TAILORx Trial Reports Positive Results: 99% of women with low Oncotype DX® Breast Recurrence Score™ results are free of breast cancer recurrence after five years of hormone therapy alone.
On September 28, 2015, initial results were announced from the Trial Assigning IndividuaLized Options for
Treatment (Rx), or TAILORx, a multi-center prospectively conducted trial of more than 10,000 women with early stage breast cancer sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) with support from Genomic Health, Inc. The study demonstrated that a group of trial participants with low 21-gene recurrence score (Breast Recurrence Score results of 10 or less who received hormonal therapy alone without chemotherapy had less than a one percent chance of distant recurrence at five years.
This finding, published online by the New England Journal of Medicine, provides evidence that other women in the future may effectively use hormonal therapy alone if the Breast Recurrence Score is 10 or less. Second primary cancers exceeded recurrences of the original breast cancer, resulting in 93.8 percent five year disease free survival, the primary trial endpoint.
“This prospective study involving uniformly treated patients with hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer supports the clinical validity of the 21-gene assay in identifying patients who may be safely spared adjuvant chemotherapy.”1
For more information regarding the TAILORx trial, please visit the TAILORx results, the abstract of the TAILORx study, and the New England Journal of Medicine.
1. Sparano et al. New Engl J Med. 2015. Prospective Validation of 21-Gene Expression Assay in Breast Cancer New Engl J Med
RxPONDER Trial (SWOG S1007)
Opened in January 2011, the RxPONDER Trial (Rx for Positive Node, Endocrine Responsive Breast Cancer) will reveal whether chemotherapy benefits patients with node positive breast cancer who have low to intermediate Oncotype DX Breast Recurrence Score result. The trial also seeks to determine whether there is an optimal Breast Recurrence Score cutpoint for these patients, above which chemotherapy should be recommended.
The trial is being conducted by SWOG with the participation of all the major National Cancer Institute-funded cooperative groups in the United States.
Researchers plan to enroll 4,000 women with Breast Recurrence Score results of 25 or less who have early stage, hormone receptor-positive, HER2-negative breast cancer that has been found to involve one to three lymph nodes. They expect to screen over 9,000 breast cancer patients to identify 4,000 with Breast Recurrence Score results in this range.
The use of the Breast Recurrence Score in patients with node-positive breast cancer has been validated in several studies including a previous SWOG led-study, SWOG 8814, ECOG 2197 and TransATAC. The test has been available for use by physicians in clinical practice for node-positive disease since 2008, and it has been reimbursed selectively in the U.S. for this patient population.
For further information regarding the RxPONDER trial, please visit the SWOG website.
For questions on how to order the Breast Recurrence Score for the RxPONDER trial click here.