Clinical Trial: NCT03529110
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]
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Daiichi Sankyo |
| Information Provided By: | Daiichi Sankyo |
| Last Update Posted: | 2026-10-07 |
Study Overview
Brief Summary
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.
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
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Trastuzumab deruxtecan (T-DXd)
- Drug: Ado-trastuzumab emtansine (T-DM1)
Other Study ID Numbers
- DS8201-A-U302
- 2018-000222-61
- jRCT2080223919
- DESTINY-B03
- CTR20190378
- 2024-511204-16-00
- 2018
Start Date (Actual)
2018-08-09
Primary Completion Date (Actual)
2021-05-21
Study Completion Date (Actual)
2026-08-31
Enrollment (Actual)
524
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Daiichi Sankyo |
| Information Provided By: | Daiichi Sankyo |
| Last Update Posted: | 2026-10-07 |
Study Overview
Brief Summary
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.
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
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Trastuzumab deruxtecan (T-DXd)
- Drug: Ado-trastuzumab emtansine (T-DM1)
Other Study ID Numbers
- DS8201-A-U302
- 2018-000222-61
- jRCT2080223919
- DESTINY-B03
- CTR20190378
- 2024-511204-16-00
- 2018
Start Date (Actual)
2018-08-09
Primary Completion Date (Actual)
2021-05-21
Study Completion Date (Actual)
2026-08-31
Enrollment (Actual)
524
Study Type
Interventional
Phase
Phase 3