A Study of Tucatinib Given Before Surgery to People with HER2-Positive Cancers That Have Spread to the Brain

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Full Title

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

Purpose

The purpose of this study is to observe the effects of giving the drug tucatinib to people with breast cancer, non-small cell lung cancer (NSCLC), colorectal cancer, or gastroesophageal cancer that makes too much of the HER2 protein (HER2-positive or mutant), has spread to the brain, and needs to be surgically removed from the brain. Tucatinib destroys HER2-positive cancer cells, which may slow or stop the growth of the cancer. Scientists want to learn more about how tucatinib affects cancer that has metastasized to the brain, as well as why some patients benefit from it while others may not. 

Participants in this study who have breast cancer and are already taking tucatinib will continue to take it up to the time of brain surgery. Those who have not taken tucatinib will take it for four days before surgery. Tucatinib is taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have HER2-positive (or mutant) breast cancer, NSCLC, colorectal cancer, or gastroesophageal cancer that has spread to the brain and for which surgery is planned.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Andrew Seidman at 646-888-4559.

Protocol

22-168

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05892068