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® Recurrence Score® result. The trial also seeks to determine whether there is an optimal 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 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 Recurrence Score results in this range.
The use of Oncotype DX 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 Oncotype DX for the RxPONDER trial click here.
Beginning in May of 2006, in a first-of-its-kind individualized treatment trial called TAILORx (Trial Assigning IndividuaLized Options for Treatment (Rx)), the National Cancer Institute (NCI) part of the National Institutes of Health, initiated a landmark trial which used Oncotype DX to identify and assign treatment to more than 10,000 breast cancer patients from 1,500 sites in the United States, Canada, Ireland, Peru and Australia. Coordinated by the Eastern Cooperative Oncology Group (ECOG), TAILORx was designed to evaluate the effect of chemotherapy in women with a midrange risk of their cancer returning, as determined by the Oncotype DX Breast Cancer Assay. The trial evaluates the effect of chemotherapy only for those with a midrange Recurrence Score® result, as previous Oncotype DX studies have already confirmed the benefit of adjuvant chemotherapy for those in the high Recurrence Score range and minimal, if any, benefit for those in the low Recurrence Score range. TAILORx is one of the largest adjuvant treatment trials conducted in the breast cancer field and has enrolled over 10,000 patients. The TAILORx trial is ongoing, but not recruiting patients and results are anticipated in 2016-17. For further information regarding TAILORx and closure of the trial, please visit the ECOG website.