Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer

Exclusion Criteria

• •1. Subjects with active and inactive hepatitis, patients with history of HIV, or other uncontrolled infectious disease.
• •2. Subjects with a history of HIV positive or currently undergoing/received antiretroviral therapy, and subjects with a history of hepatitis B surface antigen positive, or current positive hepatitis C disease.
• •3. Subjects who received radiation therapy within 4 weeks prior to assignment to treatment group.
• •4. Subjects who have been diagnosed within 5 years with other types of cancer except for those who have been appropriately treated for superficial non-melanoma skin cancer or cervical intraepithelial neoplasia.
• •5. Subjects with a history of intolerance for granulocyte colony stimulating factor treatment
• •6. Subjects who are expected to show hypersensitivity to the IP or its ingredients
• •7. Subjects with a positive urine pregnancy test result at screening visit or before the first administration of the study drug
• •8. Subjects who took any other investigational product in other clinical study within 30 days prior to screening visit.
• •9. Clinically significant unstable medical abnormality; psychiatric disorder, chronic disease, alcohol or drug use disorder, or other significant biological, psychological, or social factor, which in the investigator's opinion, unfavorably affects the risk-benefit ratio of study participation or likely to affect study results.
• •10. Subjects with heart disease (i.e. congestive heart failure, arrhythmia, symptomatic coronary artery disease); Myocardial infarction within 6 months before initiation of the study.
• •11. Subjects with left ventricular ejection fraction (LVEF) \< 50% at screening.
• •12. Significant neurological or psychiatric disorders including dementia or seizures.
• •13. Patients with dyslipidemia not controlled by drugs \[based on LDL-C and TG levels for which treatment is recommended by the Korean dyslipidemia treatment guidelines and the U.S. National Cholesterol Education Program-Adult Treatment Panel III\]
• •14. Uncontrolled diabetes mellitus (HbA1c \>7%; if the level is confirmed after 6 months or longer treatment with oral hypoglycemic agents or insulin)
• •15. Subjects who have received systemic chemotherapy with doxorubicin to treat metastatic or recurrent breast cancer
• •16. Subjects with grade 2 or higher peripheral sensory neuropathy at screening visit or before the first dosing of the study drug
• •17. Subjects who have undergone significant gastrectomy along with intractable nausea and vomiting, chronic gastrointestinal disease, or clinically significant sequelae, which would interfere with proper absorption of the study drug
• •18. Subjects who administered systemic antibiotics within 14 days prior to administration of the study drug
• •19. Subjects whose cumulative dose of doxorubicin exceeded 240 mg/m2
• •20. Subjects who were currently receiving trastuzumab