Source: http://www.bioon.com/industry/drug/530945.shtmlIn October 2012 1, Roche / BIOON/ - Bio Valley (Roche) and the breast International G
In October 2012 1, Roche / BIOON/ - Bio Valley (Roche) and the breast International Group (BIG) today announced the final results of a phase III HERA trial, confirmed for a period of 1 years (Hessaitin Herceptin, trastuzumab treatment), is still the standard nursing care of early HER2 positive breast cancer. These data suggest that there is no difference in the progression free survival of patients with a 1 year Hessaitin treatment, compared with the previous 2 years of the Hessaitin treatment, to the secondary end point of the study. A median follow-up of 8 years, compared with the observation group, patients received Herceptin treatment group for a period of 1 years, significant improvement in progression free survival and overall survival improvement was statistically significant. No new safety signals were found in the study.
"Herceptin has changed many HER2 positive early breast cancer patient's life, increase the chance of cure disease. HERA is one of the biggest breast cancer test, carried out the longest time, reflects the great mission we are committed to this aggressive disease, "CMO and Roche Global Product Development Director Hal Barron said. "These data answer an important question, and support the current medical practice - 1 years of Hessaitin therapy is still the standard care for patients with early HER2 positive breast cancer."
"These clinical trials help us understand how long it takes for patients to be treated, which is critical," said Dr. Martine Piccart, President of BIG. "These data provide us with evidence and confirmation that there is no need for more than 1 years of Hessaitin therapy in patients with early HER2 positive breast cancer."
HERA data will be submitted to the European Society of oncology in Vienna (ESMO), held in Austria, 2012, but also on October 1st formally submitted to the ESMO news media conference.
The results of the HERA study, originally published in 2005, when the interim analysis data showed that the study reached the primary endpoint, compared with the observation group, received a 1 year Herceptin treatment group achieved significant clinical benefits. Based on the HERA data, and 13000 cases of breast cancer patients 3 additional randomized clinical trials (NSABP B-31, NCCTG N9831, BCIRG 006) data for a period of 1 years, Herceptin therapy was approved by regulatory agencies worldwide, and international guidelines recommend, as early HER2 positive breast cancer nursing standard. So far, about 1 million 200 thousand of the world's patients have been treated with Hessaitin.
These final results confirm that Herceptin therapy for 1 years is still the standard care for early HER2 positive breast cancer. The results also show that during a mean follow-up of 8 years, in terms of progression free survival and overall survival, compared with observation group, Herceptin treatment group was statistically significant and significant improvement. No new safety signals were observed in the study. Biological Valley (bioon.com)
Compiled from: Final analysis of III HERA confirmed year of treatment as of care in early-stage HER2-positive breast cancer one standard Herceptin trial Phase