Evaluation of BAY59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients

Inclusion Criteria:

• Female patients with a proven diagnosis of metastatic breast cancer
• Measurable disease as defined by the presence of at least one measurable lesion
• Patients must have received at least 3 weeks of continuous therapy with Taxane
• patient must subsequently develop progressive disease either during treatment or within 6 months after treatment
• Patients who failed on hormone therapy
• Life expectancy of at least 12 weeks.
• Adequate bone marrow, liver and kidney function
• Patients with active brain metastases may be included

Exclusion Criteria:

• Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia; surgery within 4 weeks of study entry; serious infections; HIV infection; chronic hepatitis B or C; patients with brain metastases must be without a seizure; hypersensitivity to taxanes; organ transplants; some previous cancers
• Excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant
• Others: pregnant or breast-feeding patients; women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.