Pyrotinib Combined With Brain Radiotherapy in Breast Cancer Patients With Brain Metastases

Inclusion Criteria

• •1. Pathologically confirmed HER2 positive advanced breast cancer
• •2. Age\>18 years. brain metastases confirmed by enhanced brain MRI
• •3. KPS≥70
• •4. Life expectancy of more than 12 weeks
• •5. Prior therapy of oral dexamethasone not exceeding 16mg/d
• •6. Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1.
• •7. Maximum diameter of intracranial metastases is less than 3cm measured by enhanced brain MRI(2-3mm)
• •8. Prior endocrine therapy were allowed
• •9. Anti-Her2 targeted treatment were allowed
• •10. Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):
• •1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L
• •2. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases
• •3. Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN)
• •4. LVEF ≥ 50%
• •5. QTcF \< 480 ms
• •6. INR≤1.5×ULN，APTT≤1.5×ULN
• •11. Signed the informed consent form prior to patient entry