TAILORx Overview
The National Cancer Institute is using Oncotype DX to assign treatment to more than 10,000 breast cancer patients in landmark personalized medicine trial. Click here to learn more.
The National Cancer Institute (NCI), part of the National Institutes of Health, is using 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 and Peru in a first-of-its-kind individualized treatment trial called TAILORx (Trial Assigning IndividuaLized Options for Treatment (Rx). Coordinated by the Eastern Cooperative Oncology Group (ECOG), TAILORx is designed to evaluate the effect of chemotherapy in women with a midrange risk of their cancer returning, as determined by Oncotype DX. This trial will evaluate the effect of chemotherapy only for those with a midrange Recurrence Score, 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 will be one of the largest adjuvant treatment trials in breast cancer ever conducted, and has enrolled nearly 8,000 patients to date.
"TAILORx represents the culmination of a major initiative to integrate molecular diagnostic testing into clinical decision making," said Joseph Sparano, M.D., principal investigator for the Eastern Cooperative Oncology Group (ECOG) and director of the Breast Evaluation Center at the Montefiore-Einstein Cancer Center in New York. "This is the first trial from the NCI’s Program for the Assessment of Clinical Cancer Tests (PACCT), which seeks to individualize cancer treatment by using, evaluating and improving the latest diagnostic tests. Oncotype DX makes this trial possible by enabling us to separate women with high and low scores, whose treatment paths are clear, from those who fall in the midrange."
TAILORx Eligibility
The TAILORx trial is for women with recently diagnosed, early-stage (stage I or II) breast cancer. The cancer must be:
- Estrogen-receptor-positive and/or progesterone-receptor-positive
- HER2/neu-negative
- Lymph-node-negative
- At least 1 cm in size
Some women with tumors smaller than 1 cm may be eligible to participate if they have a higher than usual risk of relapse.
All participants must be medically appropriate candidates for chemotherapy and must agree to take chemotherapy if that is the treatment determined by the study (Recurrence Score result >25) or the study randomization (Recurrence Score result between 11 and 25).
TAILORx Insurance Coverage
In order to ensure that a broadly representative group of patients is enrolled in the TAILORx trial, the National Cancer Institute, the sponsor of the trial, has arranged to have the charge for the Oncotype DX assay covered for everyone in the study.
The charge for the Oncotype DX assay will be billed to the patient's insurance company or health benefits plan. Representatives from Genomic Health will work with insurance companies to secure reimbursement for the test. Patients will not be charged for the test if their insurance company does not pay for all or part of it, or if the patient does not have insurance.
Patients in the TAILORx trial will not receive a bill from Genomic Health for the Oncotype DX assay, but they may receive an Explanation of Benefits (EOB) from their insurance company, to advise them that a claim has been submitted.
If your patients have questions or concerns about a statement that they receive from their insurance company for the Oncotype DX assay, please call 866-ONCOTYPE (866-662-6897) toll-free.
TAILORx Resources
For a PDF overview of TAILORx, click here
For a background on this clinical trial and a list of active sites, visit the NCI Web site at www.cancer.gov/clinicaltrials/digestpage/TAILORx
For educational materials and resources on TAILORx, visit http://www.ecog.org/general/tailorx.html
The TAILORx Trial: Individualized Options for Treatment
JA Sparano
Commun Oncol. 2006;3:494-496.
Design of and Rationale for the Trial Assigning Individualized Options for Treatment (TAILORx)
JA Sparano
ASCO Educational Book. 2007;
TAILORx: Trial Assigning Individualized Options for Treatment (Rx)
JA Sparano
Clin Breast Cancer. 2006;7(4):347-350.