GCPGC in Chemotherapy-induced Neutropenia

A Randomized,Multi-center,Parallel-group, Phase II(Single-blind)/Phase III(Double- Blind)Study to Determine the Optimal Dose and to Evaluate the Efficacy and Safety of GCPGC on Chemotherapy-induced Neutropenia Compared to Neulasta(Pegfilgrastim)

This study is adaptive design and it consists of stage I and stage II.

Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia. 2 Different doses of GCPGC will be investigated in a total of 60 Breast cancer patients who are receiving chemotherapy.

Stage II is multi-center, parallel-group, double-blind,phase III study to evaluate the efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to Neulasta (pegfilgrastim). A total of 120 patients receiving chemotherapy will participate into this phase.

GCPGC ia a solution for containing pegfilgrastim. Pegfilgrastim is a covalent conjugate of recombinant human granulocyte colony-stimulating factor (G-CSF) with a polyethylene glycol (PEG) which has long half life compared to filgrastim, resulting in dosing advantage.

Inclusion Criteria:

• women(≥ 18 years old) diagnosed with breast cancer who are receiving chemotherapy inducing neutropenia
• body weight of 45kg and more
• ECOG performance status 2 and less
• ANC ≥1,500mm3 and Platelet ≥100,000/mm3
• life expectancy of 3 months and more
• given written informed consent

Exclusion Criteria:

• had previous exposure to pegfilgrastim or filgrastim
• had received systemic antibiotics within 72hrs of chemotherapy
• prior total cumulative lifetime exposure to doxorubicin more than 240 mg/m or epirubicin more than 600 mg/m