Results Announced for Phase III Head-to-head Study of Halaven® (eribulin) Versus Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer

Results Announced for Phase III Head-to-head Study of Halaven® (eribulin) Versus Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer PR Newswire HATFIELD, UK, December 7, 2012 HATFIELD, UK, December 7, 2012 /PRNewswire/ -- For EU Medical Media Only Second large Phase III study for eribulin presented at San Antonio Breast Cancer Symposium ®Results from a global Phase III study (Study 301) of Halaven (eribulin) in women with metastatic breast cancer (MBC) were presented today during a plenary session at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium. For ®the first time this study compares eribulin and capecitabine (Xeloda ) in women with earlier stage locally advanced or MBC. This study, one of the largest evaluating monotherapy chemotherapy, confirms eribulin as an active drug in patients with MBC, and exploratory analyses suggest possible benefits of eribulin in specific subset of patients, [1]sufficient to warrant further studies. Eribulin is currently approved for use in later line patient populations, where the pivotal Phase III trial (EMBRACE) demonstrated a statistically significant overall survival (OS) versus current single agent treatments and showed eribulin [2]had a predictable and manageable safety profile. Study 301 had a co-primary endpoint of overall survival (OS) and progression-free survival (PFS).