Eisai Announces Preliminary Results of Phase III Study of Halaven® (Eribulin) in Locally Advanced or Metastatic Breast Cancer PR Newswire HATFIELD, England, July 10, 2012 HATFIELD, England, July 10, 2012 /PRNewswire/ -- Eisai Europe Limited today announces preliminary results from a recently ®completed Phase III study (Study 301) comparing Halaven (eribulin) and ®Xeloda (capecitabine). The study enrolled women with locally advanced or metastatic breast cancer in an earlier line of treatment than eribulin is currently licensed for. Preliminary results showed that the trial did not meet the pre-specified criteria for either of the co-primary endpoints of overall survival (OS) and progression-free survival (PFS). However, the study did show a trend towards improved OS for patients who received eribulin compared with capecitabine, but the improvement was not statistically significant. No difference was seen in PFS. Furthermore, safety was consistent with the known profile of eribulin. Eisai plans to conduct a detailed analysis of the clinical trial data including the secondary endpoints and subgroups pre-specified in the study protocol and will work with the regulatory authorities towards potential regulatory filings. Further study results will be submitted for presentation at forthcoming international medical meetings. "With over 1,100 women with advanced breast cancer studied, this is one of the largest studies ever conducted in this patient population.