Updated on 10 July 2012
The study included patients with zero to two previous chemotherapies for advanced disease. Patients were randomized at a ratio of 1:1 to receive treatment with Halaven or capecitabine in accordance with their HER2/neu status and geographic region.
Patients received either Halaven 1.4mg/m2 (administered intravenously over two to five minutes on days one and eight, every 21 days) or capecitabine 2.5g/m2/day (administered orally twice daily in two equal doses on days one-to-14, every 21 days). Adverse events observed in the trial were consistent with the known safety profile of Halaven found in the full prescribing information.