Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05892068
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2023-05-18
Brief Title:
A Study of Tucatinib Given Before Surgery to People With HER2 Cancers That Have Spread to the Brain
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Window of Opportunity Analysis of Pre-Operative Tucatinib for Surgically Resected HER2 Brain Metastases Understanding Mechanisms of Resistance
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this study to see how the brain absorbs distributes and gets rid of tucatinib in people who have HER2 cancers breast cancer NSCLC CRC or GEC that have spread to the brain and to learn more about how cancer cells develop resistance to treatment The researchers will do research tests to look for genetic differences between HER2 breast cancer that has spread to the brain and progressed during treatment with tucatinib and cancers that are being treated with tucatinib for the first time
Detailed Description:
All patients will receive tucatinib per-protocol at standard dose of 300 mg orally twice daily on days - 4 -3 -2 -1 and day 0 in AM The post-surgery treatment systemic andor local will be decided according to treating physician discretion and is not a study intervention Tissue samples of brain metastases along with bloodplasma and CSF samples will be analyzed to evaluate brain tumor penetration of tucatinib as well as biologic response to tucatinib in patients with brain metastases from HER2mutant breast cancer who are undergoing clinically indicated brain surgery Patients may continue tucatinib post-operatively at the discretion of the treating oncologist with monitoring as per clinical routine this is not a study intervention for Cohort A and Cohort B Patients on Cohort C may receive tucatinib post-operatively through the study according to physician descretion
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?:
False
Is an FDA AA801 Violation?:
None