Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.

Inclusion Criteria

• •Female patients aged 18 to 70 years old.
• •Patients diagnosed having high risk stage 2 or stage 3 or 4 of breast cancer (by histopathological or cytological diagnosis) and need neoadjuvant, adjuvant chemotherapy, or with metastatic disease.
• •A priori has been decided to be treated with Peg-Filgrastim and subjects eligible for Peg-Filgrastim therapy according to indications and clinical use in the product monograph
• •Patients scheduled to receive 4 or 6 cycles of chemotherapy (Taxane combinations) with prophylactic Peg-Filgrastim at 3 weeks interval. Monoclonal Antibodies in addition to Taxane regimens are permitted.
• •Any acute adverse effects of prior therapy must have resolved to ≤ NCI CTCAE (Version 4.0) grade 1 (excluding alopecia) prior to Day 1 of Cycle 1
• •Eastern Cooperative Oncology Group - ECOG Performance Status 0, 1 or 2 as determined on Day 1 or up to -3 of Cycle 1 prior to administration of chemotherapy
• •Patients must have adequate organ function including the following:
• •1. Adequate bone marrow functions, as determined within 3 days prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by Hb ≥9,5 g/dl (transfusion permitted to be included in the trial ),WBC (white blood cell) ≥3,5 x 109/l, Absolute neutrophil count (ANC) ≥1.5 x 109/l, Platelets ≥95 x 109/l;
• •2. Adequate renal and hepatic function, as determined within 3 days prior to administration of chemotherapy on Day 1 of Cycle 1 and defined as follows,
• •1. Hepatic: Bilirubin ≤ 1.5 x the upper limit of normal (ULN) (unless elevation is known to be due to Gilbert's disease), Subjects must also meet one of the following criteria:
• •1. Alkaline phosphatase within normal reference range and both AST (aspartate aminotransferase) and ALT (alanine aminotransferase) \>2.5 x ULN; or
• •2. Alkaline phosphatase \<2.5 x ULN and both AST and ALT \<1.5 x ULN; or
• •3. Alkaline phosphatase \<5 x ULN and both AST and ALT within normal reference range;
• •2. Renal: Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≤ 60 ml/min (calculated according to the Cockcroft and Gault formula)
• •Patients of child-bearing potential must have a negative pregnancy test within 3 days prior to the first dose of chemotherapy and at day 1 or up to -3 days of each Cycle) and use at least one form of contraception as approved by the investigator during the study.
• •Life expectancy \>6 months