Spots Global Cancer Trial Database for A Study of Tucatinib Given Before Surgery to People With HER2+ Cancers That Have Spread to the Brain
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study of Tucatinib Given Before Surgery to People With HER2+ Cancers That Have Spread to the Brain
Official Title: Window of Opportunity Analysis of Pre-Operative Tucatinib for Surgically Resected HER2+ Brain Metastases: Understanding Mechanisms of Resistance
Study ID: NCT05892068
Conditions
Interventions
Study Description
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 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Memorial Sloan Kettering Cancer Center (Limited Protocol Activities), Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities), Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States
Contact Details
Name: Andrew Seidman, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
