Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients

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.