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Epothilone (ixabepilone) plus Capecitabine versus Capecitabine Alone in Patients with Advanced Breast Cancer



Epothilone (ixabepilone) plus Capecitabine versus Capecitabine Alone in Patients with Advanced Breast Cancer

For Condition: Cancer,Breast Cancer
Status: Recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: - Patients must have received prior treatment which included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel). - Patients must have received no more than two prior chemotherapy regimens. Patients who have not received treatment for metastatic disease must have relapsed within one year. - Patients may not have any history of brain and/or leptomeningeal metastases. - Patients may not have Grade 2 or worse neuropathy at the time of study entry. - Patients may not have had prior treatment with any epothilones and/or capecitabine (i.e. Xeloda)
Total Enrollment: 

Location and Contact Information:

Various locations within the US and Canada *Recruiting*
Call for information,  New Jersey, 
United States
Recruiting Bristol-Myers  Call Center 1-866-892-1BMS


Additional Information:
Study ID Numbers:
  CA163-048; 
Study Start Date: May 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082433

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