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The HERA trial (BIG 1-01): 11-year follow-up results published in The Lancet

Intro text: 

Further to the main trial results that were presented and published in 2005, the final analysis of the HERA study was recently published in The Lancet. Researchers reported the findings of a comparison between observation, and two durations of trastuzumab treatment at a median patient follow-up of 11 years.

Last month, The Lancet published the results of a comparison between observation and two durations of trastuzumab treatment at a median follow-up of 11 years for patients enrolled in the HERA trial.

5,099 patients* of the 5102 patients who had been randomly assigned in HERA were followed and observed for a mean duration of 11 years (1697 in the study’s observation group, 1702 in the 1-year trastuzumab goup, and 1700 in 2-year trastuzumab group).

Findings showed that the 10-year disease-free survival was 63% for the observation group, 69% for the 1-year trastuzumab group, and 69% for the 2-year trastuzumab group. 

The study investigators concluded that 1 year of adjuvant trastuzumab after chemotherapy for patients with Human Epidermal Growth Factor Receptor (HER)2-Positive early breast cancer significantly improved long-term disease-free survival, compared with observation. However, two years of trastuzumab had no additional benefit. This 11-year follow-up analysis thus provides the long-term data needed to support the use of 1 year of adjuvant trastuzumab in this patient population. Furthermore, there was no increase in the rate of serious toxicity over time for patients assigned to receive trastuzumab, either for 1 or for 2 years.

As noted in the paper, to our knowledge, this 11-year follow-up of the HERA trial provides the longest survival data of any trial that assessed the addition of anti-HER2 therapy to standard treatment for women with Human Epidermal Growth Factor Receptor (HER)2-Positive early breast cancer.

About HERA

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. HER2-positive breast cancer is a particularly aggressive form of the disease that previously meant poor survival rates.

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.

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 (link) – 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.

 

Publication: 11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Cameron D, Piccart-Gebhart MJ, Gelber RD, Procter M, Goldhirsch A, de Azambuja E, Castro G Jr, Untch M, Smith I, Gianni L, Baselga J, Al-Sakaff N, Lauer S, McFadden E, Leyland-Jones B, Bell R, Dowsett M, Jackisch C; Herceptin Adjuvant (HERA) Trial Study Team. Lancet 389:1195-1205, 2017 (IBCSG 28-02) (Journal impact factor 44.002)