Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer
This phase II trial studies how well eribulin mesylate works in treating patients with previously treated metastatic breast cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Drug: eribulin mesylate
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Metronomic Eribulin (Halaven) In Pretreated Metastatic Breast Cancer (MBC)|
- PFS [ Time Frame: From study enrollment until the earliest date of disease progression or death, assessed up to 1 year ] [ Designated as safety issue: No ]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.
- Prevalence of key adverse events graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]Will be calculated and 95% Wilson (score) confidence intervals reported for each.
|Study Start Date:||January 2014|
|Estimated Primary Completion Date:||February 2018 (Final data collection date for primary outcome measure)|
Experimental: Treatment (eribulin mesylate)
Patients receive eribulin mesylate 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.
Drug: eribulin mesylate
Other Names:Other: laboratory biomarker analysis
I. Progression free survival (PFS).
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%.
I. Assess the role of circulating endothelial cell precursors (CEPs) and apoptotic circulating endothelial cells (CECs), in predicting early response to treatment.
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 at 30 days and for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01908101
|United States, Arizona|
|Arizona Cancer Center - Tucson||Not yet recruiting|
|Tucson, Arizona, United States, 85724-5024|
|Contact: Pavani Chalasani 520-626-0191|
|Principal Investigator: Pavani Chalasani|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Hannah M. Linden 206-288-1234|
|Principal Investigator: Hannah M. Linden|
|Principal Investigator:||Hannah Linden||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|