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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
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is the age of majority in their country
  • Has pathologically documented breast cancer that:

    1. is unresectable or metastatic
    2. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
    3. 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
  • 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.

    1. Participants with clinically inactive brain metastases may be included in the study.
    2. 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.

Information from the National Library of Medicine

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


Contacts
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

Locations
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         
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Daiichi Sankyo Co., Ltd.
Investigators
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