Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03529110
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2018-04-13
Brief Title:
DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 HER2-Positive Unresectable andor Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane DESTINY-Breast03
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
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 andor Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor metastatic breast cancer subjects previously treated with trastuzumab and taxane
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20190378 | REGISTRY | CDE | None |
| 2018-000222-61 | EUDRACT_NUMBER | None | None |
| 183976 | REGISTRY | None | None |
| DESTINY-B03 | OTHER | None | None |