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 (byhistopathological or cytological diagnosis) and need neoadjuvant, adjuvantchemotherapy, or with metastatic disease.

• A priori has been decided to be treated with Peg-Filgrastim and subjects eligible forPeg-Filgrastim therapy according to indications and clinical use in the productmonograph

• Patients scheduled to receive 4 or 6 cycles of chemotherapy (Taxane combinations) withprophylactic Peg-Filgrastim at 3 weeks interval. Monoclonal Antibodies in addition toTaxane 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 determinedon 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 toadministration of chemotherapy on Day 1 of Cycle 1 and as indicated by Hb ≥9,5g/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 toadministration of chemotherapy on Day 1 of Cycle 1 and defined as follows,

3. Hepatic: Bilirubin ≤ 1.5 x the upper limit of normal (ULN) (unless elevationis known to be due to Gilbert's disease), Subjects must also meet one of thefollowing criteria:

4. Alkaline phosphatase within normal reference range and both AST (aspartate aminotransferase) and ALT (alanine aminotransferase) >2.5 xULN; or

5. Alkaline phosphatase <2.5 x ULN and both AST and ALT <1.5 x ULN; or

6. Alkaline phosphatase <5 x ULN and both AST and ALT within normalreference range;

7. 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 daysprior 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 thestudy.

• Life expectancy >6 months

Exclusion Criteria: Safety of treatment dependent criteria:

• Presence of any serious concomitant systemic disorders incompatible with theadministration of filgrastim, Peg-Filgrastim or any systemic disease that caninfluence the patient's safety according to doctor's diagnosis.

• History of hypersensitivity to Peg-Filgrastim, filgrastim or E.coli derived proteins.

• Serious local infection or active systemic infection within 10 days prior toenrollment or patients who have taken antibiotics within the previous 10 days

• Pregnant or breast-feeding patients

• Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable oradvanced ischemic heart disease (NYHA III or IV)

• Known bleeding disorder

• Patient known to have HIV, Hepatitis B, Hepatitis C or who have a positive serologyfor HIV, Hepatitis B or Hepatitis C at screening

• History or presence of sickle cell disease

• Concurrent or prior radiotherapy within four weeks of randomization Criteria dependent on compliance with study procedures, or the evaluation of the response:

• Unwilling to use a reliable and acceptable contraceptive method throughout the studyperiod (fertile patients only)

• Treatment with certain other agents to treat the malignant disease

• Known drug addiction, including alcoholism

• Treatment with any investigational product within 30 days prior to study drugadministration

• Concurrent prophylactic antibiotics

• Previous participation in this study.

• Already involved in another trial.

• History of bone marrow or stem cell transplantation.

• Previous therapy should not have included G-CSF (granulocyte-colony stimulatingfactor) Previous participation in this study: Subjects who are considered screening failures areallowed to be re-screened, except if have started chemotherapy. In case of re-screening thefollowing assessments and evaluations do not have to be repeated: Demographics, Medicalhistory, HIV, Hepatitis B and C serology.