An Uncontrolled Phase II Study Evaluating the Efficacy and Safety of Intravenous BAY59-8862 in Patients With Taxane-Resistant Metastatic Breast Cancer

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.