Clinical Trials /

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]

NCT03529110

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: DS8201-A-U302
  • SECONDARY ID: 2018-000222-61
  • NCT ID: NCT03529110

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Trastuzumab deruxtecan (DS-8201a)DS-8201aTrastuzumab deruxtecan (DS-8201a)
Ado-trastuzumab emtansine (T-DM1)T-DM1Ado-trastuzumab emtansine (T-DM1)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Trastuzumab deruxtecan (DS-8201a)ExperimentalHER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane randomized to treatment with DS-8201a
  • Trastuzumab deruxtecan (DS-8201a)
Ado-trastuzumab emtansine (T-DM1)Active ComparatorHER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane randomized to treatment with T-DM1
  • Ado-trastuzumab emtansine (T-DM1)

Eligibility Criteria

        Inclusion Criteria:

          -  Is the age of majority in their country

          -  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)

          -  Has an adequate tumor sample available for confirmation of HER2 status by Central
             Laboratory (based on most recent tumor tissue sample)

          -  If of reproductive/childbearing potential, agrees to use a highly effective form of
             contraception or avoid intercourse during the study, and for at least 4.5 months after
             study completion

          -  Has adequate hematopoietic, renal and hepatic functions

        Exclusion Criteria:

          -  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 active central nervous system (CNS) metastases
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (PFS) based on blinded independent central review (BICR)
Time Frame:Within 45 months
Safety Issue:
Description: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

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:At 45 months
Safety Issue:
Description: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
Measure:Objective response rate (ORR) based on BICR and investigator's assessment
Time Frame:Within 45 months
Safety Issue:
Description:Percentage of participants with complete response (CR) and partial response (PR) based on BICR and based on investigator assessment
Measure:Duration of response (DoR) based on BICR and investigator's assessment
Time Frame:Within 45 months
Safety Issue:
Description:Length of time response continued based on BICR and investigator's assessment
Measure:Clinical benefit rate (CBR)
Time Frame:Within 45 months
Safety Issue:
Description:Percentage of participants receiving clinical benefit from the treatment based on BICR and investigator's assessment
Measure:Progression-free survival (PFS) based on investigator's assessment
Time Frame:Within 45 months
Safety Issue:
Description: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

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Daiichi Sankyo, Inc.

Trial Keywords

  • Breast Cancer
  • Metastatic breast cancer
  • DS-8201a

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