Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by University of Washington
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington Identifier:
First received: July 19, 2013
Last updated: November 12, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Recurrent Breast Carcinoma
Stage IV Breast Cancer
Drug: Eribulin Mesylate
Other: Laboratory Biomarker Analysis
Phase 2

Study Type: Interventional
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)

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Incidence of adverse events, graded according to 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.

Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Given IV
Other Names:
  • E7389
  • ER-086526
  • Halaven
  • Halichondrin B Analog
Other: Laboratory Biomarker Analysis
Correlative studies

Detailed Description:


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 for 1 year.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ability to provide written informed consent
  • Prior exposure to taxane in the adjuvant, neoadjuvant or metastatic setting
  • At least one prior regimen of chemotherapy in the setting of metastatic breast cancer; no upper limit on the number of prior endocrine regimens for metastatic breast cancer, however no more than 6 chemotherapeutic regimens may have been given in the metastatic setting
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Patients with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

    • At least one non-lymph node lesion of >= 1.0 cm or lymph node >= 1.5 cm in short axis by computerized tomography (CT) scan (CT scan thickness no greater than 5 mm which is serially measurable according to RECIST 1.1 using either computerized tomography (CT) or magnetic resonance imaging (MRI)
    • Lesions that have had radiotherapy must show evidence of progressive disease (PD) based on RECIST 1.1 to be deemed a target lesion
  • Absolute neutrophil count >= 1,500/mm^3
  • Hemoglobin >= 10 g/dL
  • Platelets >= 100,000/mm^3
  • Creatinine =< 1.5 x upper limit of normal (ULN)
  • Total bilirubin =< 1.5 x ULN
  • Alkaline phosphatase =< 3.0 x ULN; up to 5 x ULN is acceptable if due to bone metastases in the absence of liver metastases
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x institutional upper limit of normal, unless due to liver metastases (=< 5 x ULN)
  • Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation
  • Life expectancy of > 12 weeks

Exclusion Criteria:

  • Prior treatment with eribulin (eribulin mesylate)
  • Plan to administer any other systemic antitumor including endocrine therapy except for following standard of care treatment:

    • Trastuzumab at standard dosing human epidermal growth factor receptor 2 (HER2) positive tumors
    • Denosumab or bisphosphonates to treat metastatic bone disease
  • Plan to administer concurrent radiation therapy now or for progressive symptoms during treatment
  • Patients with known central nervous system (CNS) metastases must have stable disease off steroids after treatment with surgery or radiation therapy
  • Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
  • Patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate (creatinine clearance [CrCl] 30-50 mL/min) renal impairment
  • Radiotherapy within 14 days of study treatment
  • Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery
  • Treatment with any chemotherapy or investigational agents within 3 weeks of the start of study treatment; endocrine treatment must be stopped prior to initiating study treatment; subjects must have recovered from toxicities of prior therapy
  • Patients with peripheral neuropathy > grade 2 regardless of etiology
  • Significant cardiovascular impairment: congestive heart failure > class II according to the New York Heart Association (NYHA), unstable angina or myocardial infarction within 6 months of enrollment, or serious cardiac arrhythmia (> grade 2)
  • Concomitant severe or uncontrolled medical disease
  • Significant psychiatric or neurologic disorder which would compromise participation in the study
  • Pregnant or breast-feeding females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01908101

United States, Alaska
Katmai Oncology Group Recruiting
Anchorage, Alaska, United States, 99508
Contact: Jeanne E. Anderson    907-562-0321   
Principal Investigator: Jeanne E. Anderson         
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Roy Davis    907-212-3629      
Principal Investigator: Jeanne E. Anderson         
United States, Arizona
The University of Arizona Medical Center-University Campus Recruiting
Tucson, Arizona, United States, 85724
Contact: Pavani Chalasani    520-626-0191   
Principal Investigator: Pavani Chalasani         
United States, Montana
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
Contact: Spencer Green    406-585-5070      
Principal Investigator: Jack O. Hensold         
United States, Oregon
Bend Memorial Clinic Recruiting
Bend, Oregon, United States, 97701
Contact: Karla Lichter    541-318-3137      
Principal Investigator: William G. Schmidt         
United States, Washington
Kadlec Clinic Hematology and Oncology Recruiting
Kennewick, Washington, United States, 99336
Contact: Heather Johansen    509-783-4637 ext 1   
Principal Investigator: Thomas A. Rado         
Skagit Valley Hospital Recruiting
Mount Vernon, Washington, United States, 98274
Contact: Richard J. Abbott    360-428-8450      
Principal Investigator: Kiarash Kojouri         
Olympic Medical Center Recruiting
Port Angeles, Washington, United States, 98362
Contact: Eric Lewis    360-417-7705   
Principal Investigator: Thomas D. Kummet         
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         
Group Health Cooperative-Seattle Recruiting
Seattle, Washington, United States, 98112
Contact: Josephine Faust    206-225-7893   
Principal Investigator: Eric Y. Chen         
Multicare Health System Recruiting
Tacoma, Washington, United States, 98415
Contact: Kathy D. Smith    253-403-1030   
Principal Investigator: Troy W. Wadsworth         
Wenatchee Valley Hospital and Clinics Recruiting
Wenatchee, Washington, United States, 98801
Contact: Jay Johnson    509-663-8711      
Principal Investigator: Lindsay C. Overton         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Hannah Linden Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington Identifier: NCT01908101     History of Changes
Other Study ID Numbers: 8093, NCI-2013-01326, 8093, P30CA015704
Study First Received: July 19, 2013
Last Updated: November 12, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on November 25, 2015