What is TAILORx?
For information on the ongoing TAILORx clinical study, click on the links below.
For a PDF overview of TAILORx, click here.
For information on Genomic Health’s pipeline, click here.
TAILORx Overview
The Oncotype DX assay plays a central role in the Trial Assigning IndividuaLized Options for Treatment (Rx) (the TAILORx clinical trial), which is sponsored by the National Cancer Institute and administered by the Eastern Cooperative Oncology Group.
By integrating the Oncotype DX assay, a molecular diagnostic test, into the clinical decision-making process, healthcare professionals and their patients will be able to make more informed treatment decisions. The TAILORx trial is designed to determine whether physicians may be able to avoid chemotherapy treatment in women who are not to have recurrence of their disease with hormonal-therapy alone. Avoiding chemotherapy may spare these patients from associated serious side effects, such as nausea, hair loss and fatigue. Physicians may also be able to reduce inadequate treatment by identifying women who are likely to derive significant benefit from chemotherapy and encouraging those women to undergo chemotherapy.
TAILORx is one of the largest clinical trials that will be conducted in women with early-stage breast cancer and will include over 1,000 sites and is expected to accrue over 10,000 patients.
TAILORx Objectives
Primary Objectives
- To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal therapy in women whose tumors meet established clinical guidelines for adjuvant chemotherapy and fall in the "uncertain chemotherapy benefit" category (Oncotype DX Assay Recurrence Score® result of 11 to 25). The primary study endpoint is disease-free survival. Other co-primary endpoints include distant recurrence-free interval, recurrence-free interval and overall survival
- To create a tissue and specimen bank for patients enrolled in this trial, including formalin-fixed, paraffin-embedded tumor specimens, tissue microarrays, plasma and DNA obtained from peripheral blood. This resource will be critical for evaluating emerging clinical cancer tests
Secondary Objectives
- To determine whether adjuvant hormonal therapy is sufficient treatment (i.e., 10-year distant disease-free survival of at least 95%) for women whose tumors meet established clinical guidelines for adjuvant chemotherapy and who fall into the "no or minimal chemotherapy benefit" category (Oncotype DX Assay Recurrence Score result ≤10)
- To compare the outcomes projected at 10 years by Adjuvant! (with outcomes projected using classical pathologic information including tumor size, hormone-receptor status and histologic grade) with those made by the Oncotype DX assay. Classical pathologic information and outcome results will also be used to create and refine models that would use classical information instead of, or in combination with, genomic tests
- To estimate failure rates as a function of Recurrence Score result separately in the chemotherapy and no chemotherapy groups. The purpose of the analysis is to develop more precise estimates of the relationship between Recurrence Score result and chemotherapy treatment effect, if any, at the upper range of the "uncertain chemotherapy benefit" group
- To determine the prognostic significance of the Oncotype DX Assay Recurrence Score result and of the individual Recurrence Score result gene groups (proliferation gene group, HER2 gene group, ER gene group, invasion gene group and other genes)
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).
For eligibility questions, please contact ECOG at ecog.tailorx@jimmy.harvard.edu.
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: Why the Oncotype DX Assay?
The Oncotype DX assay is being used by the NCI in the TAILORx trial because1:
- It is a standardized, multi-gene RT-PCR-based molecular diagnostic assay performed in a single laboratory
- The Genomic Health laboratory that performs the Oncotype DX assay is certified under the federal Clinical Laboratory Improvement Amendments (CLIA), accredited by the College of American Pathologists and licensed by applicable state agencies in the United States
- It may be performed on formalin-fixed, paraffin-embedded tissue specimens routinely processed and stored in clinical pathology laboratories
- It has been validated to assess the likelihood that breast cancer will recur in a woman diagnosed with stage I or II, ER-positive, node-negative disease
- The Recurrence Score result algorithm has been validated as quantifying the likelihood of distant recurrence in tamoxifen-treated patients with node-negative, estrogen-receptor-positive breast cancer.
- The pivotal validation study was performed on samples from the NSABP Study B-14. This validation study was published in 2004 in The New England Journal of Medicine
- The assay was further validated in a large, population-based study conducted by Kaiser Permanente
- Another study, published in the Journal of Clinical Oncology, was based on samples from the NSABP Study B-20 and indicated that that the Oncotype DX assay can predict the likelihood of benefit from adjuvant chemotherapy
- Sparano JA. TAILORx: Trial Assigning Individualized Options for Treatment (Rx). Clinical Breast Cancer, Vol. 7, No.4.347-350, 2006.
TAILORx Sponsor
The TAILORx clinical trial is sponsored by the National Cancer Institute’s program for the Assessment of Clinical Cancer Tests (PACCT-1) and administered by the Eastern Cooperative Oncology Group (ECOG).
All of the NCI-sponsored clinical trial groups that perform breast cancer research have collaborated in the trial's development and are participating in this study. They include:
- The Eastern Cooperative Oncology Group (ECOG)
- The Southwest Oncology Group (SWOG)
- The North Central Cancer Treatment Group (NCCTG)
- The Cancer and Leukemia Group B (CALGB)
- The American College of Surgeons Oncology Group (ACOSOG)
- The National Surgical Breast and Bowel Project (NSABP)
- National Cancer Institute of Canada (NCIC)
TAILORx Additional Information
Eastern Cooperative Oncology Group (ECOG) Materials
ECOG physician and patient education materials regarding TAILORx—main page: http://www.ecog.org/general/tailorx.html
Physician Resources
PACCT-1: TAILORx Fast Facts (one-page overview): http://www.ecog.org/general/gendocs/tailorx_fastfacts.pdf
Patient Educational Resources
Understanding PACCT-1: TAILORx:http://www.ecog.org/general/gendocs/tailorx_brochure.pdf
TAILORx Breast Cancer Clinical Trial Announcement: http://www.ecog.org/general/gendocs/tailorx_1page.pdf
Oncotype DX Assay Fact Sheet: http://www.ecog.org/general/gendocs/tailorx_oncodxfact.pdf
TAILORx Randomization Fact Sheet: http://www.ecog.org/general/gendocs/tailorx_randofact.pdf
TAILORx Treatment Options Fact Sheet: http://www.ecog.org/general/gendocs/tailorx_treat_opt.pdf
National Cancer Institute (NCI) Materials
TAILORx press release: http://www.cancer.gov/newscenter/pressreleases/TAILORxRelease
NCI materials regarding TAILORx—main page: http://www.cancer.gov/clinicaltrials/digestpage/TAILORx
ClinicalTrials.gov Materials
TAILORx trial overview and locations: http://www.clinicaltrials.gov/ct/show/NCT00310180?order=1
Coalition of Cancer Cooperative Groups Materials
TAILORx trial locations: http://www.trialcheck.org/cancertrialshelp/cancertrialshelp.aspx?intAppMode=3&intProtocolUID=22785
TAILORx Contact Information
For eligibility questions regarding the TAILORx trial http://www.trialcheck.org/cancertrialshelp/cancertrialshelp.aspx?intAppMode=3&intProtocolUID=22785
Eastern Cooperative Oncology Group (ECOG)
ecog.tailorx@jimmy.harvard.edu
www.ecog.org
For protocol and general information
Clinical Trials Support Unit (CTSU)
1-888-823-5923 CTSUcontact@westat.com
www.ctsu.org
For information on the Oncotype DX Assay
Genomic Health Customer Service
866-ONCOTYPE (866-662-6897)