A multicenter phase II randomized study of Cremophor‐free polymeric nanoparticle formulation of paclitaxel in women with locally advanced and/or metastatic breast cancer after failure of anthracycline

Paclitaxel is extensively used in the treatment of advanced carcinomas of the breast, ovary and non‐small cell lung cancer. In clinical use it is formulated in the non‐ionic surfactant polyethoxylated castor oil (Cremophor) and dehydrated alcohol to enhance drug solubility. Cremophor adds to toxic effects of paclitaxel by producing or contributing to the well‐described hypersensitivity reactions that commonly occur during its infusion, affecting a large number of patients. This randomized trial was conducted to evaluate efficacy and safety of novel nanoparticle‐based paclitaxel in the treatment of patients with advanced breast cancer.