The Trial Assessing Individualized Options for Treatment (TAILORx), an ongoing randomized clinical trial, is testing the benefit of adjuvant chemotherapy in women with early stage breast cancer selected using a molecular profiling assay.
Prior studies have validated that Oncotype DX®, a molecular profiling test that analyzes the expression of a 21-gene panel in biopsy samples from women with estrogen-dependent, lymph-node negative breast cancer, can predict the risk of breast cancer recurrence. The studies also appear to identify which of those patients will benefit most from chemotherapy. Currently, chemotherapy is recommended for most women with this type of breast cancer, many of whom may be adequately treated with hormone therapy alone. The NCI-sponsored cooperative groups are conducting TAILORx to determine whether hormonal therapy alone is inferior to the standard of chemotherapy plus hormonal therapy in women with estrogen-dependent, lymph-node negative breast cancer. To date, over 2,300 women have been enrolled in this study with an additional 2,300 registered. The results of this study could potentially show that many women can be spared the short- and long-term toxic effects and costs of chemotherapy each year.