The European Commission has approved Herceptin ( Trastuzumab ) for patients with early-stage HER2-positive breast cancer following surgery and standard chemotherapy.

The approval is based on impressive results from the international HERA ( HERceptin Adjuvant ) study which showed Herceptin following standard chemotherapy significantly reduces the risk of cancer coming back by 46% compared to chemotherapy alone.
Similarly remarkable benefits have also been seen in three other major global and US studies.

Herceptin was previously approved in the EU for the treatment of metastatic ( advanced ) HER2-positive breast cancer, so this new approval allows women with all stages of this aggressive disease, including early-stage breast cancer, to access this life-extending treatment option.

(FDA) on February 15th, 2006. The application is based on data from the combined interim analysis of two large US trials,4 and Genentech has received a priority review designation.
HERA 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 the 12-month arm, patients who received Herceptin had a statistically significant improvement in disease-free survival.
At a median follow-up of one year, the secondary endpoint of overall survival had not reached statistical significance, but showed a clear trend towards an improvement in overall survival.

The interim analysis compared Herceptin versus observation and did not include a comparison of 12 months versus 24 months treatment duration. The trial will continue to assess this comparison and data will become available in due time as the study matures.

The HERA study 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 arms vs. 0% in the observation arm ).
Patients in this study will continue to be followed for any side effects.

In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as ‘HER2 positivity.’ High levels of HER2 are present in a particularly aggressive form of the disease which responds poorly to chemotherapy.
Research shows that HER2-positivity affects approximately 20-30% of women with breast cancer.

Herceptin is a humanised antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. In addition to its efficacy in the early-stage breast cancer setting,
Herceptin also has demonstrated improved survival in the advanced ( metastatic ) setting, where its addition to chemotherapy allows patients to live up to one-third longer than chemotherapy alone.

Source: Roche, 2006


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