Conditions: Cancer Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1221
Healthy volunteers: no

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 metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ixabepilone + Capecitabine intervention 2: Capecitabine
Intervention descriptions: intervention 1: Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle intervention 2: Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle

Protocol document: