paul Strauss
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Italy
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milano, Italy, 20141
        • IEO Istituto Europeo di Oncologia
      • Monza, Italy, 20900
        • Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
      • Rimini, Italy, 47923
        • Ospedale degli Infermi
      • Torrette, Italy, 60020
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
  • Japan
      • Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
      • Fukuoka, Japan, 811-1395
        • NHO Kyushu Cancer Center
      • Kagoshima, Japan, 892-0833
        • Hakuaikai Sagara Hospital
      • Kanagawa, Japan, 241-0815
        • Kanagawa Cancer Center
      • Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Tokyo, Japan, 104-8560
        • St. Luke's International Hospital
      • Tokyo, Japan, 135-8550
        • Cancer Institute Hospital of JFCR
    • Ehime-Ken
      • Matsuyama, Ehime-Ken, Japan, 791-0280
        • Nho Shikoku Cancer Center
    • Tokyo-To
      • Minato-Ku, Tokyo-To, Japan, 105-8470
        • Toranomon Hospital
  • Korea, Republic of
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
      • Goyang-si, Korea, Republic of, 10408
        • National Cancer Center
      • Seongnam-si, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University
  • Spain
      • Badajoz, Spain, 6080
        • Hospital Infanta Cristina
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 8023
        • Hospital Quiron Barcelona
      • Barcelona, Spain, 08908
        • ICO l´Hospitalet - Hospital Duran i Reynals
      • Barcelona, Spain, 08028
        • Hospital Universitari Quiron Dexeus
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28033
        • Md Anderson Cancer Centre
      • Málaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia IVO
  • United Kingdom
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8BQ
        • Derriford Hospital
    • Greater London
      • London, Greater London, United Kingdom, EC1M 6BQ
        • Queen Mary University of London
      • London, Greater London, United Kingdom, NW1 2PG
        • University College London Hospitals
    • Lothian Region
      • Edinburgh, Lothian Region, United Kingdom, EH4 2XU
        • Western General Hospital
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham University Hospitals City Campus
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Urological Institute dba Alaska Clinical Research Center
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology Associates
    • California
      • Los Angeles, California, United States, 90095
        • The Regents of the University of California
      • San Diego, California, United States, 92123
        • Sharp Clinical Oncology Research
      • San Francisco, California, United States, 94115
        • University of California San Francisco
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute, LLC
    • Florida
      • Boca Raton, Florida, United States, 33426
        • Sylvester Comprehensive Cancer Center - Deerfield Beach
      • Hialeah, Florida, United States, 33012
        • Specialist Global Research
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute at Baptist Health, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Straub Medical Center
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Research Foundation
    • Louisiana
      • New Orleans, Louisiana, United States, 70120
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • East Setauket, New York, United States, 11733
        • North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital Cancer Center
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • St Francis Hospital
    • Texas
      • Baytown, Texas, United States, 77521
        • Accurate Clinical Research
      • Dallas, Texas, United States, 75246
        • Texas Oncology, P.A.
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Research Institute
      • Houston, Texas, United States, 77024
        • Texas Oncology - Memorial City
      • Tyler, Texas, United States, 75708
        • The University of Texas Health Science Center at Tyler
      • Tyler, Texas, United States, 75702
        • Texas Oncology, P.A. - Longview
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Medical Center - Everett

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men or women the age of majority in their country

  • Has pathologically documented breast cancer that:

    1. is unresectable or metastatic
    2. has HER2 positive expression confirmed per protocol
  • Has an adequate tumor sample
  • Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Has protocol-defined adequate cardiac, renal and hepatic function
  • Agrees to follow protocol-defined method(s) of contraception

Exclusion Criteria:

  • Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
  • Has a corrected QT interval (QTc) prolongation to > 450 millisecond (ms) in males and > 470 ms in females
  • Has a medical history of clinically significant lung disease
  • Is suspected to have certain other protocol-defined diseases based on imaging at screening period

  • Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:

