HERA Trial Follow-up Continues to Demonstrate Significant Patient Benefits From Herceptin

New 23-month follow-up data from the HERceptin Adjuvant (HERA) study, one of the largest breast cancer trials ever carried out, show that trastuzumab (Herceptin) following standard chemotherapy significantly reduced the risk of death by 34% for women with early-stage HER2-positive breast cancer. The data also show that trastuzumab continues to provide patients with a reduced risk of their cancer coming back. HER2-positive breast cancer, which affects approximately 20% to 30% of women with breast cancer, demands special and immediate attention because the tumors are fast-growing and there is a higher likelihood of relapse.

Updated Findings

The data from the international study were presented at the American Society of Clinical Oncology (ASCO) annual meeting in Atlanta. These follow-up data showed that trastuzumab taken for 12 months increases the chance of long-term survival by preventing the development of advanced disease. Similar disease-free and overall survival benefits from trastuzumab in this setting have also been seen in two large US trials, but the HERA study allowed for the use of a wide range of standard chemotherapy regimens before treatment with trastuzumab, making these results highly meaningful to many parts of the world.

Professor Ian Smith, Head of the Breast Unit at Royal Marsden Hospital, London, and investigator of the HERA study, commented, "These significant survival results for Herceptin in early breast cancer are very important. Last year's HERA results showed that Herceptin could reduce the risk of recurrence; now we have confirmation for the first time that this means a better chance of staying alive. HER2-positive breast cancer is a more aggressive form of the disease, and it is very important that women diagnosed with early breast cancer have a HER2 test to see if they would benefit from Herceptin."

Study Synopsis

The HERA study is a randomized phase III trial that evaluated the use of trastuzumab vs observation following a wide range of primary chemotherapy (chemotherapy given before or after surgery) and radiotherapy (if applicable) for 12 or 24 months in women with early-stage HER2-positive breast cancer. The 23-month follow-up data show that patients who received trastuzumab in the 12-month arm had statistically significant reductions in the risk of death (hazard ratio [HR] = 0.66), as well as the risk of cancer coming back (HR = 0.64).

Roche filed for an indication for trastuzumab in early-stage HER2-positive breast cancer in February 2006 based on the interim analysis of the 12-month arm of the HERA data. The European Commission granted approval for this indication on May 22, 2006.