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Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT01908101
Recruitment Status : Completed
First Posted : July 25, 2013
Results First Posted : July 23, 2020
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Breast Carcinoma
Stage IV Breast Cancer
Interventions Drug: Eribulin Mesylate
Other: Laboratory Biomarker Analysis
Enrollment 86
Recruitment Details  
Pre-assignment Details 86 patients signed the study informed consent, but only 68 patients started the Eribulin treatment. Out of those 68 patients only 59 of them were evaluable.
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description

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.

Eribulin Mesylate: Given IV

Laboratory Biomarker Analysis: Correlative studies

Period Title: Overall Study
Started 68
Completed 59
Not Completed 9
Reason Not Completed
Physician Decision             1
Withdrawal by Subject             1
Incorrect Diagnosis             2
Incorrect Starting Dose             1
Did not complete the first cycle             4
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description

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.

Eribulin Mesylate: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Baseline Participants 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
<=18 years
0
   0.0%
Between 18 and 65 years
45
  76.3%
>=65 years
14
  23.7%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 59 participants
52
(18 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
59
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Hispanic or Latino
6
  10.2%
Not Hispanic or Latino
52
  88.1%
Unknown or Not Reported
1
   1.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
American Indian or Alaska Native
2
   3.4%
Asian
4
   6.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   6.8%
White
49
  83.1%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 59 participants
59
 100.0%
1.Primary Outcome
Title PFS
Hide Description 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.
Time Frame From study enrollment until the earliest date of disease progression or death, assessed up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with metastatic breast cancer (MBC) whose disease has progressed following at least one prior regimen of chemotherapy in the setting of metastatic breast cancer
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description:

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.

Eribulin Mesylate: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 59
Median (95% Confidence Interval)
Unit of Measure: months
3.5
(2.6 to 4.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (Eribulin Mesylate)
Comments Progression free survival (PFS). We hypothesize that metronomic dosing of eribulin will result in a PFS of 4-6 months.
Type of Statistical Test Other
Comments comparison analysis
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
2.6 to 4.6
Estimation Comments The estimated value is 3.5 months, not years.
Time Frame Adverse events will be collected after the patient has taken the first dose of study drug. After discontinuation from treatment, patients must be followed for all existing AEs for 30 calendar days after the last dose of study drug or until another anti-cancer therapy is initiated.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description

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.

Eribulin Mesylate: Given IV

Laboratory Biomarker Analysis: Correlative studies

All-Cause Mortality
Treatment (Eribulin Mesylate)
Affected / at Risk (%)
Total   44/59 (74.58%)    
Hide Serious Adverse Events
Treatment (Eribulin Mesylate)
Affected / at Risk (%) # Events
Total   2/59 (3.39%)    
Blood and lymphatic system disorders   
Sepsis  1  1/59 (1.69%)  1
Cardiac disorders   
myocardial infarction  1  1/59 (1.69%)  1
1
Term from vocabulary, NCI CTCAE version 4
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Eribulin Mesylate)
Affected / at Risk (%) # Events
Total   23/59 (38.98%)    
Blood and lymphatic system disorders   
Lymphocyte count decreased  1  3/59 (5.08%)  3
White blood cell decreased  1  4/59 (6.78%)  4
General disorders   
Fatigue  1  3/59 (5.08%)  3
Nervous system disorders   
Neutropenia  1  13/59 (22.03%)  13
Peripheral neuropathy  1  3/59 (5.08%)  3
1
Term from vocabulary, NCI CTCAE version 4
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stefanie Parker
Organization: Seattle Cancer Care Alliance
Phone: 206-889-0917
EMail: parkers@seattlecca.org
Layout table for additonal information
Responsible Party: University of Washington
ClinicalTrials.gov 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 Submitted: July 19, 2013
First Posted: July 25, 2013
Results First Submitted: May 4, 2020
Results First Posted: July 23, 2020
Last Update Posted: July 23, 2020