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Sponsors and Collaborators: |
Eisai Medical Research Inc. Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00388726 |
The primary objective of this study is to compare Overall Survival (OS) in patients treated with E7389 versus the Treatment of Physician's Choice (TPC) in patients with locally recurrent or metastatic breast cancer.
Secondary objectives are to assess:
Condition | Intervention | Phase |
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Breast Cancer |
Drug: E7389 Drug: Physician's Choice |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 630 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: E7389
1.4 mg/m2 IV infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
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2: Active Comparator |
Drug: Physician's Choice
Any treatment of the physician's choice used in treating cancer.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Female patients with histologically or cytologically confirmed carcinoma of the breast.
Every effort should be made to make paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.
Patients with locally recurrent or metastatic disease who have received at least two (and not more than five) prior chemotherapeutic regimens for breast cancer, at least two of which were administered for treatment of locally recurrent and/or metastatic disease.
Prior therapy must be documented by the following criteria prior to entry onto study:
EXCLUSION CRITERIA
Patients who have received any of the following treatments within the specified period before E7389 or TPC treatment start:
Contact: Eisai Eisai Medical Services | 1-888-422-4743 |
Study Director: | Jantien Wanders, M.D. | Eisai Limited |
Responsible Party: | Eisai Limited ( Jantien Wanders, MD, Study Director ) |
Study ID Numbers: | E7389-G000-305 |
Study First Received: | October 13, 2006 |
Last Updated: | April 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00388726 |
Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency |
Locally recurrent or metastatic breast cancer |
Skin Diseases Breast Neoplasms Taxane Breast Diseases Recurrence |
Neoplasms Neoplasms by Site |