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

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ClinicalTrials.gov Identifier: NCT03523585
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
Daiichi Sankyo Co., Ltd.
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE April 13, 2018
First Posted Date  ICMJE May 14, 2018
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
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 RECIST version 1.1 or death due to any cause
Change History Complete list of historical versions of study NCT03523585 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • 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.
  • 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
  • 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) 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • 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
  • Objective response rate (ORR) based on BICR and investigator assessment [ Time Frame: Within 45 months ]
    Percentage of participants with complete response (CR) and 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 from the treatment based on BICR and investigator's assessment
  • Progression-free survival (PFS) based on investigator's assessment [ Time Frame: Within 45 months ]
    PFS based on investigator's assessment is time from the date of randomization to the earliest date of the first objective documentation of radiographic disease progression via investigator-assessed disease progression according to RECIST version 1.1 or death due to any cause
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
Official Title  ICMJE 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
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
  • 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
  • Drug: Trastuzumab
    Investigator's choice Standard of Care when combined with capecitabine
    Other Name: Investigator's Choice Comparative Therapy
Study Arms  ICMJE
  • 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
    Intervention: Drug: Trastuzumab deruxtecan
  • 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
    Interventions:
    • Drug: Capecitabine
    • Drug: Trastuzumab
  • 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
    Interventions:
    • Drug: Capecitabine
    • Drug: Lapatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2018)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Czechia,   France,   Greece,   Israel,   Italy,   Japan,   Korea, Republic of,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03523585
Other Study ID Numbers  ICMJE DS8201-A-U301
2018-000221-31 ( EudraCT Number )
184017 ( Registry Identifier: JAPIC CTI )
DESTINY-B02 ( Other Identifier: Daiichi Sankyo and AstraZeneca )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE
  • Daiichi Sankyo Co., Ltd.
  • AstraZeneca
Investigators  ICMJE
Study Director: Global Team Leader Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP