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 October 16, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
ACTIVE, NOT RECRUITING (See Contacts and Locations)Verified October 2024 by AstraZeneca, Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo
Sponsor
AstraZenecaInformation Provided by (Responsible Party)
AstraZenecaClinicaltrials.gov Identifier
NCT04494425Other Study ID Numbers: D9670C00001
First Submitted: July 20, 2020
First Posted: July 31, 2020
Last Update Posted: October 17, 2024
Last Verified: October 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 |
|---|---|
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Study Design
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 866 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | None (Open Label) |
| Primary Purpose | Treatment |
| Official Title | 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) |
| Study Start Date | July 24, 2020 |
| Actual Primary Completion Date | March 18, 2024 |
| Anticipated Study Completion Date | June 19, 2026 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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.
- 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
- 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
- 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
- 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
- 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.
- 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
- 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
- Immunogenicity of trastuzumab deruxtecan [Up to follow-up period, approximately 60 months] Percentage of patients who develop ADA for trastuzumab deruxtecan
- 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.
- 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.
- 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 |
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| Exclusion Criteria |
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Contacts and Locations
| Sponsors and Collaborators | AstraZeneca, Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo |
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| Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo | |
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More Information
Additional Information
- AZ Breast Cancer Study Navigators
- Daiichi Sankyo Contact for Clinical Trial Information Phone: 908-992-6400
Additional Relevant MeSH Terms
- Breast Neoplasms
- Neoplasms by Site
- Neoplasms
- Breast Diseases
- Skin Diseases