A Phase I/II Study of Intrathecal Trastuzumab in Women with HER2-Positive Breast Cancer that Spread to the Spinal Fluid

Protocol
12-123
Full Title
Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer
Phase
I/II
Purpose

Trastuzumab (Herceptin) is approved for treating breast cancers that produce high levels of a protein called HER2. It is typically given intravenously. However, when the cancer spreads to the brain or spinal cord, trastuzumab is unable to pass through the blood-brain barrier to kill cancer cells.

In this study, researching are determining the highest level of trastuzumab that can be delivered directly into the spinal fluid in women whose HER2-positive breast cancer spread to that area (what is called “leptomeningeal disease”).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have HER2-positive breast cancer that has spread to the spinal fluid.
  • At least 2 weeks must have passed since completion of any prior radiation therapy and entry into the study.
  • There is no limit on the number of prior systemic therapy regimens.
  • Patients must be age 18 or older.
Disease(s)
Breast Cancer
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