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A Phase II Trial of Patupilone in Patients with Brain Metastases from Breast Cancer

[Protocol 07-036]


Full Title :
A PHASE II TRIAL OF PATUPILONE IN PATIENTS WITH BRAIN METASTASES FROM BREAST CANCER
Purpose :

The purpose of this study is to assess the safety and effectiveness of an investigational drug called patupilone in women with breast cancer that has spread to the brain.

Within cells, structures called microtubules are required for many cellular processes -- in particular, cell division (mitosis). Patupilone works by blocking mitosis, inhibiting the ability of cancer cells to divide and forcing them to commit suicide. Patupilone is similar to the approved anticancer drugs paclitaxel and docetaxel, but appears to be more potent.

Laboratory studies have suggested that patupilone can get into brain tissue. Currently, most drugs that are used to treat breast cancer are not effective against breast cancer that has spread to the brain. Patupilone may be active against both breast cancer within the body and in the brain.

Eligibility :

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

  • Patients must have breast cancer that has spread to the brain.
  • At least 3 weeks must have passed since completion of prior chemotherapy (2 weeks for targeted agents) and 4 weeks since radiation therapy and entry into the study. Patients may continue to take hormone therapy or trastuzumab during the study.
  • Patients must be age 18 or older.

For more information and to see if you are eligible for this study, please contact Dr. Andrew Seidman at 646-888-5445.

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