Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study 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.