FSRT in Breast Cancer Patients With Brain Metastases

Inclusion Criteria:

• Histologically confirmed HER2 positive advanced breast cancer
• Age>18 years.
• 1 to 10 brain metastases confirmed by enhanced brain MRI
• KPS≥70
• Life expectancy of more than 12 weeks
• Prior therapy of oral dexamethasone not exceeding 16mg/d
• Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1.
• Maximum diameter of intracranial metastases is less than 3cm measured by enhanced brain MRI(2-3mm)
• Prior endocrine therapy were allowed
• Anti-Her2 targeted treatment were allowed
• Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):

Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN)

• Time interval from chemotherapy was more than 2 weeks, endocrine therapy and anti-Her2 targeted treatment are allowed to be used concurrently with FSRT
• Signed the informed consent form prior to patient entry

Exclusion Criteria:

• Leptomeningeal or hemorrhagic metastases
• Uncontrolled epilepsy
• Severe complication: cardiovascular disease, end-stage renal disease, severe hepatic disease, infection etc.
• Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
• Inability to complete enhanced MRI
• Patients who are difficult or unable to be followed-up
• Not suitable for inclusion for specific reasons judged by sponsor
• Patients who are receiving cytotoxic drug concomitantly
• Have received prior radiotherapy for brain metastasis