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Sponsored by: |
Eisai Medical Research Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00337103 |
This is an open-label, randomized, two-parallel arm study comparing E7389 with capecitabine. Patients will be randomized to receive either E7389 or capecitabine on a one-to-one ratio.
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: E7389 Drug: Capecitabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes and Refractory to the Most Recent Chemotherapy |
Estimated Enrollment: | 1100 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: E7389
E7389 1.4 mg/m^2 IV infusion given over 2-5 minutes on Days 1 and 8 every 21 days;
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2: Active Comparator |
Drug: Capecitabine
Capecitabine 2.5g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with locally advanced or metastatic disease who have received up to three prior chemotherapy regimens, and no more than two prior regimens for advanced disease. The regimes must have included an anthracycline and a taxane.
Exclusion Criteria:
Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study.
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Objectives:
The primary objective of this study is to compare the efficacy of E7389 versus capecitabine monotherapy, in terms of Overall Survival and Progression-Free Survival in patients with locally advanced or metastatic breast cancer.
Secondary objectives are to assess:
Contact: Eisai Eisai Medical Services | 1-888-422-4743 |
Study Director: | Corina Akerele, M.D. | Eisai Medical Research Inc. |
Responsible Party: | Eisai Medical Research Inc. ( Corina Akerele, MD ) |
Study ID Numbers: | E7389-G000-301 |
Study First Received: | June 13, 2006 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00337103 |
Health Authority: | United States: Food and Drug Administration |
Capecitabine Skin Diseases Breast Neoplasms Taxane Breast Diseases |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |