Subjects are asked to take part in a clinical research study that tests Eribulin, a new drug. Eribulin is an investigational (experimental) anti-cancer agent that has not been approved by the Food and Drug Administration (FDA) for use in patients with brain metastases. Eribulin is FDA approved for use in patients with metastatic breast cancer but the effect it may or may not have on brain metastases has not been studied.
Primary Objectives: To determine the 3-month central nervous system (CNS)-progression free survival (PFS) for patients with metastatic breast cancer with brain metastases treated with eribulin mesylate. Secondary Objective(s): 1\. Estimate CNS complete and partial response rates (CR and PR) and duration of CNS response in this patient population. 2 Evaluate toxicity in patients with breast cancer with brain metastases treated with eribulin mesylate. 3 Estimate clinical benefit rate (CBR) at 3 months in breast cancer patients with brain metastases treated with eribulin mesylate. (CBR is the sum of CR, PR and stable disease at 3 months). 4 To estimate systemic disease (extra cranial) response rate and duration of systemic response in this patient population. 5 Overall survival in this patient population. Design: This is a phase II study that will require patients to evaluate the primary objective (CNS PFS at 3 months). Study patients will have a baseline brain MRI and a second MRI at 12 weeks to evaluate disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Zofran at 8mg orally. Given at the discretion of the treating physician
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)
The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
Time frame: At 12 weeks
Objective Response Rate (RR)
The study team will calculate the percent of participants with complete and partial response. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
Time frame: up to 2 years from start of treatment
Median Duration of CNS Response
The study team will calculate the duration of CNS response. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
Time frame: up to 2 years from start of treatment
Number of Patients Treated With Eribulin Who Experienced Serious Adverse Events
The study team will evaluate rates (and 95% CI) of toxicity in patients treated with eribulin.
Time frame: up to 2 years from start of treatment
Number of Patients With CBR
The study team will sum the proportion of the patients with complete response, partial response and stable disease at 12 weeks (CBR)
Time frame: At 12 weeks
Systemic Disease Response Rate
The study team will estimate systemic disease response rate (and 95% CI) and perform a Kaplan-Meier analysis for systemic response in this patient population
Time frame: up to 2 years from start of treatment
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decadron at 8mg orally. Given at the discretion of the treating physician
Median Overall Survival (OS)
The study team will generate a Kaplan-Meier curve of OS.
Time frame: up to 2 years from start of treatment