HERA
FSS is collaborating with the Breast International Group
(BIG)
and Roche
Pharmaceuticals on the HERA
trial, an adjuvant trial comparing observation vs one year
of Herceptin® vs two years of Herceptin® in women with early
stage HER2 positive breast cancer. FSS has worked with BIG
and the Coordinating Group BrEAST on many aspects of trial management for HERA, on data quality
control and on the statistical analysis of the data. The
first results of the study were published in the New
England Journal of Medicine in October 2005. Results at 2 years median follow up were published in the Lancet (Smith, Ian et al). The first cardiac manuscript was published in the Journal of Clinical Oncology in 2007 (Suter, Thomas et al). Further publications are currently in preparation.
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