Feasibility study of cationic liposome-encapsulated paclitaxel in combination with paclitaxel followed by FEC as induction therapy in HER2-negative breast cancer

2013 
e12008 Background: Cationic liposome-encapsulated paclitaxel , a tumor endothelial targeting agent (composition of paclitaxel combined with neutral and cationic lipids) has shown activity in metastatic triple-negative breast cancer (BC) in combination with paclitaxel (Awada et al. ESMO2010). No data exist in the non-metastatic setting. Methods: HER2-negative BC candidates for neoadjuvant chemotherapy were scheduled to receive 12 cycles of weeklycationic liposome-encapsulated paclitaxel 22mg/m2 plus paclitaxel 70mg/m2 followed by 3 cycles of FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2) every 3 weeks followed by surgery. Primary endpoint was percent (%) reduction in Magnetic Resonance Imaging (MRI) estimated tumor volume at the end of cationic liposome-encapsulated paclitaxel plus paclitaxel administration as compared to baseline. Safety, pathological complete response (pCR) defined as no residual tumor in breast and axillary nodes at surgery and correlation between % reductio...
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