Study on Preventing Brain Metastases in Advanced HER2+ Breast Cancer Patients Using Tucatinib

Sponsor: Carey Anders, M.D.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05323955

Provider View

This clinical trial is exploring whether adding the drug tucatinib to standard treatments can help prevent brain metastases in patients with advanced HER2+ breast cancer who have experienced brain metastases but have stable disease elsewhere in the body.

Patient Parameters

Program Overview

The study involves patients with advanced HER2+ breast cancer who have had brain metastases while on treatments like trastuzumab/pertuzumab or T-DM1. Participants will receive local treatments like stereotactic radiosurgery or surgery for brain metastases, followed by continued standard treatment with the addition of tucatinib. The study aims to see if this combination can help control the disease without causing intolerable side effects. If the cancer outside the brain progresses but the brain metastases remain stable, patients may continue tucatinib in their next line of therapy.

Description

This study is for patients with advanced HER2+ breast cancer who have experienced brain metastases while on certain treatments. Participants will continue their current treatment, such as trastuzumab/pertuzumab or T-DM1, and add tucatinib to their regimen. The goal is to see if this combination can help prevent further brain metastases. Patients will receive local treatment for brain metastases, like stereotactic radiosurgery or surgery, before starting the study treatment. The study will continue until the disease progresses in the brain or side effects become too severe. If the cancer outside the brain progresses but the brain metastases remain stable, patients may continue tucatinib in their next line of therapy. Participants will be monitored closely throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and authorization for health information release.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0-2.
  • Have advanced or metastatic HER2+ breast cancer with brain metastases.
  • Currently receiving specific treatments like trastuzumab/pertuzumab or T-DM1.
  • Stable disease outside the brain.
  • Adequate liver, kidney, and blood function.
  • Completed local treatment for brain metastases, such as surgery or radiosurgery.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Men and women must agree to use contraception during the study.

Exclusion Criteria

  • Previous treatment with certain drugs like tucatinib or other HER2 inhibitors.
  • Significant heart or lung disease.
  • Active infections like tuberculosis, hepatitis B or C, or HIV.
  • Unable to undergo an MRI of the brain.
  • Use of certain medications that affect drug metabolism.
  • Ongoing use of high-dose steroids for brain metastases.
  • Uncontrolled seizures or history of whole brain radiation.
  • Active infection requiring IV therapy.
  • Pregnant or breastfeeding.
  • Recent treatment with another investigational drug.

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