E7389 Versus Treatment of Physician's Choice in Patients With Locally Recurrent or Metastatic Breast Cancer
The purpose of this study is to compare Overall Survival (OS), Progression Free Survival (PFS), objective tumor response rate, duration of response, and safety in patients treated with E7389 versus the Treatment of Physician's Choice (TPC) in patients with locally recurrent or metastatic breast cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The "EMBRACE" Trial: Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389. A Phase III Open-Label, Randomized, Parallel, Two-arm, Multi-center Study of E7389 Versus "Treatment of Physician's Choice" in Patients With Locally Recurrent, Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane|
- Overall Survival [ Time Frame: From date of randomization until death from any cause ] [ Designated as safety issue: No ]Defined as the time from the date of randomization until the date of death from any cause.
- Progression-Free Survival. [ Time Frame: Until disease progression or death. ] [ Designated as safety issue: No ]Measured using Response Evaluation Criteria in Solid Tumors (RECIST) and defined as the time from the date of randomization until progressive disease or death from any cause in the absence of of progressive disease.
- Best Overall Response [ Time Frame: Until Day 30 or every 3 months during Follow-up period for patients who complete study without PD. ] [ Designated as safety issue: No ]Measured by RECIST criteria and 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 CR or PR until disease progression or death. ] [ Designated as safety issue: No ]As measured by RECIST criteria and defined as the time from the first documented CR or PR until disease progression or death from any cause.
- 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. ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2006|
|Study Completion Date:||March 2010|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
|Active Comparator: 2||
Drug: Physician's Choice
Treatment of the Physician's Choice defined as any single agent chemotherapy, hormonal treatment or biological therapy approved for the treatment of cancer; or palliative treatment or radiotherapy, administered according to local practice, if applicable.
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|Study Director:||Jantien Wanders, M.D.||Eisai Limited|