Oct. 1, 2012 /BIOON, Oct. 1, 2012/ – Roche and Breast International (BIG) today announced final results from the Phase III HERA trial, confirming that 1-year Herceptin (trastuzumab) treatment remains the standard of care for early-stage HER2-positive breast cancer. These data indicate that there was no difference in progression-free survival between 1 year of Herceptin treatment and 2 years of Herceptin treatment, meeting the study’s secondary endpoint. A mean follow-up of 8 years found statistically significant improvements in disease progression-free survival and overall survival in the group of patients treated with 1 year of Herceptin compared to the observation group. There were no new safety signals in the study. ”Herceptin has transformed the lives of many patients with HER2-positive early-stage breast cancer, increasing the chances of a cure for the disease. hERA is one of the largest and longest-running breast cancer trials to date and reflects our commitment to the great mission of this very aggressive disease,” said Hal said Dr. Barron. “These data answer a very important question and support current medical practice – 1-year Herceptin treatment remains the standard of care for patients with early-stage HER2-positive breast cancer.” ”These clinical trials, help us understand just how long a patient needs to receive a specific treatment, which is critical,” said BIG President Martine Piccart, MD. “These data give us relevant evidence & reconfirmation that there is no need to treat patients with early stage HER2-positive breast cancer with Herceptin for more than 1 year.” The HERA data will be presented at the 2012 European Society of Medical Oncology (ESMO) in Vienna, Austria, and also formally presented at the ESMO press conference on Oct. 1. Results from the HERA study, originally published in 2005 when data from the interim analysis showed that the study met its primary endpoint and achieved a significant clinical benefit in the group receiving 1 year of Herceptin treatment compared to the observation group. Based on the HERA data, and data from three additional randomized clinical trials (NSABP B-31, NCCTG N9831, BCIRG 006) involving 13,000 breast cancer patients, 1-year Herceptin therapy was approved by global regulatory agencies and recommended by international guidelines as the standard of care for early-stage HER2-positive breast cancer. To date, approximately 1.2 million patients worldwide have been treated with Herceptin. HERA Study Results These final results confirm that 1-year Herceptin therapy remains the standard of care for early-stage HER2-positive breast cancer. The study results also showed that after a mean follow-up of 8 years, there was still a statistically significant improvement in progression-free disease survival and overall survival in the Herceptin-treated group compared to the observation group. No new safety signals were observed in the study.