Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04512261
Status:
WITHDRAWN
Last Update Posted:
2022-07-01
First Post:
2020-07-28
Brief Title:
TOPAZ Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases
Sponsor:
Reva Basho
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
TOPAZ Single Arm Open Label Phase 1b2 Study of Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases
Status:
WITHDRAWN
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study withdrawn due to change in treatment landscape for HER2 metastatic breast cancer
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOPAZ
Brief Summary:
This is a single arm open label trial to assess the safety and efficacy of tucatinib in combination with pembrolizumab and trastuzumab for the treatment of HER2 breast cancer brain metastases BCBM A total of 33 patients with untreated or previously treated and progressing HER2 BCBM not requiring urgent central nervous system CNS-directed therapy will be enrolled The study will determine the recommended dose of tucatinib in this combination and assess the efficacy of this combination in controlling CNS disease in patients with HER2 BCBM
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