Working… Menu

Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01908101
Recruitment Status : Completed
First Posted : July 25, 2013
Results First Posted : July 23, 2020
Last Update Posted : July 23, 2020
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Metronomic Eribulin (Halaven) in Pretreated Metastatic Breast Cancer (MBC)
Actual Study Start Date : January 8, 2014
Actual Primary Completion Date : May 4, 2019
Actual Study Completion Date : May 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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:
  • B1939 Mesylate
  • E7389
  • ER-086526
  • Halaven
  • Halichondrin B Analog

Other: Laboratory Biomarker Analysis
Correlative studies

Primary Outcome Measures :
  1. PFS [ Time Frame: From study enrollment until the earliest date of disease progression or death, assessed up to 1 year ]
    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 must have baseline imaging within 30 days prior to the start of therapy and satisfy one of the following:

    • 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
    • Non-measurable disease by RECIST 1.1 criteria (includes bone only disease and lesions < 10 mm or lymph nodes < 15 mm in short axis) with rising serum CA15-3 or CA 27.29 or CEA documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration. The second CA 15-3 or CA 27.29 value must have at least a 20% increase over the first and for CA 15-3 or CA27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL
  • 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
  • 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 systemic 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01908101

Layout table for location information
United States, Alaska
Katmai Oncology Group
Anchorage, Alaska, United States, 99508
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States, 85724
United States, Montana
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
United States, Oregon
Bend Memorial Clinic
Bend, Oregon, United States, 97701
United States, Washington
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
Olympic Medical Center
Port Angeles, Washington, United States, 98362
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Group Health Cooperative-Seattle
Seattle, Washington, United States, 98112
MultiCare Tacoma General Hospital
Tacoma, Washington, United States, 98405
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States, 98801
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Hannah Linden Fred Hutch/University of Washington Cancer Consortium
  Study Documents (Full-Text)

Documents provided by University of Washington:
Layout table for additonal information
Responsible Party: University of Washington Identifier: NCT01908101    
Other Study ID Numbers: 8093
NCI-2013-01326 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
8093 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2013    Key Record Dates
Results First Posted: July 23, 2020
Last Update Posted: July 23, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Halichondrin B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents