Clinical Trial: NCT03523585
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Daiichi Sankyo |
| Information Provided By: | Daiichi Sankyo |
| Last Update Posted: | 2026-02-27 |
Study Overview
Brief Summary
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
Official Title
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Trastuzumab deruxtecan
- Drug: Capecitabine
- Drug: Lapatinib
- Drug: Trastuzumab
Other Study ID Numbers
- DS8201-A-U301
- 2018-000221-31
- 184017
- DESTINY-Breast02
- 2018
Start Date (Actual)
2018-08-01
Primary Completion Date (Actual)
2022-06-30
Study Completion Date (Actual)
2025-12-23
Enrollment (Actual)
608
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Daiichi Sankyo |
| Information Provided By: | Daiichi Sankyo |
| Last Update Posted: | 2026-02-27 |
Study Overview
Brief Summary
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
Official Title
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Trastuzumab deruxtecan
- Drug: Capecitabine
- Drug: Lapatinib
- Drug: Trastuzumab
Other Study ID Numbers
- DS8201-A-U301
- 2018-000221-31
- 184017
- DESTINY-Breast02
- 2018
Start Date (Actual)
2018-08-01
Primary Completion Date (Actual)
2022-06-30
Study Completion Date (Actual)
2025-12-23
Enrollment (Actual)
608
Study Type
Interventional
Phase
Phase 3