Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752059
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2021-01-26
Brief Title:
Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Phase II Study of Trastuzumab-Deruxtecan T-DX DS-8201a in HER2-positive Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Status:
COMPLETED
Status Verified Date:
2023-05
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:
TUXEDO-1
Brief Summary:
Trastuzumab-Deruxtecan T-DXd DS-8201a in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases
Detailed Description:
T-DXd will be administered at a dose of 54 mgkg body weight once every three weeks in patients with newly diagnosed or progressive HER2 positive breast cancer brain metastases Response rate by RANO-BM is defined the primary study endpoint
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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