The trial assigning individualized options for Treatment (Rx), or TAILORx, was launched to examine whether genes that are frequently associated with risk of recurrence for women with early-stage breast cancer can be used to assign patients to the most appropriate and effective treatment.

TAILORx is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and is coordinated by the Eastern Cooperative Oncology Group (ECOG). All of the NCI-sponsored clinical trials groups that perform breast cancer research studies have collaborated in the trial's development and are participating in this study.

"This trial is important because it is one of the first to examine a methodology for personalizing cancer treatment," said NIH director Elias A, Zerhouni.

The majority of women with early-stage breast cancer are advised to receive chemotherapy in addition to radiation and hormonal therapy, yet research has not demonstrated that chemotherapy benefits all of them equally. TAILORx seeks to incorporate a molecular profiling test (a technique that examines many genes simultaneously) into clinical decision making, and thus spare women unnecessary treatment if chemotherapy is not likely to be of substantial benefit to them. The study will enroll over 10,000 women at 900 sites in the United States and Canada. Women recently diagnosed with estrogen receptor and/or progesterone receptor positive, Her2/neu negative breast cancer, which has not yet spread to the lymph nodes, are eligible for the study. Overexpression of the Her2/neu gene carries poorer prognosis for patients.

TAILORx will determine the most effective current approach to cancer treatment, with the fewest side effects, for women with early-stage breast cancer by using Oncotype DX, a validated diagnostic test developed by Genomic Health, Inc., Redwood City, California in collaboration with the National Surgical Adjuvant Breast and Bowel Project (NSABP), a network of cancer research professionals. TAILORx is the first trial to be launched as part of a new NCI program--, the Programme for the Assessment of Clinical Cancer Tests (PACCT), which seeks to individualize cancer treatment by using, evaluating and improving the latest diagnostic tests.

"A large number of these women are receiving toxic chemotherapy unnecessarily, and we need a means of identifying them," said Jo Anne Zujeweski, senior investigator in the clinical investigation branch of NCI's Cancer Therapy Evaluation Programme. "TAILORx could help change the way we treat breast cancer and improve the quality of patients' lives, helping to better identify women who are likely to benefit from chemotherapy from those who are not," he added.