A randomized, double-blind, parallel-group, multi-center Phase III study comparing the efficacy and safety of EP2006 and Neupogen� in breast cancer patients treated with myelosuppressive chemotherapy
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Last updated:2nd Nov 2011
To assess the efficacy of EP2006 compared to Neupogen� (US-licensed) with respect to the mean duration of severe neutropenia (DSN), defined as the number of consecutive days with Grade 4 neutropenia (absolute neutrophil count [ANC] less than 0.5 x 10 9/L), during Cycle 1 of the neoadjuvant or adjuvant TAC regimen (Taxotere� [docetaxel 75 mg/m2] in combination with Adriamycin� [doxorubicin 50 mg/m2] and Cytoxan� [cyclophosphamide 500 mg/m2]) in breast cancer patients.
|Study start date||2011-11-02|