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Recruitment for Trial of Adjuvant Trastuzumab Under Way

Recruitment for Trial of Adjuvant Trastuzumab Under Way

Recruitment for a challenging breast cancer trial has begun at sites in more than 40 countries. It is hoped that more than 3,000 patients from approximately 600 sites will participate in a study designed to determine whether earlier use of trastuzumab (Herceptin) increases disease-free survival in women with early breast cancer.

The Breast International Group and Roche are collaborating to conduct the Herceptin Adjuvant (HERA) Study, and it is anticipated that recruitment will continue for over 48 months. More than 20,000 women with early breast cancer will need to be tested for HER2 expression to meet this goal.

Disease-Free Survival Assessment

Trastuzumab has already been shown to increase survival and improve quality of life in patients with metastatic breast cancer who strongly express HER2-positive disease (Slamon J et al: N Engl J Med 344:783-792, 2001). In this study, investigators will assess improvements in disease-free survival at an earlier stage of the disease.

"HERA is one of the most challenging studies ever carried out in the treatment of breast cancer and, therefore, its results will be of great significance to the way in which patients are treated in the future," said Dr. Martine Piccart, chair of The Breast International Group and head of the chemotherapy department at the Jules Bordet Institute in Brussels. "We hope that positive results will mean a greater number of patients will be able to take advantage of the benefits associated with Herceptin treatment."

In patients randomized to receive trastuzumab, treatment will be administered sequentially after completion of surgery, established chemotherapy, and, if indicated, radiotherapy. Patients recruited for the study must have had definitive breast cancer surgery, completed their chemotherapy, and have HER2-positive disease.

For more information on the trial, visit www.her2status.com or contact Carrie Monaghan at carrie.monaghan
@ketchum.com or Rina Amin at rina.amin@ketchum.com.

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