Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05950945
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-05-22
Brief Title:
Trastuzumab Deruxtecan T-DXd in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 3b Multicenter Global Interventional Open-label Study of Trastuzumab Deruxtecan T-DXd an Anti-HER2-Antibody Drug Conjugate ADC in Subjects Who Have Unresectable andor Metastatic HER2-low or HER2 Immunohistochemistry IHC 0 Breast Cancer DESTINY-Breast15
Status:
RECRUITING
Status Verified Date:
2024-09
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 will evaluate the safety and efficacy of trastuzumab deruxtecan T-DXd in participants with human epidermal growth factor receptor 2 HER2-low or HER2 immunohistochemistry IHC 0 who are both hormone receptor HR-negative and HR-positive unresectable andor metastatic breast cancer
Detailed Description:
The primary endpoint of interest in this study is time to next treatment TTNT a measure that will determine how long T-DXd allows patients to derive clinical benefit from the study drug
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 |
|---|---|---|---|
| 2023-505616-38-00 | OTHER | EU CT | None |