NCT01908101

Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer

Phase II Trial of Metronomic Eribulin (Halaven) in Pretreated Metastatic Breast Cancer (MBC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Breast Carcinoma
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	Eribulin Mesylate	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2014-01-08
• Primary completion: 2019-05-04
• Completion: 2019-05-04
• First posted: 2013-07-25
• Last updated: 2020-07-23
• Results posted: 2020-07-23

Locations

12 sites across 1 country: United States