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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00080301 |
The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.
Condition | Intervention | Phase |
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Breast Cancer Metastases |
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 Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant |
Enrollment: | 752 |
Study Start Date: | September 2003 |
Study Completion Date: | March 2008 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: Ixabepilone + Capecitabine
Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity |
B: Active Comparator |
Drug: Capecitabine
Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
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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: | CA163-046 |
Study First Received: | March 26, 2004 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00080301 |
Health Authority: | United States: Food and Drug Administration |
Metastatic Breast Cancer |
Capecitabine Skin Diseases Fluorouracil Epothilones |
Neoplasm Metastasis Breast Neoplasms Taxane Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Tubulin Modulators |