Spots Global Cancer Trial Database for Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer
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Trial Identification
Brief Title: Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer
Official Title: Phase II Trial of Metronomic Eribulin (Halaven) in Pretreated Metastatic Breast Cancer (MBC)
Study ID: NCT01908101
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
MultiCare Tacoma General Hospital, Tacoma, Washington, United States
Wenatchee Valley Hospital and Clinics, Wenatchee, Washington, United States
Contact Details
Name: Hannah Linden
Affiliation: Fred Hutch/University of Washington Cancer Consortium
Role: PRINCIPAL_INVESTIGATOR
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