Recruiting 5,102 women from 480 sites across 39 countries in just over four years – in itself a remarkable achievement – HERA contributed to a new standard of treatment for women with HER2-positive, early breast cancer, a highly aggressive form of the disease.
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The study’s main results, published in 2005 and in 2017, indicated that one year of treatment with trastuzumab had a significant and sustained benefit in preventing cancer recurrence and improving overall survival among this group of patients.
Coordinated by BIG, the Institut Jules Bordet – Clinical Trials Support Unit, and Frontier Science Scotland in collaboration with Roche, HERA involved the participation of 27 BIG collaborative groups and helped accelerate the approval of trastuzumab, becoming a standard treatment for HER2-positive breast cancer.
The final analysis of HERA was published in The Lancet in April 2017 and showed that both the risk of recurrence and of death were reduced by 25% over time. As noted in the paper, to our knowledge, this 11-year follow-up provides the longest survival data of any trial that assessed the addition of anti-HER2 therapy to standard treatment for HER2-positive early breast cancer.