Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.

Inclusion Criteria: * Female patients aged between 18 - 65 years. * Patients with histological confirmed primary invasive breast cancer; stage I, II or III. * Patients had no prior chemotherapy treatments. * Patients scheduled to undergo myelosuppressive Doxorubicin and Cyclophosphamide chemotherapy for 04 cycles, and Paclitaxel chemotherapy for the next 04 cycles; patients were available for 14 days of each cycle for the first 03 chemotherapy cycles. * Patients with baseline ANC ≥ 1.5 x 109/L, PLT ≥ 100 x 109/L, HgB ≥ 9 g/dL, WBC ≥ 3,000/mL and albumin ≥ 3.0 g/dL. * Performance status as per ECOG (Eastern Cooperative Oncology Group) score 0, 1 or 2. * Willing to give written and signed informed consent. Exclusion Criteria: * Patients with prior exposure of G-CSF or GM-CSF or its pegylated products in clinical development less than 6 months prior to randomization. * Myelotoxic concomitant treatment such as chloramphenicol, methotrexate, immunomodulating agents, interferons during 10 days before randomization. * Received systemic antibiotic treatment within 72 hours of chemotherapy. * Chronic use of corticosteroids, prior bone marrow or stem cell transplant. * Patients who had an immediate/ concurrent exposure to radiotherapy or surgery (within 4 weeks). * Severe medical disease: cardiovascular, hepatic, renal, pulmonary… * Known cases of hematological disease (sickle cell anemia, AML…) * History of HIV positive, active hepatitis. * Pregnant and lactating women or patients planning to become pregnant. * Known allergic reactions to study medications. * Positive to anti-pegfilgrastim antibody test