Recruitment for Trial of Adjuvant Trastuzumab Under Way

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

The Breast International Group and Roche are collaborating toconduct the Herceptin Adjuvant (HERA) Study, and it is anticipated thatrecruitment will continue for over 48 months. More than 20,000 women with earlybreast 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 andimprove quality of life in patients with metastatic breast cancer who stronglyexpress 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 survivalat an earlier stage of the disease.

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

In patients randomized to receive trastuzumab, treatment will beadministered sequentially after completion of surgery, established chemotherapy,and, if indicated, radiotherapy. Patients recruited for the study must have haddefinitive breast cancer surgery, completed their chemotherapy, and haveHER2-positive disease.

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