Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer

Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer

The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Inclusion Criteria:

• Metastatic breast cancer
• No previous treatment with taxanes, and vinca alkaloids
• Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

• More than 2 previous chemotherapies
• Previous participation in another trial within the last 4 weeks
• Breast feeding
• Active infections