Lead Sponsor

Blau Farmaceutica S.A.

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

No

•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).

•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).

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