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E7389 Versus Treatment of Physician's Choice in Patients With Locally Recurrent or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Eisai Limited
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00388726
First received: October 13, 2006
Last updated: July 25, 2014
Last verified: July 2014
Results First Received: December 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: E7389
Drug: Physician's Choice

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was recruited at 135 centers in 19 countries during the period of Nov 2006 to May 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Eribulin Mesylate 1.4 mg/kg^2 Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
Treatment of Physician's Choice Treatment of Physician's Choice

Participant Flow:   Overall Study
    Eribulin Mesylate 1.4 mg/kg^2   Treatment of Physician's Choice
STARTED   508   254 
COMPLETED   24   10 
NOT COMPLETED   484   244 
Adverse Event                50                24 
Progressive Disease                336                153 
Clinical Progression                61                36 
Withdrawal by Subject                10                7 
Administrative                6                9 
Physician Decision                18                13 
Death                3                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Eribulin Mesylate 1.4 mg/kg^2 Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
Treatment of Physician's Choice Treatment of Physician's Choice
Total Total of all reporting groups

Baseline Measures
   Eribulin Mesylate 1.4 mg/kg^2   Treatment of Physician's Choice   Total 
Overall Participants Analyzed 
[Units: Participants]
 508   254   762 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.8  (10.34)   55.9  (10.43)   55.2  (10.37) 
Gender 
[Units: Participants]
     
Female   508   254   762 
Male   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   3   2   5 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   20   14   34 
White   470   233   703 
More than one race   0   0   0 
Unknown or Not Reported   15   5   20 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: From date of randomization until death from any cause ]

2.  Secondary:   Progression-Free Survival.   [ Time Frame: Until disease progression or death. ]

3.  Secondary:   Best Overall Response   [ Time Frame: Until Day 30 or every 3 months during Follow-up period for patients who complete study without PD. ]

4.  Secondary:   Duration of Response.   [ Time Frame: From first documented CR or PR until disease progression or death. ]

5.  Secondary:   Safety Parameters: Adverse Events (AEs), Laboratory Parameters, Concomitant Medication, Electrocardiograms (ECGs), and Study Drug Exposure.   [ Time Frame: AEs and conmeds – until study termination; lab tests – Day 1 and weekly until study termination; ECGs - Day 1 and at study termination. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Peter Tarassoff
Organization: Eisai
phone: 888-422-4743


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00388726     History of Changes
Other Study ID Numbers: E7389-G000-305
2006-001949-34 ( EudraCT Number )
Study First Received: October 13, 2006
Results First Received: December 22, 2011
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency