BIG 1-01 HERA is a randomised three-arm multi-centre comparison of one year and two years of Herceptin® versus no Herceptin® in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy.
The study results demonstrated that one year treatment with trastuzumab after adjuvant chemotherapy significantly improves disease-free survival among women with HER2-positive breast cancer (ASCO 2005/NEJM 2005), and OS (ASCO 2006).
Coordinating group: BrEAST
Study design
Start date: January 2001 Closure date: June 2005 Target nr. of patients: 4482 Final accrual: 5102 Reason for closure: reached target accrual; first analysis positive