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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00082433 |
The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.
Condition | Intervention | Phase |
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Cancer Breast Cancer |
Drug: Ixabepilone + Capecitabine Drug: Capecitabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane |
Enrollment: | 1221 |
Study Start Date: | November 2003 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: Ixabepilone + Capecitabine
Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle
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B: Active Comparator |
Drug: Capecitabine
Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA163-048 |
Study First Received: | May 7, 2004 |
Results First Received: | May 1, 2009 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00082433 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Capecitabine Immunologic Factors Skin Diseases Fluorouracil Epothilones |
Tubulin Modulators Breast Neoplasms Antimitotic Agents Immunosuppressive Agents Taxane Breast Diseases |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Immunologic Factors Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Epothilones Mitosis Modulators Physiological Effects of Drugs |
Breast Neoplasms Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Fluorouracil Tubulin Modulators Breast Diseases |