Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer

Inclusion Criteria

• •Signed informed consent form;
• •Histologically verified diagnosis of stage IIb/III/IV breast cancer;
• •Age of 18-70 years inclusive;
• •If the patient had received the chemotherapy for breast cancer, it should be finished 30 days before the beginning of the study;
• •ECOG Performance Status of 0, 1 or 2, not increasing within during 2 weeks before randomization;
• •ANC level of 1500/μL and more at the beginning of the study
• •Platelet count of 100 000/μL and more at the beginning of the study
• •Hemoglobin level of 90 g/l and more
• •Creatinine level \<1.5 mg/dl
• •Total bilirubin level \<1.5 × the upper limit of normal (ULN)
• •ALT and/or AST levels \<2.5×ULN (5×ULN for patients with liver metastases);
• •Alkaline phosphatase \<5×ULN;
• •Left ventricular ejection fraction \>50% and more;
• •If the patient had received adjuvant and/or neoadjuvant therapy, the cumulative dose of anthracyclines should not exceed 500 mg/m2 for doxorubicin or 500 mg/m2 for epirubicin;
• •Ability of the participant to follow the protocol requirements, according to the Investigator's opinion;
• •Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior randomization and for 6 months after the last administration of the study drug.