Conditions: Breast Cancer
Keywords: Breast Cancer Oncology
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 104
Healthy volunteers: no

Brief summary:
The purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) grading.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Eribulin Mesylate intervention 2: Ixabepilone
Intervention descriptions: intervention 1: E7389 (eribulin mesylate) given at a dose of 1.4 mg/m\^2 as a 2 to 5 minute intravenous (IV) bolus on Days 1 and 8 of a 21-day cycle.

The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment. intervention 2: Ixabepilone given at a starting dose of 32 or 40 mg/m\^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle.

The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.

Protocol document: