The TAILORx Breast Cancer Trial

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The Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, is examining 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.

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. TAILORx is one of the first trials to examine a methodology for personalizing cancer treatment.

The study has randomized approximately 7,000 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 that had not yet spread to the lymph nodes were eligible for the study. (See a summary of the TAILORx protocol for more information.)

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 (now the ECOG-ACRIN Cancer Research Group). 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.