Evaluation of Safety and Efficacy of TOCOSOL(R) Paclitaxel as Initial Treatment for Metastatic Breast Cancer

Exclusion Criteria

• •Any prior taxane-containing chemotherapy including Taxol or Taxotere
• •Patients who are pregnant or lactating
• •Peripheral neuropathy NCI-CTC grade 2 or greater
• •Wide-field radiation, hormonal therapy or trastuzumab within 4 weeks of first dose of study drug; cytotoxic chemotherapy within 6 months of first dose of study drug
• •Treatment with an investigational agent within 4 weeks of first dose of study drug
• •Patients with a history of carcinomas of primary sites which can not be distinguished histologically from metastatic breast carcinoma
• •Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic breast carcinoma
• •Brain metastases
• •Active bowel obstruction
• •Active, serious infection or other serious medical problems (other than metastatic breast cancer) likely to impair completion of the study protocol
• •Concurrent therapy with known substrates or inhibitors of the cytochrome P450 isoenzymes CYP2C8 or CYP3A4
• •Concurrent therapy with warfarin or other coumarin derivatives