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| Tracking Information | |||||
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| First Received Date ICMJE | May 7, 2004 | ||||
| Last Updated Date | November 16, 2009 | ||||
| Start Date ICMJE | November 2003 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Overall Survival (OS) [ Time Frame: from date of randomization until death ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Overall Survival from Date of Randomization to Death | ||||
| Change History | Complete list of historical versions of study NCT00082433 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Time To Progression; Response Rate and Duration of Response in patients with Measureable disease; Quality of Life | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1221 | ||||
| Completion Date | March 2008 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Korea, Republic of, Netherlands, Portugal, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00082433 | ||||
| Responsible Party | Study Director, Bristol-Myers Squibb | ||||
| Study ID Numbers ICMJE | CA163-048 | ||||
| Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Bristol-Myers Squibb | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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