Clinical trial NCT04061408: FSRT in Breast Cancer Patients With Brain Metastases
Official title: A Phase II Pilot Study of Fractionated Stereotactic Radiotherapy(FSRT) in Breast Cancer Patients With 1 to 10 Brain Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Brain Metastases
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, many studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. Also, several studies had demonstrated that 5-10 lesions had similar overall survival by using whole brain radiotherapy or stereotactic radiotherapy. Fractionated stereotactic radiotherapy(FSRT) is increasingly administered in the brain metastatic patients and retrospective studies had shown that FSRT had better local control and lower brain radiation necrosis than single fraction stereotactic radiation. Therefore, In this study, we explore to treat 1-10 brain metastasis lesion in breast cancer patients with FSRT.

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 volume.

Eligibility criteria: 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

Primary outcomes:
measure: intracranial local tumor control rate
timeFrame: 2 years
Secondary outcomes:
measure: Intracranial distant metastasis rate
timeFrame: 2 years
measure: Intracranial Progression-Free Survival (PFS)
timeFrame: 2 years
measure: overall survival(OS)
timeFrame: 3 years
measure: Adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: