From rxpgnews.com

Breast
HERA study Confirms Herceptin’s Potential
By Roche, Genentech and Breast International Group (BIG)
Apr 28, 2005, 18:33

Roche, Genentech and Breast International Group (BIG)1 today announced that the interim analysis of HERA (HERceptin Adjuvant), a large scale, 39-country, phase III study with a wide range of chemotherapy regimens shows that the addition of Herceptin (trastuzumab) significantly increases disease-free survival for women with early-stage HER2-positive breast cancer.

These results come only two days after a joint interim analysis of two North American trials in early-stage breast cancer reported similarly impressive benefits for patients receiving Herceptin. These studies provide consistent evidence that Herceptin can reduce the risk of cancer coming back for women with early-stage HER2-positive breast cancer. HER2-positive breast cancer affects approximately 20 – 30% of women with breast cancer and is a particularly aggressive form of the disease which has a poor prognosis.2

“The combined data from over 8,000 patients analysed so far make a compelling case for Herceptin as an optimal treatment in HER2-positive early breast cancer and has potential to change the way breast cancer is managed,” said William M. Burns, CEO of Roche’s Pharmaceuticals Division. “This news represents an important milestone in the fight against this aggressive type of breast cancer and a real step forward for patients who previously faced a poor outlook. Based on these impressive results, we will work closely with health authorities around the world to make Herceptin accessible for early-stage HER2-positive breast cancer patients as soon as possible.”

The HERA study, conducted by Roche and BIG, evaluated the use of Herceptin versus observation following a wide range of primary chemotherapy (chemotherapy given before or after surgery) and radiotherapy (if applicable). An interim analysis met its primary efficacy endpoint by showing that patients who received Herceptin had statistically significant improvement in disease-free survival (the length of time after treatment during which no disease is found). The secondary endpoint of overall survival has not yet been reached, possibly due to short follow up. Patients in the study will continue to be monitored, and an improvement in overall survival is possible to be achieved as the data mature. The HERA Steering Committee will work to submit data from this phase III trial for presentation at an upcoming medical meeting in 2005.

Dr Martine Piccart, Head of the Medicine Department at the Jules Bordet Institute in Brussels and lead investigator of the HERA study, commented, “To date, HERA is one of the biggest studies ever conducted among breast cancer patients, and we are very pleased that the study has shown such significant clinical benefits for this patient population. It is now crucial that testing for HER2 status becomes standard for all women at primary diagnosis of breast cancer to ensure that all women with HER2-positive disease have the chance to benefit from this important drug.”

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