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Breast CancerPhase 2NCT03248492

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

A Phase 2 study testing DS-8201a in people with Breast Cancer, run by Daiichi Sankyo at 99 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. 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?
DS-8201a
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
253 participants
Where
99 sitesin 9 countries
Study dates
25 Aug 2017to 6 May 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

99 sites in 9 countries.

99 sites in 9 countries

United States36 sites

  • Alaska Urological Institute dba Alaska Clinical Research Center

    Anchorage, Alaska, 99508

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318

  • Accurate Clinical Research

    Baytown, Texas, 77521

  • Sylvester Comprehensive Cancer Center - Deerfield Beach

    Boca Raton, Florida, 33426

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Aultman Hospital Cancer Center

    Canton, Ohio, 44710

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists

    East Setauket, New York, 11733

  • Providence Regional Medical Center - Everett

    Everett, Washington, 98201

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • St Francis Hospital

    Greenville, South Carolina, 29601

  • Specialist Global Research

    Hialeah, Florida, 33012

  • Straub Medical Center

    Honolulu, Hawaii, 96813

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • Texas Oncology - Memorial City

    Houston, Texas, 77024

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • The Regents of the University of California

    Los Angeles, California, 90095

  • Norton Healthcare

    Louisville, Kentucky, 40202

  • University of Louisville Research Foundation

    Louisville, Kentucky, 40202

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70120

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Sharp Clinical Oncology Research

    San Diego, California, 92123

  • University of California San Francisco

    San Francisco, California, 94115

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Arizona Oncology Associates

    Tucson, Arizona, 85704

  • Texas Oncology, P.A. - Longview

    Tyler, Texas, 75702

  • The University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708

  • Innovative Clinical Research Institute, LLC

    Whittier, California, 90603

Other trials in United States

France15 sites

  • Institut Sainte Catherine

    Avignon, 84918

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • Centre Georges François Leclerc

    Dijon, 21079

  • CHU Bordeaux - Hôpital Saint André

    Gironde, 33075

  • CH de la Rochelle - Hopital St Louis

    La Rochelle, 17019

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, 72015

  • Hôpital Nord - CHU Marseille

    Marseille, 13915

  • Institut Régional du Cancer de Montpellier

    Montpellier, 34298

  • Centre Catherine de Sienne

    Nantes, 44202

  • Hôpital Saint-Louis - Paris

    Paris, 75475

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CRLCC Eugene Marquis

    Rennes, 35042

  • Hôpital d'Instruction des Armees Begin

    Saint-Mandé, 94160

  • Centre Paul Strauss

    Strasbourg, 67000

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Japan11 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • NHO Kyushu Cancer Center

    Fukuoka, 811-1395

  • Hakuaikai Sagara Hospital

    Kagoshima, 892-0833

  • Kanagawa Cancer Center

    Kanagawa, 241-0815

  • NHO Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Toranomon Hospital

    Minatoku, Tokyo-To, 105-8470

  • Kindai University Hospital

    Osaka, 589-8511

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • St. Luke's International Hospital

    Tokyo, 104-8560

  • Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

Other trials in Japan

Spain11 sites

  • Hospital Infanta Cristina

    Badajoz, 6080

  • Hospital Universitari Quiron Dexeus

    Barcelona, 08028

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • ICO l´Hospitalet - Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital Quiron Barcelona

    Barcelona, 8023

  • MD Anderson Cancer Centre

    Madrid, 28033

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Instituto Valenciano de Oncologia IVO

    Valencia, 46009

Other trials in Spain

South Korea8 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • National Cancer Center

    Goyang-si, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Italy6 sites

  • Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

    Monza, 20900

  • Ospedale degli Infermi

    Rimini, 47923

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Torrette, 60020

Other trials in Italy

United Kingdom6 sites

  • Western General Hospital

    Edinburgh, Lothian Region, EH4 2XU

  • Royal Surrey County Hospital

    Guildford, Surrey, GU2 7XX

  • Queen Mary University of London

    London, Greater London, EC1M 6BQ

  • University College London Hospitals

    London, Greater London, NW1 2PG

  • Nottingham University Hospitals City Campus

    Nottingham, Nottinghamshire, NG5 1PB

  • Derriford Hospital

    Plymouth, Devon, PL6 8BQ

Other trials in United Kingdom

Belgium5 sites

  • Imeldaziekenhuis

    Bonheiden, 2820

  • Grand Hôpital de Charleroi

    Charleroi, 6000

  • UZ Leuven

    Leuven, 3000

  • CHU Sart Tilman

    Liège, 4000

  • AZ Sint-Maarten

    Mechelen, 2800

Other trials in Belgium

Canada1 site

  • University of Calgary

    Calgary, Alberta, T2N 4N2

Other trials in Canada

About this study

Official title: 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.

Conditions
Breast Cancer
Being tested
DS-8201a
Keywords
HER-2 positive breast cancer, Metastatic or Unresectable, Resistant or refractory to T-DM1, DESTINY - Breast 01, Trastuzumab deruxtecan, T-DXd
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

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

  • DS-8201aDrug

    Also called Experimental product

    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.

Study groups in NCT03248492
Study groupRoleWhat they receive
DS-8201a Low DoseExperimentalT-DM1 resistant/refractory (R/R) patients in the low dose treatment group
Receives: Drug: DS-8201a
DS-8201a Medium DoseExperimentalT-DM1 resistant/refractory (R/R) patients in the medium dose treatment group
Receives: Drug: DS-8201a
DS-8201a High DoseExperimentalT-DM1 resistant/refractory (R/R) patients in the high dose treatment group
Receives: Drug: DS-8201a
Exploratory ArmOtherIn Part 2b- Continuation Stage, about 10 T-DM1 Intolerant patients will receive the DS-8201a recommended dose (RD) as an exploratory arm
Receives: Drug: DS-8201a

What is being measured

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

  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.

    Measured: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)

Secondary outcomes (7)

  1. Objective Response Rate as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)

    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.

    Measured: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)

  2. Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)

    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.

    Measured: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)

  3. 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)

    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.

    Measured: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)

  4. 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)

    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.

    Measured: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)

  5. 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)

    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.

    Measured: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)

  6. 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)

    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.

    Measured: Baseline up to Week 6, 12, 18, 24, 30, 36 post dose

  7. Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)

    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.

    Measured: Day 0 to Day 47 post last dose

Timeline

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

  1. First posted14 Aug 2017
  2. Study start25 Aug 2017
  3. Primary completion21 Mar 2019
  4. Study completion6 May 2024

Why it stopped: The last participant was transitioned to alternative study.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
HER2-positive patients will be classified into two groups: T-DM1 resistant/refractory (experimental) and T-DM1 intolerant (exploratory only).
Masking
None (open label)
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03248492
Sponsor's protocol ID
DS8201-A-U201
Other IDs
2016-004986-18, JapicCTI-173693(en), DESTINY-Breast01, 2016
Status last verified
Jun 2025
First submitted
10 Aug 2017
Last updated
26 Jun 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • 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.

    PubMed 36342619

  • Rugo 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.

    PubMed 35964548

  • Bardia 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.

    PubMed 35642907

  • Modi 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.

    PubMed 34263665

  • Yin 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.

    PubMed 33999422

  • Modi 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.

    PubMed 31825192

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DS-8201a in people with Breast Cancer, run by Daiichi Sankyo at 99 sites in 9 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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, France, Japan, Spain, South Korea and 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). 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 NCT03248492, which also lists 6 linked publications.

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 26 Jun 2025.

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