A post marketing surveillance trial to study the safety and efficacy of two drugs, Neupeg and Neulastim in female patients with advanced breast cancer

INTERVENTION: Intervention1: Peg Filgrastim: 6mg/0.6ml Control Intervention1: Neulastim: 6mg/0.6ml CONDITION: Advanced(Stage III & IV) Breast Cancer PRIMARY OUTCOME: The primary efficacy endpoint will be‐‐‐‐‐‐Timepoint: Duration of severe Neutropenia (defined as ANC < 0.5 × 109/L) SECONDARY OUTCOME: Secondary efficacy endpoints‐‐‐‐‐‐Timepoint: ?Depth of ANC count(nadir) in each cycles as compared to baseline; ?Incidence of Febrile Neutropenia ? (Defined as a rise in axillary temperature to >38.5 °C for a duration of more than 1 hour while having an absolute neutrophil count < 0.5 × 109 /l); ?Incidence of severe Neutropenia(defined as ANC < 0.5 × 109/L) ; ?Time to ANC recovery; ?Use of Antibiotics for the treatment of Febrile Neutropenia; INCLUSION CRITERIA: 1.Female Patients aged 18 years and above suffering from advanced (Stage III and IV) Breast Cancer eligible for receiving AT (Docetaxel‐ 75 mg/m2, Doxorubicin‐ 50 mg/m2) chemotherapy. 2.GCSF and Peg‐ GCSF naive patients 3.ANC > 1,500/uL 4.Hemoglobin > 9 g/dL 5.Platelets > 100,000/ul 6.Patients with serum creatinine ≤ 1.5 mg/dL 7.AST/ALT < 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, Bilirubin ≤ 2 x ULN 8.Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study 9.Patients able to adhere to the study visit schedule and other protocol requirements 10.Completion of previous chemotherapy more than 4 weeks before randomization