Study on Efficacy and Safety of CBLB612 for Neutropenia Prophylaxis

Inclusion Criteria

• •1. Written informed consent for the study participation.
• •2. Women in the age above 18 years inclusively.
• •3. Patients with histologically proven diagnosis of breast cancer to which the 1-st cycle of AC chemotherapy treatment is indicated (with 3-week interval).
• •4. ECOG Performance Status of 0-2.
• •5. Life expectancy ≥ 6 months.
• •6. Completion of all previous cancer therapies (including surgery, radiotherapy, chemotherapy, immunotherapy or study therapy) not later than 4 weeks prior the CBLB612 study.
• •7. All acute toxic effects of any previous therapies \<Grade 1 prior the study, except for alopecia and/or neurotoxicity (Grade 1 or 2 is allowed).
• •8. Adequate hematopoiesis function:
• •* WBC ≥3.0 x 103/μl;
• •* PTT ≥1.5 x 103/μl;
• •* Platelets ≥75 x 103/μl;
• •* Hemoglobin ≥10 g/dl.
• •9. Adequate hepatic function:
• •* Total bilirubin ≤1.5 x ULN;
• •* ALT and AST ≤3 x ULN;
• •* Alkaline phosphatase ≤2.5 x ULN.
• •10. Adequate renal function:
• •* Creatinine ≤1.5 x ULN.
• •11. Adequate values of hemostasis system:
• •* Prothrombin time;
• •* ≤1.5 x ULN;
• •* Activated partial thromboplastin time ≤1.5 x ULN;
• •* INR ≤1.5 x ULN.
• •12. Adequate cardiac function which means
• •* LVEF ≥45 based on ultrasonic examination of the heart or radionuclide angiography;
• •* 12-lead electrocardiogram (ECG) with normal tracing, non-clinically significant changes may occur that do not require medical intervention.
• •13. Negative test for serological infection markers:
• •* Negative HIV-antibody test;
• •* Negative test for hepatitis B surface antigen (HBsAg);
• •* Negative test for hepatitis C virus antibodies or negative test for mRNA of hepatitis C virus;
• •* Negative test for Treponema pallidum antibodies.
• •14. Negative pregnancy test.
• •15. Consent of a patient with preserved reproductive function to use effective contraception method since screening up to at least 3 months after the study therapy.
• •* e.g. intrauterine device, oral contraceptive, subcutaneous implant or double-barrier method (condom with contraceptive sponge or contraceptive vaginal suppository).
• •16. A patient shall be ready and able to meet the requirements of the study protocol and have the opportunity to participate in the study throughout the scheduled period.