Investigational Scan for Imaging HER2+ Breast Cancer with Brain Metastasis

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05376878

Provider View

This study is testing a new type of scan to see if it can help find HER2+ breast cancer that has spread to the brain and predict how well it might respond to a specific chemotherapy treatment.

Patient Parameters

Program Overview

This clinical trial is exploring a new scan called 64Cu-DOTA-trastuzumab PET/MRI to see if it can help detect HER2+ breast cancer that has spread to the brain. The scan may also help determine if the cancer in the brain absorbs a drug called trastuzumab, which could indicate how well the cancer might respond to a standard chemotherapy treatment called trastuzumab deruxtecan.

Description

The main goals of this study are to see if the new scan, 64Cu-DOTA-trastuzumab PET, is feasible for patients with HER2+ breast cancer that has spread to the brain, and to find out if patients who respond well to the chemotherapy drug trastuzumab deruxtecan show higher uptake in the scan compared to those who do not respond as well.

Additionally, the study will look at whether the lowest uptake value in the brain lesions is linked to how long it takes for the cancer to progress in the brain.

Study Process:

  • Patients will receive an infusion of trastuzumab on the first day.
  • The next day, they will receive the investigational scan using 64Cu-DOTA-trastuzumab and undergo a PET/MRI scan.
  • Patients will have follow-up brain MRI scans every 6 weeks for 24 weeks, and then every 9 weeks until the cancer progresses.
  • If the cancer does not progress or cause unacceptable side effects, patients will receive trastuzumab deruxtecan every 21 days.

Eligibility Criteria

Inclusion Criteria

  • Women with HER2+ breast cancer that has spread to the brain.
  • Age over 18 years.
  • Good overall health with an ECOG score of 0 to 2.
  • Patients with cancer in the brain's lining (leptomeningeal disease) can participate.
  • Planned treatment with trastuzumab deruxtecan.
  • Heart function must be above 50%.
  • Adequate blood cell counts and liver function.
  • Kidney function must be above 30 ml/min.
  • Previous treatment for brain cancer is allowed if at least one lesion is larger than 1.5 cm on an MRI scan.

Exclusion Criteria

  • Immediate need for treatment of brain metastases.
  • Lung disease or inflammation requiring steroids.
  • Significant eye disease affecting the cornea.
  • Recent heart attack (within 6 months), heart failure, unstable chest pain, or serious heart rhythm problems.

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