Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT06048718
Status:
RECRUITING
Last Update Posted:
2025-04-18
First Post:
2023-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases
Sponsor:
MedSIR
Organization:
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:
2024-11
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-506702-39-00 | OTHER | EU CT | View |