Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease

The purpose of this study is to find out if radiation therapy followed by intrathecal trastuzumab and pertuzumab is safe and will result in improved survival in HER2 positive breast cancer which has metastasized to the leptomeninges.

Trial Details

NCT ID
NCT04588545
Phase
PHASE1 / PHASE2
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Radiation Therapy
  • Pertuzumab
  • Trastuzumab
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843
  • Evanston, Illinois, United States|42.04114,-87.69006

Key Eligibility Criteria

  • Confirmation of HER2 positivity. All patients with HER2+ cancers will be allowed to enroll if they have leptomeningeal disease (LMD). Patients may …
  • And/or patients with HER2 positive cells in the cerebral spinal fluid.
  • Participants may have concomitant brain metastases
  • Cerebrospinal fluid (CSF) sampling is required to document LMD if not documented by MRI. Participants are still eligible CSF is negative but LMD di…

For full eligibility, visit ClinicalTrials.gov.

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