Study of the Safety and Leukostimulatory Activity of the Preparation "Panagen" in Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Panagen; Placebo; Chemotherapy
Intervention description: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this trial is to assess the safety, therapeutic dose, and leukostimulatory
      activity of the preparation Panagen in the therapeutic schemes for treating cancer diseases
      in the patients receiving a standard chemotherapy for breast cancer of stages II-IV (with
      distant metastases).
    

Eligibility criteria:

        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