THE HERA CLINICAL TRIAL

Reducing the Risk of Breast Cancer Returning

The HERA clinical trial was a ground-breaking clinical trial for women with HER2-positive breast cancer, which showed that the drug trastuzumab (Herceptin) can significantly reduce the risk of breast cancer returning. The results of this trial were published in the New England Journal of Medicine (NEJM), which reported that the administration of Herceptin following standard chemotherapy reduces the risk of the disease returning for women with early stage HER2-positive breast cancer by 46%.

The results of HERA provided new hope for women with HER2-positive breast cancer, which is a more aggressive form of the disease affecting approximately 20-30% of women with breast cancer. The study allowed for the use of a wide range of chemotherapy regimens before treatment with Herceptin, making the results relevant to many parts of the world.

HERA was one of the largest adjuvant studies ever carried out among breast cancer patients and enrolment began in 2001. HERA was conducted in Australia and New Zealand by Breast Cancer Trials, in collaboration with the International Breast Cancer Study Group and the Breast International Group. More than 5,000 women from 39 countries participated in the study worldwide, including 110 patients from Australia and New Zealand. It was the first time that Australian centres had participated in a trial of a biological agent in the adjuvant setting (treatment that is given in addition to initial or primary therapy).

Breast Cancer Trials Study Chair of the HERA clinical trial, Associate Professor Nicholas Wilcken, says the results of HERA was one of the most important breakthroughs for breast cancer in clinical trials.

“The results of HERA clearly showed that the addition of Herceptin produces a better outcome for those women with early stage HER2-positive breast cancer and changed practice around the world,” Associate Professor Wilcken said.

Results from a joint interim analysis of over 3,000 patients from two North American trials provided similar and equally remarkable results for Herceptin in early-stage HER2-positive breast cancer and were also published in the NEJM. This data, at a median follow-up of two years, showed that Herceptin in combination with a specific chemotherapy regimen provided a 52% reduction in risk of cancer coming back as well as a 33% reduction in risk of death.