Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: R-Pharm
• Treatments: Capecitabine; Epothilones

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)