DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
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ClinicalTrials.gov Identifier: NCT03529110 |
Recruitment Status :
Recruiting
First Posted : May 18, 2018
Last Update Posted : February 12, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: Trastuzumab deruxtecan (DS-8201a) Drug: Ado-trastuzumab emtansine (T-DM1) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane |
Actual Study Start Date : | July 20, 2018 |
Estimated Primary Completion Date : | February 2022 |
Estimated Study Completion Date : | February 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Trastuzumab deruxtecan (DS-8201a)
HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane randomized to treatment with DS-8201a
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Drug: Trastuzumab deruxtecan (DS-8201a)
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously
Other Name: DS-8201a |
Active Comparator: Ado-trastuzumab emtansine (T-DM1)
HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane randomized to treatment with T-DM1
|
Drug: Ado-trastuzumab emtansine (T-DM1)
The treatment will be in accordance with the approved label
Other Name: T-DM1 |
- Progression-free survival (PFS) based on blinded independent central review (BICR) [ Time Frame: Within 45 months ]Time from the date of randomization to the earliest date of the first objective documentation of radiographic disease progression via BICR according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1 or death due to any cause
- Overall survival (OS) [ Time Frame: At 45 months ]Time from the date of randomization to the date of death for any cause. If there is no death reported for a participant before the data cutoff for OS analysis, OS will be censored at the last contact date at which the participant is known to be alive.
- Objective response rate (ORR) based on BICR and investigator's assessment [ Time Frame: Within 45 months ]Percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR), based on BICR and based on investigator assessment
- Duration of response (DoR) based on BICR and investigator's assessment [ Time Frame: Within 45 months ]Length of time response continued, based on BICR and investigator's assessment
- Clinical benefit rate (CBR) [ Time Frame: Within 45 months ]Percentage of participants receiving clinical benefit (CR, PR or more than 6 months stable disease) from the treatment, based on BICR and investigator's assessment
- Progression-free survival (PFS) based on investigator's assessment [ Time Frame: Within 45 months ]Time from the date of randomization to the first objective documentation of radiographic disease progression via investigator assessment, according to mRECIST version 1.1 or death due to any cause

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Is the age of majority in their country
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Has pathologically documented breast cancer that:
- is unresectable or metastatic
- has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
- was previously treated with trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane
- Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
- Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
- If of reproductive/childbearing potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for at least 4.5 months after the last dose of DS-8201a or 7 months after the last dose of T-DM1
- Has adequate renal and hepatic function
Exclusion Criteria:
- Has previously been treated with an anti-HER2 antibody drug conjugate (ADC)
- Has uncontrolled or significant cardiovascular disease
- Has a history of (noninfectious) 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
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Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- Participants with clinically inactive brain metastases may be included in the study.
- Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529110
Contact: (For Sites in Asia Only) Daiichi Sankyo Contact for Clinical Trial Information | +81-3-6225-1111(M-F 9-5 JST) | dsclinicaltrial@daiichisankyo.co.jp |
United States, California | |
Pacific Cancer Care | Recruiting |
Monterey, California, United States, 93940 | |
Contact: Site Coordinator 831-375-4105 DTenney@pacificcancercare.com | |
Cancer Research Collaboration | Recruiting |
Santa Ana, California, United States, 92705 | |
Contact: Principal Investigator 562-981-6101 WadeSmith@veritymed.org | |
Innovative Clinical Research Institute | Recruiting |
Whittier, California, United States, 90603 | |
Contact: Site Coordinator 562-693-4477 rjimenez@icrinstitute.com | |
United States, District of Columbia | |
