Study of BCD-115 in Women With ER(+) HER2(-) Local Advanced and Metastatic Breast Cancer

Exclusion Criteria

• •1. HER2-positive tumour ;
• •2. Patients with unstable brain metastases, advanced, symptomatic, visceral spread disease, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions pleural, pericardial, peritoneal, pulmonary lymphangitis, and over 50% liver involvement).
• •3. Important cardiovascular events in the past 6 months to randomization;
• •4. GI diseases which may affect the absorption of the study drug;
• •5. Inadequate hematopoietic function: neutrophils ≤1500/mm3, platelets ≤100 000/mm3,or hemoglobin ≤90 g/L;
• •6. Inadequate renal function: creatinine level ≥ 1.5 × upper limit of normal (ULN);
• •7. Inadequate liver function: bilirubin level ≥ 1.5 × ULN, AST and ALT levels ≥ 2.5 × ULN (5 × ULN for patients with liver metastases), alkaline phosphatase level ≥ 5 × ULN;
• •8. Concurrent antitumor treatment 21 days before randomization (surgery, radiation therapy; chemotherapy, except endocrine therapy);
• •9. Any other concomitant cancer including contralateral breast cancer revealed within 5 years prior to screening, except curatively treated intraductal carcinoma in situ, curatively treated cervical carcinoma in situ or curatively treated basal cell or squamous cell carcinoma;
• •10. Conditions limiting patient's adherence to protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others);
• •11. Concomitant participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial;
• •12. Acute or active chronic infections;
• •13. HCV, HBV, HIV or syphilis infections;
• •14. Obstacles to p.o. administration of study drug.