Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06048718
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2023-09-06
Brief Title:
T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases
Sponsor:
MedSIR
Organization:
MedSIR
Study Overview
Official Title:
Phase II Study of Trastuzumab-Deruxtecan T-DXd DS-8201a in HER2-Low Breast Cancer Patients Presenting With Newly Diagnosed or Progressing Brain Metastases
Status:
RECRUITING
Status Verified Date:
2023-09
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:
TUXEDO-4
Brief Summary:
TUXEDO-4 is an international multicentric single arm phase II study aiming to gather additional solid evidence of Trastuzumab-Deruxtecan T-DXd activity in patients with Human Epidermal Growth Factor Receptor 2 HER2-low breast cancer with active brain metastases
This study will analyze the efficacy of T-DXd as determined by overall response rate ORR at any timepoint as judged by best CNS response according to RANO-BM criteria
This study will analyze the efficacy of T-DXd as determined by overall response rate ORR at any timepoint as judged by best CNS response according to RANO-BM criteria
Detailed Description:
This is an international multicentric single arm phase II study to evaluate the safety and efficacy of T-DXd in HER2-low breast cancer with newly diagnosed or progressing brain metastases with or without untreated type II leptomeningeal disease LMD
Upon meeting all selection criteria a total of 27 patients will be enrolled as follows 13 patients will be accrued in stage 1 to receive T-DXd and additional 14 patients will be accrued in stage 2 according to the number of responses seen in stage 1
The main objective is to analyze the efficacy of T-DXd as determined by ORR at any timepoint as judged by best CNS response according to RANO-BM criteria
End of study is estimated to occur approximately 11 months after the last patient included in the study starts treatment unless premature termination of the study
Upon meeting all selection criteria a total of 27 patients will be enrolled as follows 13 patients will be accrued in stage 1 to receive T-DXd and additional 14 patients will be accrued in stage 2 according to the number of responses seen in stage 1
The main objective is to analyze the efficacy of T-DXd as determined by ORR at any timepoint as judged by best CNS response according to RANO-BM criteria
End of study is estimated to occur approximately 11 months after the last patient included in the study starts treatment unless premature termination of the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506702-39-00 | OTHER | EU CT | None |