Effect Of Nanosomal Docetaxel Lipid Suspension (Ndes) On Response Rate Compared To Docetaxel: A Randomized Phase Ii Study In Patients With Locally Advanced Or Metastatic Breast Cancer

577 Background: Docetaxel formulated inpolysorbate 80 and ethanol (Docetaxel) is among the most active agents in the treatment of breast cancer. The primary rationale for developing nanosomal docetaxel lipid suspension (NDLS) is to improve the drug’s safety profile by eliminating polysorbate 80 and ethanol from docetaxel formulation. Previously, we conducted a clinical study comparing pharmacokinetic parameters of NDLS and docetaxel at 75 mg/m2. The log transformed NDLS/docetaxel ratio for Cmax and AUC0-t was 149.3% and 119.3% respectively. The higher systemic availability of NDLS prompted us to conduct current efficacy study. Methods: 72 locally advanced or metastatic breast cancer patients were enrolled into the study after failure of prior chemotherapy. The mean age for the enrolled patients was 47 years and the racial make-up of the study was 100% Asian. Patients were administered NDLS or docetaxel at 75 mg/m2 as per randomization schedule, by IV infusion for one hour in each cycle of 21 days. Each pa...