Efficacy and Safety Study With MYL-1401H and Neulasta

Exclusion Criteria

• •Participation in a clinical trial in which they received an investigational drug within 28 days before randomization.
• •Previous exposure to filgrastim, pegfilgrastim, lenograstim, lipegfilgrastim, or other filgrastim forms on the market or in clinical development.
• •Received blood transfusions or erythroid growth factors within 2 weeks prior to first dose of chemotherapy.
• •Known hypersensitivity to any drugs or excipients that patients will be receiving during the study.
• •Known hypersensitivity to E. coli-derived products.
• •Known fructose intolerance (related with sorbitol excipient).
• •Underlying neuropathy of grade 2 or higher.
• •Active infectious disease or any other medical condition which might put the patient at significant risk to tolerate 6 courses of TAC chemotherapy (e.g., recent myocardial infarction).
• •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × Upper limit of normal (ULN), ALT and/or AST \> 1.5 × ULN with alkaline phosphatase (ALP) \> 2.5 × ULN; any bilirubin \> ULN.
• •Treatment with systemically active antibiotics within 5 days before first dose of chemotherapy.
• •Patients under treatment with lithium.
• •Chronic use of oral corticosteroids.
• •Splenomegaly of unknown origin by physical examination and/or computerized tomography scan or ultrasound and any condition which can cause splenomegaly, e.g., thalassemia, glandular fever, hemolytic anemias, and malaria.
• •Myeloproliferative or myelodysplastic disorders, sickle cell disorders, and any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint.
• •Increase potential risk of Adult Respiratory Distress Syndrome.
• •Pregnant or nursing women.
• •Patients known to be seropositive for human immunodeficiency virus (HIV), or who have had an acquired immunodeficiency syndrome (AIDS) defining illness or a known immunodeficiency disorder.
• •A known active abuse of drugs or alcohol should preclude patient participation and evaluation in the study.
• •Any known psychiatric conditions.
• •Any disease or physical condition that may not allow for the adequate performance of study assessments, such as lack of access to patient's domiciliary, and distance of patient's domiciliary from clinic site.