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U.S. National Institutes of Health
Cancer Diagnosis Program Cancer Imaging Program Cancer Therapy Evaluation Program Developmental Therapeutics Program Radiation Research Program Translational Research Program Biometric Research Branch Office of Cancer Complementary and Alternative Medicine
Last Updated: 04/25/2012


Trial Assigning Individualized Options for Treatment


Tracy Lively, Ph..D.

The Trial Assigning Individualized Options for Treatment (TAILORx), the first trial launched by PACCT, is testing whether a set of expressed genes that has been shown to be associated with risk of recurrence in women with node-negative, hormone receptor-positive breast cancer can be used to assign patients to the most appropriate and effective treatment. The signature being tested is the 21-gene Oncotype DX® panel developed by Genomic Health, Inc., in collaboration with an NCI cooperative group, the National Surgical Adjuvant Breast and Bowel Project. Details of the Oncotype DX® test were reported in the articles listed below. Breast cancer stamp sales by the US Postal Service have played a critical role in making a groundbreaking treat­ment trial possible by providing a portion of the funding for TAILORx. Without this support, the trial would not have been possible.

The trial is being carried out as a collaboration of CDP, the Cancer Therapy Evaluation Program (CTEP), and all of the NCI clinical cooperative groups that perform breast cancer studies. Accrual was completed in 2010 and follow up for outcome is ongoing.

Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, Baehner FL, Walker MG, Watson D, Park T, Hiller W, Fisher ER, Wickerham DL, Bryant J, Wolmark N. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 2004:351;2817–26.

Paik S, Tang G, Shak S, Kim C, Baker J, Kim W, Cronin M, Baehner FL, Watson D, Bryant J, Costantino J, Geyer CE, Wickerham DL, Wolmark N. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J. Clin. Oncol 2006:24;3726-34.