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HERA trial, cutting relapse rates by 50%

Intro text: 

Recruiting 5100 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. HERA helped accelerate the approval of a drug, trastuzumab, that has cut relapse rates by 50% and is now the standard treatment for this type of breast cancer.

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.