Study on Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab for HER2+ Breast Cancer Spread to the Brain and Spinal Fluid

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04588545

Provider View

This clinical trial is exploring whether radiation therapy followed by direct administration of trastuzumab and pertuzumab into the spinal fluid is safe and can improve survival in patients with HER2 positive breast cancer that has spread to the brain and spinal fluid.

Patient Parameters

Program Overview

The study aims to determine if a combination of radiation therapy and direct administration of trastuzumab and pertuzumab into the spinal fluid can help patients with HER2 positive breast cancer that has spread to the brain and spinal fluid. The treatment starts with radiation therapy to the whole brain or specific areas, followed by the administration of trastuzumab and pertuzumab directly into the spinal fluid.

Description

This study is a phase I/II trial designed to test the safety and effectiveness of using radiation therapy followed by direct administration of trastuzumab and pertuzumab into the spinal fluid for treating HER2 positive breast cancer that has spread to the brain and spinal fluid. The treatment begins with radiation therapy, which may include whole brain radiation or targeted radiation to specific areas of the brain or spine. After radiation, trastuzumab and pertuzumab are administered directly into the spinal fluid to target cancer cells more effectively. The study is open to patients with confirmed HER2 positive breast cancer and leptomeningeal disease, which means the cancer has spread to the membranes surrounding the brain and spinal cord. Participants may also have brain metastases and must meet specific health criteria to join the study. The trial aims to improve survival rates and assess the safety of this treatment approach.

Eligibility Criteria

Inclusion Criteria

  • Confirmed HER2 positive breast cancer with spread to the brain and spinal fluid.
  • May have brain metastases.
  • Must provide a sample of spinal fluid or have MRI evidence of disease.
  • Life expectancy of more than 8 weeks.
  • Consent to a tumor biopsy or provide previous tissue samples.
  • Normal kidney, liver, and blood function.
  • Heart function above 50%.
  • General health score of 60 or higher.
  • Recovery from any recent surgery within 14 days.
  • No limit on previous treatments.
  • Willing to have a device placed for drug administration.
  • Use effective birth control during and after the study.
  • Ability to provide informed consent.
  • May continue other treatments if they control the disease.

Exclusion Criteria

  • Participation in another study within 2 weeks before starting this treatment.
  • Cannot be on certain chemotherapy drugs unless the disease progresses while on them.
  • Recent major surgery or injury not fully healed.
  • Severe lung disease causing shortness of breath at rest.
  • Pregnant or breastfeeding women.
  • History of severe reactions to study drugs.
  • Cannot receive whole brain radiation while on this treatment, but targeted radiation is allowed.
  • Significant medical or mental health issues that prevent following the study plan.

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