The pivotal BE study was a randomized, open label, two period, single dose, crossover study of PICS and Abraxane in subjects with locally recurrent or metastatic breast cancer. A total of 142 patients were randomized to characterize the pharmacokinetic (PK) profile of PICS for both unbound and total paclitaxel compared with Abraxane. The study also provided information on the safety profile of PICS.
The study met all the required pharmacokinetic endpoints for both unbound and total paclitaxel. There were no new adverse events observed in this study.
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