Medical community recognise significance of Herceptin® results in early HER2-positive breast cancer

10/20/05

Landmark adjuvant breast cancer trial published in New England Journal of Medicine

Brussels, Belgium (20 October) – Today, the New England Journal of Medicine (NEJM) reports that the administration of Herceptin® (trastuzumab) following standard chemotherapy significantly reduces the risk of disease recurrence for women with early-stage HER2-positive breast cancer by 46%.

The interim results from the international HERA (HERceptin Adjuvant) study provide new hope in the fight against HER2-positive breast cancer, a more aggressive form of the disease affecting approximately 20 – 30% of women with breast cancer . The HERA study is one of the largest breast cancer trials ever carried out, with more than 5,000 patients in 39 countries. The study allowed the use of a wide range of chemotherapy regimens before treatment with Herceptin, making the results relevant to many parts of the world.

Dr Martine Piccart, lead investigator of the HERA study and Chair of the Breast International Group (BIG), commented, "Breast cancer is a serious and sometimes life-threatening disease, but with appropriate and timely treatment in the early stages, many women can improve their chances of long-term survival. For women with early-stage HER2-positive breast cancer, results from the HERA study provide some much needed optimism. The study showed that Herceptin, a drug designed specifically for HER2-positive breast cancer, can remarkably reduce the risk of cancer returning." Dr. Piccart added, "I can't stress enough how crucial it is that all patients' breast tumours are tested appropriately at initial diagnosis, and if patients are HER2-positive, that they have access to Herceptin."

Results from a joint interim analysis of over 3,000 patients from two North American trials provided similar remarkable results for Herceptin in early-stage HER2-positive breast cancer, and were also published in the NEJM today. These data, at a median follow-up of two years, show 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.

The strength of the results from the HERA study has influenced medical and regulatory organizations around the world to act urgently to ensure access to Herceptin for early-stage HER2-positive breast cancer patients. Several countries are already developing clinical guidelines and committing funding to allow eligible patients faster access, prior to license.

About the HERA study

HERA, conducted by the Breast International Group (BIG) and Roche , is one of the largest adjuvant studies ever carried out among breast cancer patients; enrolment to the trial began in December 2001, and nearly 5,100 HER2-positive patients were enrolled at 480 sites in 39 countries across the world. HERA is a randomised trial, which, following standard adjuvant systemic chemotherapy and radiotherapy (if applicable), evaluates observation versus Herceptin every three weeks for 12 months or 24 months in women with early-stage HER2-positive breast cancer. The HERA study allowed for the use of a wide range of chemotherapy regimens, and both lymph node-positive and lymph node-negative patients were eligible for entry into the trial.

According to the interim analysis, the primary efficacy endpoint was met, showing that in both 12- and 24-month arms, patients who received Herceptin had a statistically significant improvement in disease-free survival (the length of time after treatment during which no disease is found). At a median follow-up of one year, the secondary endpoint of overall survival had not reached statistical significance, but an improvement in overall survival is also possible as the data mature.

The NEJM article provides the results of the comparison between 12 months of Herceptin versus observation, but not a comparison of 12 months versus 24 months treatment duration. The trial will continue to assess this comparison and data are expected in 2008.

All study data are managed by a Brussels-based BIG member group, the Breast European Adjuvant Studies Team (BrEAST), with independent statistical analysis carried out in Boston and Scotland by the non-profit research organization, Frontier Science. The HERA study also has an external Independent Data Monitoring Committee (IDMC) that regularly reviews safety data. No safety concerns were raised by the IDMC, and the incidence of congestive heart failure was very low (0.5% in the Herceptin arm vs. 0% in the observation arm). Patients in this study will continue to be followed for any side effects for up to ten years.

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