"By using a molecular diagnostic test to assess whether a breast tumor will respond to chemotherapy, we're hoping to more precisely identify which patients can be adequately treated with hormonal therapy alone and which patients will truly benefit if chemotherapy is added to the treatment," said Joseph Sparano, MD, who directs the Breast Evaluation Center at the Montefiore-Einstein Cancer Center. "With better individualized treatment, we can spare women the side effects of chemotherapy where it is unnecessary."
Dr. Sparano is the lead investigator for the clinical trial, called TAILORx (an acronym for Trial Assigning Individualized Options for Treatment). The study, sponsored by the National Cancer Institute, will enroll about 10,000 women with breast cancer at more than 900 institutions throughout the United States and Canada.
Breast cancer is the most frequently diagnosed cancer in women, with an estimated 235,000 new cases of invasive breast cancer expected in the United States and Canada in 2006. Nearly 140,000 of these women will have estrogen receptor-positive breast cancer that has not yet spread to the lymph nodes.
The standard treatment is surgery to remove the tumor, plus radiation and hormonal therapy, which cures about 80 to 85 percent of patients. Adding chemotherapy can further reduce the risk of recurrence by about 25 percent, but it benefits only a small proportion of women.
Currently, most women with early-stage breast cancer are advised to undergo chemotherapy, yet it's not clear that chemotherapy is worthwhile or even necessary in all these cases," Dr. Sparano said.
The researchers will use OncotypeDXTM, a modern diagnostic test developed by Genomic Health, Inc., in Redwood, Calif.,
Contact: Sharon Butler
Rubenstein Associates, Inc.