A Phase II Study of E7389 in Patients With Breast Cancer, Previously Treated With Anthracycline, Taxane and Capecitabine
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|ClinicalTrials.gov Identifier: NCT00246090|
Recruitment Status : Completed
First Posted : October 31, 2005
Results First Posted : May 15, 2012
Last Update Posted : July 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: E7389||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||298 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Open Label Single-Arm Study of E7389 in Patients With Locally Advanced or Metastatic Breast Cancer, Previously Treated With Anthracycline, Taxane, and Capecitabine Therapy, Refractory to the Last Prior Therapy for Their Disease|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
- Objective Response Rate [ Time Frame: Every two cycles ]Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
- Duration of Response [ Time Frame: From first documented complete or partial response until disease progression or death ]Complete response (CR) is defined as the disappearance of all lesions. Partial response (PR) is defined as 30% decrease in lesion diameter.
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 ClinicalTrials.gov identifier (NCT number): NCT00246090
Show 65 Study Locations
|Study Director:||Dale Shuster, Ph.D.||Eisai Inc.|