Effectiveness and Safety Study of Filgrastine® in Patientes With Breast Cancer Treated With Myelotoxic Chemotherapy

Inclusion Criteria:

* Provision of the Free and Informed Consent Form by written;
* Female sex;
* Age between 18 and 75 years old;
* Diagnosis of breast cancer confirmed by cytology or histopathology;
* Disease in stages II or III, according to the classification tumor-node-metastasis (TNM);
* Indication of chemotherapy with full dose of one of the regimens eligible;
* Performance status of 0 or 1;
* Appropriate body functions (absolute neutrophil count \[CAN\] ≥1,500/mm³; platelet count ≥150,000/mm³; serum creatinine ≤1.2 mg/dL; bilirubin and transaminases ≤1.5 times the upper limit of normal).

Exclusion Criteria:

* Previous use of chemotherapy;
* Previous use of filgrastim;
* Prediction of prophylactic or therapeutic use of antibiotics, antifungals or antivirals in the first cycle of chemotherapy;
* Previous radiotherapy involving the pelvis or radiotherapy from any site within the last 6 weeks prior to randomization;
* History of bone marrow transplantation (as a recipient);
* Presence of other neoplasms;
* Presence of severe co-morbidities;
* Recent (\<6 months) or planned participation in other studies clinical trials involving drugs of any nature or in studies of any form of intervention;
* Known intolerance or allergy to any of the components the filgrastim formulations evaluated in the study;
* Pregnancy or lactation (patients of childbearing potential must have a negative serological pregnancy test dated within 7 days prior to randomization).