Since the last data sweep was completed in November 2006, the monitoring board advised the company to conduct a further data sweep to bring the survival data current prior to performing the third interim analysis. This data sweep is ongoing and the company expects this work to be completed and to have a formal recommendation in February 2007.
The phase III trial compares the survival of patients treated with tesmilifene combined with epirubicin/cyclophosphamide to epirubicin/cyclophosphamide alone in women with rapidly progressing breast cancer. The trial, which completed enrollment of patients in September 2005, is the subject of a special protocol assessment and a fast track designation for advanced breast cancer by the FDA.
The trial is being conducted according to a sequential design that permits a number of planned interim analyses and the trial will continue until one of two specific statistical conditions is satisfied.