- Diagnosis of advanced breast cancer.
- Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
- No prior treatment with cytotoxics in the advanced disease setting.
- HER2/neu positive disease unless trastuzumab was previously received or is
- Treatment with a taxane in the adjuvant setting unless disease free interval >12
months after end of treatment.