Study on Tucatinib Before Surgery for People with HER2+ Cancers That Have Spread to the Brain

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05892068

Provider View

This clinical trial is exploring how the drug tucatinib is absorbed and processed in the brain for patients with HER2+ cancers that have spread to the brain. The study also aims to understand how cancer cells develop resistance to treatment.

Patient Parameters

Program Overview

The purpose of this study is to see how tucatinib, a medication, is absorbed, distributed, and eliminated in the brains of people with HER2+ cancers, such as breast cancer, non-small cell lung cancer (NSCLC), colorectal cancer (CRC), or gastroesophageal cancer (GEC), that have spread to the brain. Researchers will also study genetic differences in cancer cells to understand how they become resistant to treatment. This involves comparing cancer cells from patients who have been treated with tucatinib before and those who are receiving it for the first time.

Description

All participants in this study will take tucatinib at a standard dose of 300 mg by mouth twice daily for five days before surgery. After surgery, the type of treatment you receive will be decided by your doctor and is not part of the study. During surgery, tissue samples from brain tumors, along with blood and spinal fluid samples, will be collected to study how well tucatinib penetrates brain tumors and how the body responds to the drug. Patients may continue taking tucatinib after surgery if their doctor recommends it, but this is not part of the study for some groups. For others, continuing tucatinib post-surgery is part of the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to make decisions.
  • Have HER2+ cancer (breast, lung, esophagogastric, or colorectal) that has spread to the brain and requires brain surgery.
  • May have other untreated brain tumors and previous radiation treatment is allowed.
  • Can have leptomeningeal disease if brain surgery is needed.
  • Expected to live more than 12 weeks.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Previous treatments:
    • For Cohort A: Cancer has progressed in the brain despite tucatinib treatment for HER2+ breast cancer.
    • Cancer has progressed in the brain without prior tucatinib treatment for HER2+ breast cancer.
    • Cancer has progressed in the brain for HER2+ lung, esophagogastric, colorectal cancer, or HER2 mutant breast cancer.
  • Previous use of lapatinib and neratinib is allowed if more than 6 months ago.
  • No limit on previous systemic therapies.
  • Adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must be able to swallow pills.

Exclusion Criteria

  • Allergic to tucatinib or its ingredients.
  • Have significant medical conditions as determined by the study doctor.
  • Unable to follow the study protocol or attend follow-up visits.
  • Have used certain medications that affect tucatinib within a specific time frame.
  • Taking medications that could interact dangerously with tucatinib.
  • Currently pregnant.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.