This phase II trial studies how well eribulin mesylate works in treating patients with previously treated breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
PRIMARY OBJECTIVES: I. Progression free survival (PFS). SECONDARY OBJECTIVES: I. Frequency of alopecia with absence or decrease to \< 50%. II. Incidence of grade 3 and 4 neutropenia of \< 30%. III. Incidence of sensory neuropathy (all grades) to \< 25%. TERTIARY OBJECTIVES: I. Assess the role of circulating endothelial cell precursors (CEPs) and apoptotic circulating endothelial cells (CECs), in predicting early response to treatment. OUTLINE: Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Given IV
Correlative studies
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States
PFS
Kaplan-Meier survival curves will be used to describe PFS, overall and stratified by number of prior metastatic treatment regimens. A 95% confidence interval for the median PFS will be calculated using the method of Brookmeyer and Crowley.
Time frame: From study enrollment until the earliest date of disease progression or death, assessed up to 1 year
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Bozeman Deaconess Hospital
Bozeman, Montana, United States
Bend Memorial Clinic
Bend, Oregon, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Skagit Valley Hospital
Mount Vernon, Washington, United States
Olympic Medical Center
Port Angeles, Washington, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Group Health Cooperative-Seattle
Seattle, Washington, United States
...and 2 more locations