At a glance
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A Phase II, Multicenter, Randomized, Open-Label Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Eribulin Mesylate and Ixabepilone for Breast Cancer. Completed, enrolled 104 participants across 50 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.