About HERA

The main objective of the HERA trial was to compare the clinical benefits and the effects of giving one and two years of the anti-HER2 therapy trastuzumab (Herceptin®) in addition to standard treatment versus standard treatment alone for patients with HER2-positive early breast cancer.

HER2-positive breast cancer is a particularly aggressive form of the disease that previously meant poor survival rates. In Human Epidermal Growth Factor Receptor (HER) 2-positive breast cancer, increased quantities of a protein known as HER2 that promotes cell growth are present on the surface of the tumour cells. This represents approximately 15-20% of patients with breast cancer. 

A total of 5,102 patients were enrolled in the trial between 2001 and 2005 and assigned to one of the following three groups: observation (standard of care); one year of trastuzumab; two years of trastuzumab.

The study’s main results – published in 2005 in the New England Journal of Medicine – indicated that one year of treatment with trastuzumab had a significant and sustained benefit in preventing cancer recurrence and improving overall survival among patients with HER2-positive breast cancer. Two years of the drug was not found to have a significant benefit in comparison to one year of treatment.

The trial conclusions helped accelerate the approval of the drug trastuzumab, which has cut relapse rates by 50% and is now the standard treatment for this type of breast cancer.

The HERA trial enrolled 5,102 women from 480 hospitals across 39 countries in just four years – in itself a remarkable achievement. Involving 27 academic cancer research groups part of the BIG network, it is an example of a successful practice-changing clinical trial since it contributed to a new standard of treatment for women with HER2-positive, early breast cancer, a highly aggressive form of the disease.