E7389 Versus Treatment of Physician's Choice in Patients With Locally Recurrent or Metastatic Breast Cancer
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| ClinicalTrials.gov Identifier: NCT00388726 |
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Recruitment Status :
Completed
First Posted : October 17, 2006
Results First Posted : January 30, 2012
Last Update Posted : January 7, 2020
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Sponsor:
Eisai Inc.
Collaborator:
Eisai Limited
Information provided by (Responsible Party):
Eisai Inc.
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Breast Cancer |
| Interventions |
Drug: E7389 Drug: Physician's Choice |
| Enrollment | 762 |
Participant Flow
| Recruitment Details | This study was recruited at 135 centers in 19 countries during the period of Nov 2006 to May 2009. |
| Pre-assignment Details |
| Arm/Group Title | Eribulin Mesylate 1.4 mg/kg^2 | Treatment of Physician's Choice |
|---|---|---|
 Arm/Group Description |
Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8 | Treatment of Physician's Choice |
| Period Title: Overall Study | ||
| Started | 508 | 254 |
| Completed | 24 | 10 |
| Not Completed | 484 | 244 |
| Reason Not Completed | ||
| 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
| Arm/Group Title | Eribulin Mesylate 1.4 mg/kg^2 | Treatment of Physician's Choice | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8 | Treatment of Physician's Choice | Total of all reporting groups | |
| Overall Number of Baseline Participants | 508 | 254 | 762 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 508 participants | 254 participants | 762 participants | |
| 54.8 (10.34) | 55.9 (10.43) | 55.2 (10.37) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 508 participants | 254 participants | 762 participants | |
| Female |
508 100.0%
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254 100.0%
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762 100.0%
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| Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 508 participants | 254 participants | 762 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
3 0.6%
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2 0.8%
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5 0.7%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
20 3.9%
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14 5.5%
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34 4.5%
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| White |
470 92.5%
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233 91.7%
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703 92.3%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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|
| Unknown or Not Reported |
15 3.0%
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5 2.0%
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20 2.6%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Eisai Medical Information |
| Organization: | Eisai Inc. |
| Phone: | 1-888-274-2378 |
| EMail: | esi_oncmedinfo@eisai.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00388726 |
| Other Study ID Numbers: |
E7389-G000-305 2006-001949-34 ( EudraCT Number ) |
| First Submitted: | October 13, 2006 |
| First Posted: | October 17, 2006 |
| Results First Submitted: | December 22, 2011 |
| Results First Posted: | January 30, 2012 |
| Last Update Posted: | January 7, 2020 |