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A Study of Tucatinib Given Before Surgery to People With HER2+ Cancers That Have Spread to the Brain

Metastatic Breast Cancer Clinical Trial

Official title:
Window of Opportunity Analysis of Pre-Operative Tucatinib for Surgically Resected HER2+ Brain Metastases: Understanding Mechanisms of Resistance

Clinical Trial 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.

Clinical Trial 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 and/or local) will be decided according to treating physician discretion and is not a study intervention. Tissue samples of brain metastases along with blood/plasma 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 HER2+/mutant breast cancer who are undergoing clinically indicated brain surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05892068
Study type Interventional
Source Memorial Sloan Kettering Cancer Center
Contact Andrew Seidman, MD
Phone 646-888-4559
Email seidmana@mskcc.org
Status Recruiting
Phase Phase 2
Start date May 9, 2023
Completion date May 9, 2028
View Details
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