Study Evaluating Hemay022 In Subjects With HER2-Positive Advanced Breast Cancer

Inclusion Criteria

• •1. Male or female subjects aged 18 to 65 years;
• •2. Histologically or cytologically confirmed and radiologically diagnosed advanced breast cancer subjects; and subjects who have failed standard therapy，or no effective therapy available for such subjects
• •3. HER2 over-expression by IHC with score of 3+, or 2+ with FISH confirmation;
• •4. Preferably measurable tumour lesion as defined by RECIST criteria1.1;
• •5. Subjects have received chemotherapy at least 4 weeks prior to screening (at least 6 weeks of washout time frame if treated with mitomycin and nitrosoureas) and must have recovered from any toxic effects of the treatment --- to CTCAE 4.03≤ Grade 1;
• •6. ECOG Performance Status of 0,1;
• •7. Life expectancy of at least three months;
• •8. Adequate bone marrow, liver, kidney function, meeting the following creteria:
• •ANC≥1.5×109/L, HB≥90g/L, PLT≥75×109/L； TBIL≤1.5×ULN, ALT≤1.5×ULN, AST≤1.5×ULN; Cr ≤1×ULN; BUN ≤1×ULN;
• •9. Left ventricular ejection fraction (LVEF) ≧50% as measured by Ultrasonic cardiogram (UCG)
• •10. All female and male subjects must agree and commit to the use of a reliable contraceptive regimen for the duration of the study and for at least 12 weeks after at the last dose of test article. Female subjects must have a negative serum or urine pregnancy test performed within 7 days prior to treatment;
• •11. Ability to understand and the be willingness to sign a written informed consent before study entry;
• •12. subjects would have good communication with the investigator and could comply with protocol