A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

ClinicalTrials.gov processed this data on July 11, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified July 2024 by AstraZeneca, Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

Sponsor

AstraZeneca

Information Provided by (Responsible Party)

AstraZeneca

Clinicaltrials.gov Identifier

NCT04494425
Other Study ID Numbers: D9670C00001
First Submitted: July 20, 2020
First Posted: July 31, 2020
Last Update Posted: July 12, 2024
Last Verified: July 2024
History of Changes

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Study Description

Eligible patients will be those patients who have had disease progression on at least 2 previous lines of endocrine therapies given for the treatment of metastatic disease or disease progression within 6 months of starting first line treatment for metastatic disease with an endocrine therapy combined with a CDK4/6 inhibitor. All patients must have historically confirmed HR positive (either estrogen receptor and/or progesterone receptor positive), HER2-low (defined as IHC2+/ISH- and IHC 1+) or HER2 IHC >0 <1+ expression, as determined by central laboratory testing results, advanced or metastatic breast cancer.

The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy. This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.
Condition or Disease Intervention/Treatment
  • Advanced or Metastatic Breast Cancer
  • Drug: Trastuzumab deruxtecan
  • Drug: Capecitabine
  • Drug: Paclitaxel
  • Drug: Nab-Paclitaxel

Study Design

Study TypeInterventional
Actual Enrollment866 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
Study Start DateJuly 24, 2020
Actual Primary Completion DateMarch 18, 2024
Anticipated Study Completion DateJune 19, 2026

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Trastuzumab deruxtecan
    • Trastuzumab deruxtecan (T-DXd; DS-8201a) arm
  • Drug: Trastuzumab deruxtecan
    • Trastuzumab deruxtecan by intravenous infusion
  • Standard of Care
    • Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm
  • Drug: Capecitabine
    • Drug: Paclitaxel
      • Drug: Nab-Paclitaxel

        Outcome Measures

        Primary Outcome Measures

        1. Progression Free Survival (PFS) - in HR+, HER2-low populaton [Until progression or death, assessed up to approximately 60 months]
          Defined as time from date of randomization until the date of objective radiological disease progression by blinded independent central review (BICR) assessment according to RECIST 1.1 or death.

        Secondary Outcome Measures

        1. Overall Survival (OS) - in HR+, HER2-low population [Until death, assessed up to approximately 60 months]
          Defined as the time from randomization to death due to any cause
        2. Progression Free Survival (PFS) - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+) [Until progression or death, assessed up to approximately 60 months]
          PFS by BICR according to RECIST 1.1 in ITT population
        3. Overall Survival - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+) [Until death, assessed up to approximately 60 months]
          OS in the ITT population
        4. Objective Response Rate (ORR) in HR+, HER-2 low populaton [Until progression, assessed up to approximately 60 months]
          ORR defined as the percentage of patients with at least one visit response of complete or partial response (CR or PR) by BICR and Investigator assessment according to RECIST 1.1.
        5. Duration of response (DoR) - in HR+, HER-2 low populaton [Until progression, assessed up to approximately 60 months]
          DoR defined as the time from the date of first documented response (CR/PR) until the first progression or death in the absence of disease progression by BICR and Investigator assessment according to RECIST 1.1
        6. Progression Free Survival by Investigator assessment - in the HR+, HER2-low population [Until progression or death, assessed up to approximately 60 months]
          PFS using investigator assessments according to RECIST 1.1 in the HER2-low population
        7. Objective Response Rate (ORR) in the ITT population [Until progression, assessed up to approximately 60 months]
          ORR by BICR and by Investigator assessment according to RECIST 1.1 in the ITT population
        8. Duration of response (DoR) - in the ITT population [Until progression, assessed up to approximately 60 months]
          DoR by BICR and by Investigator assessment according to RECIST 1.1 in the ITT population
        9. PFS2 by Investigator assessment, time to first subsequent therapy (TFST) and time to second subsequent treatment or death (TSST) - in HR+, HER2-low and the ITT population [Assessed up to approximately 60 months]
          PFS2 defined as time from randomisation to second progression or death. TFST defined as a time elapsed from randomization to first subsequent therapy or death. TSST defined as a time elapsed from randomization to second subsequent therapy or death.
        10. Safety and tolerability of drugs; number of adverse events (AEs) [Up to follow-up period, approximately 60 months]
          Number of AEs according to NCI-CTCAE Version 5.0 per each treatment arm
        11. Serum concentration of trastuzumab deruxtecan [Up to Cycle 8, approximately Week 24; each cycle is 21 days]
          Determination of trastuzumab deruxtecan concentration in serum at different time points after trastuzumab deruxtecan administration
        12. Immunogenicity of trastuzumab deruxtecan [Up to follow-up period, approximately 60 months]
          Percentage of patients who develop ADA for trastuzumab deruxtecan
        13. Health-related quality of life - EORTC-QLQ-C30 [Assessed up to approximately 60 months]
          Change from baseline in the physical functioning subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/ QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.
        14. Time to deterioration in EORTC-QLQ-C30 scores [Assessed up to approximately 60 months]
          Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.
        15. Health-related quality of life - EORTC QLQ-BR45 [Assessed up to approximately 60 months]
          Change from baseline in the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR45) score. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.

        Eligibility Criteria

        Ages Eligible for Study 18 Years to 105 Years (Adult, Older Adult)
        Sexes Eligible for Study All
        Accepts Healthy Volunteers No
        Inclusion Criteria
        • a:
        • Patients must be ≥18 years of age
        • Pathologically documented breast cancer that:
        • is advanced or metastatic
        • has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested)
        • has HER2-low or HER2 IHC >0 <1+ expression as determined by the central laboratory result established on a tissue sample taken in the metastatic setting
        • was never previously HER2-positive
        • is documented HR+ disease in the metastatic setting.
        • No prior chemotherapy for advanced or metastatic breast cancer.
        • Has adequate tumor samples for assessment of HER2 status
        • Must have either:
        • disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor or
        • disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting. Of note with regards to the ≥2 lines of previous ET requirement: disease recurrence while on the first 24 months of starting adjuvant ET, will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting.
        • Has protocol-defined adequate organ and bone marrow function
        • Ke
        Exclusion Criteria
        • Ineligible for all options in the investigator's choice chemotherapy arm
        • Lung-specific intercurrent clinically significant illnesses
        • Uncontrolled or significant cardiovascular disease or infection
        • Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening.
        • Patients with spinal cord compression or clinically active central nervous system metastases
        • Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment
        • Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study during the follow up period of a prior interventional study (prescreening for this study while a patient is on treatment in another clinical study is acceptable)

        Contacts and Locations

        Sponsors and Collaborators AstraZeneca, Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo
        Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo
        Locations
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        More Information

        Additional Information

        Additional Relevant MeSH Terms

        • Breast Neoplasms
        • Neoplasms by Site
        • Neoplasms
        • Breast Diseases
        • Skin Diseases