According to Mayo Clinic medical oncologist and NCCTG study chair Edith Perez, M.D., these results could change the standard of care for thousands of women with breast cancer.
"Women with HER-2 positive breast cancer had a high risk of the cancer returning and of dying from breast cancer. This intervention -- chemotherapy plus trastuzumab -- essentially changes the natural history of the disease," says Dr. Perez.
The National Cancer Institute (NCI) sponsored two large, multicenter clinical trials studying more than 3,300 women with breast cancer between February 2000 and April 2005. These two Phase III trials were conducted by NCCTG and the National Surgical Adjuvant Breast and Bowel Project (NSABP), in collaboration with other research groups throughout the United States.
Dr. Perez, from Mayo Clinic in Jacksonville, Fla., will report results from the NCCTG trial (N9831) on Monday, May 16, at the 2005 American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Fla.
The NCCTG trial is the only study that will offer new data comparing whether trastuzumab is more effective in preventing recurrence when it's given during (concurrently) or after (sequentially) chemotherapy. These findings will be important tools to help oncologists determine how to optimize trastuzumab's protective effect in the course of treating patients with HER-2 positive breast cancer.
"Our preliminary data show that sequential treatment is good, but trastuzumab given concurrently with chemotherapy yielded important trends for better results. Although longer follow-up is needed, this difference led to the recommendation that study participants who are cu