    1. safety or well-being of the participant or offspring
    2. safety of study staff
    3. analysis of results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DS-8201a Low Dose
T-DM1 resistant/refractory (R/R) patients in the low dose treatment group
Drug: DS-8201a
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as low, medium and high intravenous (IV) doses for Part 1 of the trial. The dose for Part 2 will be determined based on results from Part 1.
Other Names:
  • Experimental product
Experimental: DS-8201a Medium Dose
T-DM1 resistant/refractory (R/R) patients in the medium dose treatment group
Drug: DS-8201a
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as low, medium and high intravenous (IV) doses for Part 1 of the trial. The dose for Part 2 will be determined based on results from Part 1.
Other Names:
  • Experimental product
Experimental: DS-8201a High Dose
T-DM1 resistant/refractory (R/R) patients in the high dose treatment group
Drug: DS-8201a
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as low, medium and high intravenous (IV) doses for Part 1 of the trial. The dose for Part 2 will be determined based on results from Part 1.
Other Names:
  • Experimental product
Other: Exploratory Arm
In Part 2b- Continuation Stage, about 10 T-DM1 Intolerant patients will receive the DS-8201a recommended dose (RD) as an exploratory arm
Drug: DS-8201a
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as low, medium and high intravenous (IV) doses for Part 1 of the trial. The dose for Part 2 will be determined based on results from Part 1.
Other Names:
  • Experimental product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate as Confirmed by Independent Central Review Following Intravenous Administration of 5.4 mg/kg DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Time Frame: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
The number of participants with objective response was assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment, by independent central imaging facility review based on RECIST version 1.1.
at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Time Frame: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
The number of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment. Investigator-assessed objective response rate (ORR) was defined as the proportion of participants who achieved a best overall response of complete response or partial response based on local radiologists/investigators' tumor assessments.
at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Time Frame: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Best overall tumor response was defined as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) by the investigator based on RECIST v1.1. Participants who were non-evaluable (NE) are also reported.
at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Disease Control Rate and Clinical Benefit Rate as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Time Frame: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Number of participants with controlled disease and who received clinical benefit from treatment as assessed by independent central review. DCR was defined as the proportion of participants who achieved a best overall response of complete response, partial response, or stable disease. CBR was defined as the proportion of participants who achieved a best overall response of complete response or partial response or more than 6 months of stable disease.
at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Duration of Response (Complete Response or Partial Response) as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Time Frame: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
The estimated duration of confirmed response (complete response [CR] or partial response [PR]) was assessed by independent central review. Duration of response was defined as the time interval between the date of first documentation of objective response (CR or PR) and the date of the first objective documentation of disease progression or death due to any cause.
at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Progression-Free Survival Estimate As Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Time Frame: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
The point estimate of progression-free survival (PFS) is reported. PFS was defined as the time interval between the date of randomization/registration and the first documentation of disease progression or death due to any cause.
at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Time Frame: Baseline up to Week 6, 12, 18, 24, 30, 36 post dose
Best percent change in sum of diameters of measurable tumors was based on RECIST 1.1. The best percent change was defined as the percent change in the smallest sum of diameters from all post-baseline tumor assessments, taking as reference the baseline sum of diameters.
Baseline up to Week 6, 12, 18, 24, 30, 36 post dose
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
Time Frame: Day 0 to Day 47 post last dose
TEAEs were assessed by severity and seriousness according to unique criteria. Severity described the intensity of an event and was graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening consequences; urgent intervention indicated; and Grade 5: Death related to AE. Serious TEAEs were defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires inpatient hospitalization, or causes prolongation of existing hospitalization.
Day 0 to Day 47 post last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Collaborators

AstraZeneca
Daiichi Sankyo Co., Ltd.

Investigators

  • Study Director: Global Clinical Leader, Daiichi Sankyo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2017

Primary Completion (Actual)

March 21, 2019

Study Completion (Actual)

May 6, 2024

Study Registration Dates

First Submitted

August 10, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 9, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS8201-A-U201
  • 2016-004986-18 (EudraCT Number)
  • JapicCTI-173693(en) (Registry Identifier: JapicCTI)
  • DESTINY-Breast01 (Other Identifier: Daiichi Sankyo and AstraZeneca)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) 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

Studies 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 from 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
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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