Washington Cancer Institute | Recruiting |
Washington, District of Columbia, United States, 20010 | |
Contact: Site Coordinator 202-877-9386 mhri.oncology@medstar.net | |
United States, Georgia | |
Piedmont Cancer Institute, PC | Recruiting |
Atlanta, Georgia, United States, 30318 | |
Contact: Site Coordinator 678-298-3241 ajohnston@piedmontcancerinstitute.com | |
United States, Maryland | |
Mercy Medical Center | Recruiting |
Baltimore, Maryland, United States, 21202 | |
Contact: Site Coordinator 410-951-7908 agerbasi@mdmercy.com | |
United States, New York | |
North Shore Hematology Oncology Associates, PC | Recruiting |
East Setauket, New York, United States, 11733 | |
Contact: Site Coordinator 631-675-5143 dmarx@nycancer.com | |
United States, Ohio | |
Dayton Physicians, LLC | Recruiting |
Kettering, Ohio, United States, 45409 | |
Contact: Site Coordinator 937-771-2287 snortman@daytonphysicians.com | |
United States, Tennessee | |
Tennessee Oncology- St Thomas Location | Recruiting |
Nashville, Tennessee, United States, 37205 | |
Contact: Site Coordinator 615-524-4016 cann.studyactivation@sarahcannon.com | |
United States, Utah | |
Northern Utah Associates | Recruiting |
Ogden, Utah, United States, 84405 | |
Contact: Site Coordinator 801-387-7166 nua@nmail.email | |
United States, Washington | |
MultiCare Health System Institute for Research and Innovation | Recruiting |
Auburn, Washington, United States, 98001 | |
Contact: Site Coordinator 253-209-8972 srebar@multicare.org | |
Japan | |
NHO Shikoku Cancer Center | Recruiting |
Matsuyama-shi, Ehime-Ken, Japan, 791-0280 | |
Contact: See Central Contact | |
NHO Kyushu Cancer Center | Recruiting |
Fukuoka-shi, Fukuoka-Ken, Japan, 811-1395 | |
Contact: See Central Contact | |
Hyogo College of Medicine Hospital | Recruiting |
Nishinomiya-shi, Hyogo-Ken, Japan, 663-8501 | |
Contact: See Central Contact | |
St. Marianna University School of Medicine Hospital | Recruiting |
Kawasaki-shi, Kanagawa-Ken, Japan, 216-8511 | |
Contact: See Central Contact | |
Tohoku University Hospital | Recruiting |
Sendai-shi, Miyagi-Ken, Japan, 980-8574 | |
Contact: See Central Contact | |
Okayama University Hospital | Recruiting |
Okayama-shi, Okayama-Ken, Japan, 700-8558 | |
Contact: See Central Contact | |
Shizuoka Cancer Center | Recruiting |
Nagaizumi, Shizuoka-Ken, Japan, 411-8777 | |
Contact: See Central Contact | |
Showa University Hospital | Recruiting |
Shinagawa-Ku, Tokyo-To, Japan, 142-8666 | |
Contact: See Central Contact | |
Tokyo Medical University Hospital | Recruiting |
Shinjuku-ku, Tokyo-To, Japan, 160-0023 | |
Contact: See Central Contact | |
Aichi Cancer Center Hospital | Recruiting |
Aichi, Japan, 464-8681 | |
Contact: See Central Contact | |
Hiroshima City Hiroshima Citizens Hospital | Recruiting |
Hiroshima, Japan, 730-8518 | |
Contact: See Central Contact | |
NHO Hokkaido Cancer Center | Recruiting |
Hokkaido, Japan, 003-0804 | |
Contact: See Central Contact | |
Kanagawa Cancer Center | Recruiting |
Kanagawa, Japan, 241-8515 | |
Contact: See Central Contact | |
Niigata Cancer Center | Recruiting |
Niigata, Japan, 951-8566 | |
Contact: See Central Contact | |
NHO Osaka National Hospital | Recruiting |
Osaka, Japan, 540-0006 | |
Contact: See Central Contact | |
Osaka International Cancer Institute | Recruiting |
Osaka, Japan, 541-8567 | |
Contact: See Central Contact | |
Satiama Cancer Center | Recruiting |
Saitama, Japan, 362-0806 | |
Contact: See Central Contact | |
National Cancer Center Hospital | Recruiting |
Tokyo, Japan, 104-0045 | |
Contact: See Central Contact | |
The Cancer Institute Hospital of JFCR | Recruiting |
Tokyo, Japan, 135-8550 | |
Contact: See Central Contact |
Study Director: | Global Team Leader | Daiichi Sankyo, Inc. |
Responsible Party: | Daiichi Sankyo, Inc. |
ClinicalTrials.gov Identifier: | NCT03529110 History of Changes |
Other Study ID Numbers: |
DS8201-A-U302 2018-000222-61 ( EudraCT Number ) |
First Posted: | May 18, 2018 Key Record Dates |
Last Update Posted: | February 12, 2019 |
Last Verified: | December 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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/ |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (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. |
URL: | https://vivli.org/ourmember/daiichi-sankyo/ |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Daiichi Sankyo, Inc.:
Breast Cancer Metastatic breast cancer DS-8201a DESTINY - Breast 03 |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Taxane Ado-trastuzumab emtansine Trastuzumab Maytansine Camptothecin Immunoconjugates |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Immunologic Factors Physiological Effects of Drugs |