Clinical Trials /

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

NCT03523585

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: DS-8201a Versus Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Pretreated With Prior Standard of Care [DESTINY-Breast02]
  • 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

Clinical Trial IDs

  • ORG STUDY ID: DS8201-A-U301
  • SECONDARY ID: 2018-000221-31
  • NCT ID: NCT03523585

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Trastuzumab deruxtecanDS-8201aTrastuzumab deruxtecan (DS 8201a)
CapecitabineInvestigator's Choice Comparative TherapyTrastuzumab+capecitabine
LapatinibInvestigator's Choice Comparative TherapyLapatinib+capecitabine
TrastuzumabInvestigator's Choice Comparative TherapyTrastuzumab+capecitabine

Purpose

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.

Detailed Description

      Primary Objective:

        -  To compare the progression-free survival (PFS) benefit of DS 8201a to investigator's
           choice.

      Secondary Objectives:

        -  To further investigate the efficacy of DS 8201a compared to investigator's choice on:

             1. Overall survival (OS);

             2. Objective response rate (ORR);

             3. Duration of response (DoR);

             4. Clinical benefit rate (CBR).

        -  To further determine pharmacokinetics (PK) of DS 8201a.

        -  To further evaluate safety of DS 8201a compared to investigator's choice.

        -  To evaluate Health Economics and Outcomes Research (HEOR) endpoints for DS 8201a
           compared to investigator's choice.
    

Trial Arms

NameTypeDescriptionInterventions
Trastuzumab deruxtecan (DS 8201a)ExperimentalHER2 positive, unresectable and/or metastatic breast cancer subjects previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T DM1) randomized to treatment with DS 8201a
  • Trastuzumab deruxtecan
Trastuzumab+capecitabineActive ComparatorHER2 positive, unresectable and/or metastatic breast cancer subjects previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T DM1) randomized to investigator's choice treatment with Trastuzumab/capecitabine
  • Capecitabine
  • Trastuzumab
Lapatinib+capecitabineActive ComparatorHER2 positive, unresectable and/or metastatic breast cancer subjects previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T DM1) randomized to investigator's choice treatment with Lapatinib/capecitabine
  • Capecitabine
  • Lapatinib

Eligibility Criteria

        Inclusion Criteria:

          -  Adults ≥18 years old.

          -  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)

          -  Documented radiologic progression (during or after most recent treatment or within 6
             mo after completing adjuvant therapy).

          -  Subjects must be HER2 positive as confirmed by central laboratory assessment of most
             recent tumor tissue sample available.

          -  Male and female subjects 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 4.5 months after the last dose of study treatment.

          -  Adequate Adequate hematopoietic, renal and hepatic functions.

        Exclusion Criteria:

          -  Prior treatment with capecitabine.

          -  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.

          -  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:Recruiting
Lead Sponsor:Daiichi Sankyo, Inc.

Trial Keywords

  • Breast Cancer
  • Metastatic breast cancer
  • DS 8201a
  • DESTINY - Breast 02

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