- Patients are required to have had at least one prior chemotherapy regimen for advanced breast cancer unless they have progressed within 12 months of concluding adjuvant chemotherapy; patients may not have had more than 2 prior chemotherapy regimens for advanced breast cancer; treatment with high-dose chemotherapy and stem cell support in the metastatic setting, including induction chemotherapy, will be considered 2 treatment regimens; patients may have received adjuvant chemotherapy; patients who have metastatic breast cancer diagnosed within 12 months of concluding adjuvant chemotherapy will be eligible after 0 or 1 regimens in the metastatic setting; patients may have received prior hormonal therapy of any type; patients may have been previously treated with investigational agents or biological agents (e.g. Herceptin)