Study of the Safety and Leukostimulatory Activity of the Preparation "Panagen" in Patients With Breast Cancer

Inclusion Criteria:

* Signed and dated written informed consent
* Women at an age of ≥18 years
* Stage II-IV breast cancer (with distant metastases)
* The patients will be subject to chemotherapy with cyclophosphan/doxorubicin/ fluorouracil as a standard chemotherapy for treating breast cancer
* The patients have not been earlier subject to chemotherapy
* Functional status according to the Eastern Cooperative Oncology Group (ECOG) ≤2
* Leukocyte counts of ≥3 × 109/L before the treatment course
* Neutrophil counts of ≥1.5 × 109/L before the treatment course
* Platelet counts of ≥100 × 109/L before the treatment course
* Adequate heart function
* Adequate liver function, that is, alanine aminotransferase / aspartate aminotransferase (ALT / AST) activity \< 2.5 × upper limit of normal (ULN); acid phosphatase activity \< 5 × ULN; and bilirubin concentration \< 5 × ULN; and
* Adequate renal function, that is, the creatinine concentration in the blood serum \< 1.5 × ULN; urea concentration \< ULN; and endogenous creatinine clearance

Exclusion Criteria:

* Participation in clinical trials less than 30 days before sequential randomization
* Previous exposure to Panagen or any other leukostimulatory drugs at a stage of clinical development
* Known hypersensitivity to cyclophosphan, doxorubicin, or fluorouracil
* Therapy with systemically active antibiotics less than 72 h before the beginning of chemotherapy
* Long-term oral intake of corticosteroids
* Previous X-ray therapy performed less than 4 weeks before randomization
* Previous transplantation of hematopoietic stem cells
* Other malignant neoplasms during the last 5 years except for basal cell or flat cell carcinoma or intraepithelial carcinoma of the uterine cervix
* Any disease or state that according to the opinion of researcher can influence patient's safety or the estimation of a final trial point; and
* Pregnant and nursing women; the fertile patients should use chemical or barrier contraceptives during the period of trials