ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases

Inclusion Criteria:

• Patients must have histologically or cytologically invasive breast cancer, with metastatic disease at the time of screening
• Measurable Central Nervous System (CNS) disease, as defined as at least one lesion > or equal too 10mm in longest dimension
• New or progressive CNS lesions after at least one prior standard CNS-directed therapy for treatment of brain metastases, which could include surgical resection, whole brain radiotherapy (WBRT), and/or stereotactic radiosurgery (SRS). Patients must have received prior WBRT, SRS or both.
• Patient has been evaluated by a radiation oncologist, who feels that the plan to evaluate systemic chemotherapy in place of additional brain radiotherapy is an acceptable option
• No increase in corticosteroid use in the week prior to study entry
• Any number prior lines of chemotherapy for metastatic breast cancer
• 18 years of age of older
• Life expectancy of greater than 12 weeks
• ECOG Performance Status 0-2
• Patients must have normal organ function as outlined in the protocol

Exclusion Criteria:

• Patients who have had chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
• Patients who have had XRT within 3 weeks prior to entering the study or those who have not recovered from adverse events due to XRT
• Patients may not be receiving any other investigational agent
• Patients may not be receiving any cancer-directed therapy
• Prior treatment with investigational chemotherapy for brain metastases
• Prior treatment with epothilone for metastatic breast cancer
• Leptomeningeal carcinomatosis as the only site of CNS involvement.
• Concurrent treatment with an enzyme inducing antiepileptic drug, including phenytoin, carbamezepine, phenobarbital, or oxacarbazepine
• More than 2 seizures over the last four weeks prior to study entry
• Known contraindication to MRI or gadolinium contrast, such as cardiac pacemaker, ocular foreign body, or shrapnel
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or breastfeeding women.