Status:
COMPLETED
Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Lead Sponsor:
R-Pharm
Conditions:
Breast Cancer
Metastases
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 is better than capecitabine alone in shrinking or slowing the growth of the cancer i...
Eligibility Criteria
Inclusion
- Patients must have received either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy.
- Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
- Patients must have received a minimum cumulative dose of anthracycline or must be resistant to an anthracycline.
- Patients must be resistant to taxane therapy.
- Patients may not have any history of brain and/or leptomeningeal metastases.
- Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory).
- Patients may have not have had prior treatment with an epothilone and/or capecitabine (i.e., Xeloda)
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
752 Patients enrolled
Trial Details
Trial ID
NCT00080301
Start Date
September 1 2003
End Date
March 1 2008
Last Update
November 2 2020
Active Locations (127)
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1
Local Institution
Little Rock, Arkansas, United States
2
Local Institution
San Francisco, California, United States
3
Local Institution
Vallejo, California, United States
4
Local Institution
Denver, Colorado, United States