Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF

Study Stage: Phase II/III Study Population Female patients with breast cancer will be enrolled to receive at least 4 cycles of TC chemotherapy, that is: Docetaxel 75 mg/m2 and Cyclophosphamide 600 mg/m2. Study Design: A multi-center, randomized, open-label, active-controlled phase II/III clinical trial

A Phase II/III,Multi-Center,Randomized,Double-blind,Active-Controlled Trial to Compare the Efficacy , Safety and Immunogenicity of MW05 and PEG-rhG-CSF in Prophylactic Treatment for Chemotherapy-Induced Neutropenia

In the study, subjects will scheduled to undergo four 21-days cycles of chemotherapy treatment. Three group were treated with MW05 300 ?g/kg or MW05 500 ?g/kg or PEG-rhG-CSF 100 ?g/kg on the 3th day of each cycle randomized 1:1:1 . The dose of the experimental drug MW05 in phase III were determined by independent data monitoring committee (IDMC) according to the efficacy and safety of phase II. Subjects were randomly divided into two groups 1:1 to received either MW05 or PEG-rhG-CSF(100 ?g/kg) on the 3th day of each chemotherapy cycle.

Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF

Recruitment

Summary

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