This is a pilot study, the principal investigator plans to enroll 14 patients. If 2 or more responses are documented, the principal investigator will consider to start a new phase II study. If there is less than 2 responses in the 14 patients, it is unlikely that Eribulin will produce 15% or more response rate in patients with active brain metastases, thus indicating no need to study further. Based on Poisson distribution, there is 38% probability of observing 1 or 0 response even if the underlying response is 15%. There is no null hypothesis, hence no p-value of significance.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
1.4mg/m2/dose on days 1 and 8 of a 21-day treatment cycle.
Tan Tock Seng Hospital
Singapore, Singapore
RECRUITINGChang-Gung Memorial Hospital
Taoyuan, Taiwan
RECRUITINGObjective Tumor Response Rate in Brain as measured using RANO-BM criteria
To evaluate the tumor response rate in the the brain every 6 weeks for the first 4 cycles of Eribulin, then every 9 weeks for the subsequent cycles.
Time frame: Every 6 weeks for the first 4 cycles, then every 9 weeks for the subsequent cycles
Extracranial objective tumor response rate as measured using RECIST 1.1 criteria
To evaluate the extracranial objective tumor response by doing CT Scan/MRI every 6 weeks for the first 4 cycles of Eribulin, then every 9 weeks for the subsequent cycles.
Time frame: Every 6 weeks for the first 4 cycles, then every 9 weeks for the subsequent cycles
Duration of Response in Brain
To assess the duration of response by doing an MRI Brain every 6 weeks for the first 4 cycles of Eribulin, then every 9 weeks for the subsequent cycles. .
Time frame: Every 6 weeks for the first 4 cycles, then every 9 weeks for the subsequent cycles
Assessment of toxicities such as neuropathy, hematological and hepatological toxicities
To assess the toxicities of patients receiving Eribulin. The assessment will include the physical examinations, weight and vital signs monitoring, 12 lead ECGs, 2D Echo, collection of Adverse Events (AE) as well as Laboratory assessments including hematology and chemistry. Toxicity will be assessed based on the medical review of adverse events, reports and laboratory tests throughout the study.
Time frame: 3 years
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