Study Stopped
The last participant was transitioned to alternative study.
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
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)
4 other identifiers
interventional
253
9 countries
99
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Aug 2017
Longer than P75 for phase_2 breast-cancer
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2017
CompletedFirst Posted
Study publicly available on registry
August 14, 2017
CompletedStudy Start
First participant enrolled
August 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2019
CompletedResults Posted
Study results publicly available
February 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2024
CompletedJune 26, 2025
June 1, 2025
1.6 years
August 10, 2017
January 17, 2020
June 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
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 Outcomes (7)
Objective Response Rate as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
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)
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)
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)
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)
at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
- +2 more secondary outcomes
Study Arms (4)
DS-8201a Low Dose
EXPERIMENTALT-DM1 resistant/refractory (R/R) patients in the low dose treatment group
DS-8201a Medium Dose
EXPERIMENTALT-DM1 resistant/refractory (R/R) patients in the medium dose treatment group
DS-8201a High Dose
EXPERIMENTALT-DM1 resistant/refractory (R/R) patients in the high dose treatment group
Exploratory Arm
OTHERIn Part 2b- Continuation Stage, about 10 T-DM1 Intolerant patients will receive the DS-8201a recommended dose (RD) as an exploratory arm
Interventions
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.
Eligibility Criteria
You may qualify if:
- Men or women the age of majority in their country
- Has pathologically documented breast cancer that:
- is unresectable or metastatic
- 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
You may not qualify if:
- 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:
- safety or well-being of the participant or offspring
- safety of study staff
- analysis of results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- AstraZenecacollaborator
- Daiichi Sankyo Co., Ltd.collaborator
Study Sites (99)
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, 99508, United States
Arizona Oncology Associates
Tucson, Arizona, 85704, United States
The Regents of the University of California
Los Angeles, California, 90095, United States
Sharp Clinical Oncology Research
San Diego, California, 92123, United States
University of California San Francisco
San Francisco, California, 94115, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
Innovative Clinical Research Institute, LLC
Whittier, California, 90603, United States
Sylvester Comprehensive Cancer Center - Deerfield Beach
Boca Raton, Florida, 33426, United States
Specialist Global Research
Hialeah, Florida, 33012, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176, United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318, United States
Straub Medical Center
Honolulu, Hawaii, 96813, United States
University of Hawaii
Honolulu, Hawaii, 96813, United States
Norton Healthcare
Louisville, Kentucky, 40202, United States
University of Louisville Research Foundation
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70120, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists
East Setauket, New York, 11733, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Aultman Hospital Cancer Center
Canton, Ohio, 44710, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
St Francis Hospital
Greenville, South Carolina, 29601, United States
Accurate Clinical Research
Baytown, Texas, 77521, United States
Texas Oncology, P.A.
Dallas, Texas, 75246, United States
Texas Oncology - Memorial City
Houston, Texas, 77024, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
Texas Oncology, P.A. - Longview
Tyler, Texas, 75702, United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Providence Regional Medical Center - Everett
Everett, Washington, 98201, United States
Imeldaziekenhuis
Bonheiden, 2820, Belgium
Grand Hôpital de Charleroi
Charleroi, 6000, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU Sart Tilman
Liège, 4000, Belgium
AZ Sint-Maarten
Mechelen, 2800, Belgium
University of Calgary
Calgary, Alberta, T2N 4N2, Canada
Institut Sainte Catherine
Avignon, 84918, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, 25030, France
Centre Georges François Leclerc
Dijon, 21079, France
CHU Bordeaux - Hôpital Saint André
Gironde, 33075, France
CH de la Rochelle - Hopital St Louis
La Rochelle, 17019, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, 72015, France
Hôpital Nord - CHU Marseille
Marseille, 13915, France
Institut Régional du Cancer de Montpellier
Montpellier, 34298, France
Centre Catherine de Sienne
Nantes, 44202, France
Hôpital Saint-Louis - Paris
Paris, 75475, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CRLCC Eugene Marquis
Rennes, 35042, France
Hôpital d'Instruction des Armees Begin
Saint-Mandé, 94160, France
Centre Paul Strauss
Strasbourg, 67000, France
Institut Gustave Roussy
Villejuif, 94805, France
Ospedale San Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
IEO Istituto Europeo di Oncologia
Milan, 20141, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza, 20900, Italy
Ospedale degli Infermi
Rimini, 47923, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Torrette, 60020, Italy
NHO Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Toranomon Hospital
Minatoku, Tokyo-To, 105-8470, Japan
Aichi Cancer Center Hospital
Aichi, 464-8681, Japan
National Cancer Center Hospital East
Chiba, 277-8577, Japan
NHO Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Hakuaikai Sagara Hospital
Kagoshima, 892-0833, Japan
Kanagawa Cancer Center
Kanagawa, 241-0815, Japan
Kindai University Hospital
Osaka, 589-8511, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
St. Luke's International Hospital
Tokyo, 104-8560, Japan
Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Infanta Cristina
Badajoz, 6080, Spain
Hospital Universitari Quiron Dexeus
Barcelona, 08028, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
ICO l´Hospitalet - Hospital Duran i Reynals
Barcelona, 08908, Spain
Hospital Quiron Barcelona
Barcelona, 8023, Spain
MD Anderson Cancer Centre
Madrid, 28033, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Instituto Valenciano de Oncologia IVO
Valencia, 46009, Spain
Derriford Hospital
Plymouth, Devon, PL6 8BQ, United Kingdom
Queen Mary University of London
London, Greater London, EC1M 6BQ, United Kingdom
University College London Hospitals
London, Greater London, NW1 2PG, United Kingdom
Western General Hospital
Edinburgh, Lothian Region, EH4 2XU, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Related Publications (6)
Dunton K, Vondeling G, Hancock E, Petrou M, Burn O, Paine A. Methods for Estimating Long-Term Outcomes for Trastuzumab Deruxtecan in HER2-Positive Unresectable or Metastatic Breast Cancer After Two or More Anti-HER2 Therapies. Target Oncol. 2022 Nov;17(6):655-663. doi: 10.1007/s11523-022-00923-9. Epub 2022 Nov 7.
PMID: 36342619DERIVEDRugo HS, Bianchini G, Cortes J, Henning JW, Untch M. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open. 2022 Aug;7(4):100553. doi: 10.1016/j.esmoop.2022.100553. Epub 2022 Aug 11.
PMID: 35964548DERIVEDBardia A, Harnden K, Mauro L, Pennisi A, Armitage M, Soliman H. Clinical Practices and Institutional Protocols on Prophylaxis, Monitoring, and Management of Selected Adverse Events Associated with Trastuzumab Deruxtecan. Oncologist. 2022 Aug 5;27(8):637-645. doi: 10.1093/oncolo/oyac107.
PMID: 35642907DERIVEDModi S. Trastuzumab deruxtecan in previously treated HER2-positive metastatic breast cancer: Plain language summary of the DESTINY-Breast01 study. Future Oncol. 2021 Sep 1;17(26):3415-3423. doi: 10.2217/fon-2021-0427. Epub 2021 Jul 15.
PMID: 34263665DERIVEDYin O, Iwata H, Lin CC, Tamura K, Watanabe J, Wada R, Kastrissios H, AbuTarif M, Garimella T, Lee C, Zhang L, Shahidi J, LaCreta F. Exposure-Response Relationships in Patients With HER2-Positive Metastatic Breast Cancer and Other Solid Tumors Treated With Trastuzumab Deruxtecan. Clin Pharmacol Ther. 2021 Oct;110(4):986-996. doi: 10.1002/cpt.2291. Epub 2021 Jun 10.
PMID: 33999422DERIVEDModi S, Saura C, Yamashita T, Park YH, Kim SB, Tamura K, Andre F, Iwata H, Ito Y, Tsurutani J, Sohn J, Denduluri N, Perrin C, Aogi K, Tokunaga E, Im SA, Lee KS, Hurvitz SA, Cortes J, Lee C, Chen S, Zhang L, Shahidi J, Yver A, Krop I; DESTINY-Breast01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):610-621. doi: 10.1056/NEJMoa1914510. Epub 2019 Dec 11.
PMID: 31825192DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Contact for Clinical Trial Information
- Organization
- Daiichi Sankyo
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- In Part 1, about 60 trastuzumab emtansine (T-DM1) resistant/refractory patients initially will be randomized into three treatment groups (low, medium and high doses) for Pharmacokinetics (PK), then about another 60 will be randomized into low and high doses to determine recommended dose (RD). After that, about 100 will receive the recommended dose in an open-label continuation stage (Part 2). About 10 TDM-1 intolerant patients will join the continuation stage as an exploratory only arm.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2017
First Posted
August 14, 2017
Study Start
August 25, 2017
Primary Completion
March 21, 2019
Study Completion
May 6, 2024
Last Updated
June 26, 2025
Results First Posted
February 17, 2020
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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/