Tesmilifene in Combination With Docetaxel in the Treatment of Metastatic Breast Cancer

Primary Objective: 1\. To evaluate whether the co-administration of a fixed dose of tesmilifene (5.3 mg/kg) with a standard dose of docetaxel (100 mg/m2) alters the plasma pharmacokinetics of docetaxel compared to the pharmacokinetics of docetaxel when given alone. Secondary Objectives: 1. To correlate plasma tesmilifene levels during and following the infusion with the acute tesmilifene-related adverse events observed during and after the infusion. 2. To collect safety information for tesmilifene when administered in combination with docetaxel. 3. To evaluate response rate, duration of response and overall survival in metastatic breast cancer patients receiving docetaxel plus tesmilifene.