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