Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Eisai Limited
Information provided by (Responsible Party):
Eisai Inc. Identifier:
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
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
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  
Number of Participants  
[units: participants]
  508     254     762  
[units: years]
Mean ± Standard Deviation
  54.8  ± 10.34     55.9  ± 10.43     55.2  ± 10.37  
[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

No publications provided by Eisai Inc.

Publications automatically indexed to this study:

Responsible Party: Eisai Inc. Identifier: NCT00388726     History of Changes
Other Study ID Numbers: E7389-G000-305, 2006-001949-34
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