Breast cancer patients with 1-10 brain metastasis will be treated with FSRT for brain metastasis. 3 to 5 fractions and 8Gy per fraction will be used for these patients based on the lesion number and volume.
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | FSRT in Breast Cancer Patients With Brain Metastases
