Status:
UNKNOWN
FSRT in Breast Cancer Patients With Brain Metastases
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Brain Metastases
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Brain metastasis accounted for 10-15% of all breast cancer patients and even higher in patients with triple negative and HER2 overexpressed subtype. Stereotactic radiation is the standard option for p...
Detailed Description
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 v...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04061408
Start Date
July 1 2019
End Date
July 1 2022
Last Update
August 19 2019
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China