Status:
COMPLETED
Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Lead Sponsor:
R-Pharm
Conditions:
Cancer
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
1221 Patients enrolled
Trial Details
Trial ID
NCT00082433
Start Date
November 1 2003
End Date
March 1 2008
Last Update
November 2 2020
Active Locations (186)
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1
Local Institution
Tucson, Arizona, United States
2
Local Institution
Beverly Hills, California, United States
3
Local Institution
Corona, California, United States
4
Local Institution
Hartford, Connecticut, United States