Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03523585
Recruitment Status : Recruiting
First Posted : May 14, 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 will compare DS 8201a to standard treatment.

Participants must have HER2 breast cancer that has been treated before.

Their cancer:

  • cannot be removed by an operation
  • has spread to other parts of the body

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Trastuzumab deruxtecan Drug: Capecitabine Drug: Lapatinib Drug: Trastuzumab Phase 3

Detailed Description:
The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1
Actual Study Start Date : August 1, 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
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: Trastuzumab deruxtecan (DS-8201a)
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a
Drug: Trastuzumab deruxtecan
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as intravenous (IV) dose
Other Name: DS-8201a

Active Comparator: Trastuzumab+capecitabine
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine
Drug: Capecitabine
Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
Other Name: Investigator's Choice Comparative Therapy

Drug: Trastuzumab
Investigator's choice Standard of Care when combined with capecitabine
Other Name: Investigator's Choice Comparative Therapy

Active Comparator: Lapatinib+capecitabine
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine
Drug: Capecitabine
Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
Other Name: Investigator's Choice Comparative Therapy

Drug: Lapatinib
Investigator's choice Standard of Care when combined with capecitabine
Other Name: Investigator's Choice Comparative Therapy




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 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 subject before the data cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive.

  2. Objective response rate (ORR) based on BICR and investigator 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 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) based on BICR and investigator assessment [ 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 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.



Information from the National Library of Medicine

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.


Layout table for eligibility information
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 ado-trastuzumab emtansine (T-DM1)
  • 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.
  • Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least:

    1. 4.5 months after the last dose of DS-8201a
    2. 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
    3. 7 months after the last dose of trastuzumab/capecitabine
  • Has adequate hematopoietic, renal and hepatic functions

Exclusion Criteria:

  • Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo
  • Has had prior treatment with capecitabine
  • Has uncontrolled or significant cardiovascular disease
  • Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  • Has active central nervous system (CNS) metastases

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): NCT03523585


Contacts
Layout table for location 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

  Hide Study Locations
Locations
Layout table for location information
United States, California
Pacific Cancer Care Recruiting
Monterey, California, United States, 93940
Contact: Principal Investigator    831-375-4105    lstampleman@pacificcancercare.com   
Cancer Research Collaboration Recruiting
Santa Ana, California, United States, 92705
Contact: Principal Investigator    562-981-6101    wademsmith@breastlink.com   
Innovative Clinical Research Institute Recruiting
Whittier, California, United States, 90603
Contact: Principal Investigator    562-693-4477    omarathe@airesearch.us   
United States, District of Columbia
Washington Cancer Institute Recruiting
Washington, District of Columbia, United States, 20010
Contact: Principal Investigator    202-877-9386    christopher.gallagher@medstar.net   
United States, Georgia
Piedmont Cancer Institute, PC Recruiting
Atlanta, Georgia, United States, 30318
Contact: Principal Investigator    717-724-6780    rsinha@piedmontcancerinstitute.com   
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
Contact: Principal Investigator    502-899-3366    jeffrey.hargis@nortonhealthcare.org   
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Principal Investigator    410-328-3546    ktkaczuk@umm.edu   
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Contact: Principal Investigator    410-783-5858    driseberg@mdmercy.com   
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Principal Investigator    617-632-3339    ian_krop@dfci.harvard.edu   
United States, Missouri
Cornell-Beshore Cancer Institute Recruiting
Joplin, Missouri, United States, 64804
Contact: Principal Investigator    417-347-4000    kjwilliams-wuch@freemanhealth.com   
United States, New York
North Shore Hematology Oncology Associates, PC Recruiting
East Setauket, New York, United States, 11733
Contact: Principal Investigator    631-675-5111    researchpi@nycancer.com   
United States, Ohio
Dayton Physicians, LLC Recruiting
Kettering, Ohio, United States, 45409
Contact: Principal Investigator    937-771-2422    cbane@precisioncancerresearch.com   
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Principal Investigator    412-359-6147    jane.raymond@ahn.org   
United States, Utah
Northern Utah Associates Recruiting
Ogden, Utah, United States, 84405
Contact: Principal Investigator    801-387-7166    nua2@outlook.com   
United States, Washington
MultiCare Health System Institute for Research and Innovation Recruiting
Tacoma, Washington, United States, 98405
Contact: Principal Investigator    253-403-3321    anu.belur@multicare.org   
Japan
NHO Shikoku Cancer Center Recruiting
Ehime, Japan, 791-0280
Contact: See Central Contact         
NHO Kyushu Cancer Center Recruiting
Fukuoka, Japan, 811-1395
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         
Hyōgo College of Medicine Hospital Recruiting
Hyōgo, Japan, 663-8501
Contact: See Central Contact         
St. Marianna University School of Medicine Hospital Recruiting
Kanagawa, Japan, 216-8511
Contact: See Central Contact         
Kanagawa Cancer Center Recruiting
Kanagawa, Japan, 241-8515
Contact: See Central Contact         
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: See Central Contact         
Tohoku University Hospital Recruiting
Miyagi, Japan, 980-8574
Contact: See Central Contact         
Aichi Cancer Center Hospital Recruiting
Nagoya, Japan, 464-8681
Contact: See Central Contact         
Niigata Cancer Center Hospital Recruiting
Niigata, Japan, 951-8566
Contact: See Central Contact         
Okayama University Hospital Recruiting
Okayama, Japan, 700-8558
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         
Saitama Cancer Center Recruiting
Saitama, Japan, 362-0806
Contact: See Central Contact         
Shizuoka Cancer Center Recruiting
Shizuoka, Japan, 411-8777
Contact: See Central Contact         
Toranomon Hospital Recruiting
Tokyo, Japan, 105-8470
Contact: See Central Contact         
The Cancer Institute Hospital of JFCR Recruiting
Tokyo, Japan, 135-8550
Contact: See Central Contact         
Tokyo Medical University Hospital Recruiting
Tokyo, Japan, 160-0023
Contact: See Central Contact         
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Daiichi Sankyo Co., Ltd.
Investigators
Layout table for investigator information
Study Director: Global Team Leader Daiichi Sankyo, Inc.

Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT03523585     History of Changes
Other Study ID Numbers: DS8201-A-U301
2018-000221-31 ( EudraCT Number )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: January 2019
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/

Layout table for additional information
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 02

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Trastuzumab
Lapatinib
Camptothecin
Ado-trastuzumab emtansine
Immunoconjugates
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators