Randomized Study Comparing Nab-Paclitaxel With Solvent- Based Paclitaxel In Chinese Patients (Pts) With Metastatic Breast Cancer (Mbc)

1038 Background: The results of a large clinical study comparing solvent-based paclitaxel 175 mg/m2 with 130-nM albumin-bound paclitaxel (nab-paclitaxel) 260 mg/m2 demonstrated that nab-paclitaxel had greater efficacy and a favorable safety profile in pts with MBC (Gradishar et al., JCO, 2005; 23:7794). The maximum tolerated dose of nab-paclitaxel was 300 mg/m2 infused over 30 minutes without premedication in Chinese pts with solid tumors (Teng et al., Ai Zheng, 2004;23:1431). The aim of this randomized study is to compare the response rates and to evaluate the safety of nab-paclitaxel with those of solvent-based paclitaxel in Chinese pts with MBC. Methods: In this open-label, multicenter study, 210 pts with MBC were assigned to either solvent-based paclitaxel 175 mg/m2 intravenously (IV) over 3 hours every 3 weeks (q3w) with standard premedication (steroids and antihistamines) or nab-paclitaxel 260 mg/m2 IV over 30 minutes q3w with no premedication for 1–6 cycles. The primary endpoints were the overall r...