What is TAILORx?
TAILORx Overview
The Oncotype DX® test is being used in clinical practice. At the same time, research involving the test is ongoing to learn more about the use of the test. The Oncotype DX test plays a key role in the clinical trial, the Trial Assigning IndividuaLized Options for Treatment (Rx), known as TAILORx. Participants are being divided into different treatment groups depending on their Recurrence Score® results. Patients with Recurrence Score results less than 11, who are at low risk for recurrence and for whom chemotherapy is expected to provide little benefit, will receive hormone therapy alone. Patients with Recurrence Score results greater than 25, who are at higher risk for recurrence and for whom chemotherapy is expected to provide substantial benefit, will receive hormonal therapy and chemotherapy. Patients with Recurrence Score results between 11 and 25, whose risk for recurrence is intermediate and for whom the benefit of chemotherapy is unclear will be randomized to treatment with hormonal therapy plus chemotherapy versus hormonal therapy alone. The range for this trial was adjusted from the commercial product to minimize the potential for undertreatment in the high risk group and the randomized group. The primary objective of the trial is to determine whether hormonal therapy alone offers no less benefit than chemotherapy plus hormonal therapy in women whose Recurrence Score results range from 11 to 25.
The study will enroll more than 10,000 women at 900 sites in the U.S. and around the world. Women eligible for the study are those recently diagnosed with estrogen-receptor-positive and/or progesterone-receptor-positive, Her2/neu-negative breast cancer that has not yet spread to the lymph nodes.
TAILORx is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and is coordinated by the Eastern Cooperative Oncology Group (ECOG). All of the NCI-sponsored clinical trials groups that perform breast cancer research studies have collaborated in the trial’s development and are participating in this study.
If you have just been diagnosed with early-stage breast cancer, you and your doctor may want to talk about whether this clinical trial could be right for you.
TAILORx FAQs
1. What is the purpose of the trial?
TAILORx—the Trial Assigning IndividuaLized Options for Treatment (Rx)—is designed to determine whether adjuvant hormonal therapy alone is as effective as adjuvant hormonal therapy in combination with chemotherapy for women with early-stage breast cancer. The trial is designed to help physicians personalize treatment for each breast cancer patient in a way that improves outcomes.
2. Who is eligible to enroll in TAILORx?
Women with estrogen-receptor- and/or progesterone-receptor-positive, lymph-node-negative (cancer that has not spread to the lymph nodes), HER2/neu-negative breast cancer are eligible to enroll in TAILORx. The tumor size must be 1.1 to 5.0 cm (or 0.5 mm to 1.0 cm, with unfavorable histologic features). Participants must be medically suitable candidates for adjuvant chemotherapy.
If you have just been diagnosed with early-stage breast cancer, you may want to ask your doctor if you are a candidate for the TAILORx trial.
3. What does the trial involve?
All patients who agree to participate in the trial will have the Oncotype DX test performed on a sample of the tumor that has already been removed and is stored at the facility where the sample was collected. This test does not require an additional biopsy or other procedures. The specimen will be sent to Genomic Health for testing. It takes about 10 to 14 days from the time a specimen is received at Genomic Health for a doctor to get the result of the test. These results will be used to guide treatment in accordance with the protocol. Click here to learn more about the Oncotype DX test process.
4. What are the primary objectives of the trial?
The primary objectives of TAILORx are two-fold:
- To determine whether adjuvant hormonal therapy with chemotherapy is better than adjuvant hormonal therapy alone in women whose tumors fall in a range in which the benefit from chemotherapy is uncertain as indicated by a molecular test. The primary study endpoint is disease-free survival. Another primary endpoint is 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.
5. How will the Oncotype DX test be used to guide therapy in this trial?
The test result is expressed as a Recurrence Score result. The higher the score, the greater the chance of having a recurrence of breast cancer if a woman is treated with hormonal therapy alone. The treatment that patients will receive in this trial will depend upon the Recurrence Score results.
- If the Recurrence Score result is 10 or less, it is estimated that approximately 95 percent of patients or more may live long-term without a distant disease recurrence with hormonal therapy alone. These patients will only receive hormonal therapy. About 25 percent of patients are estimated to have a Recurrence Score result in this range.
- If the Recurrence Score result is 26 or higher, the risk of recurrence is about 30 percent with hormonal therapy alone and may be reduced to about 10 percent with the addition of chemotherapy. These patients will receive chemotherapy and hormonal therapy. About 30 percent of patients are estimated to have a Recurrence Score result in this range.
- If the Recurrence Score result is 11 to 25, the risk of recurrence is about 7 percent to 16 percent with hormonal therapy alone. Patients who have a Recurrence Score in this range will be randomly assigned to receive chemotherapy plus hormonal therapy (the standard treatment arm) versus hormonal therapy alone (the experimental treatment arm). About 44 percent of patients are estimated to have a Recurrence Score result in this range.
6. What is randomization and why is it necessary?
Randomization is like flipping a coin. The treatment will be assigned by chance. This procedure is commonly used in clinical trials when new treatment approaches are being tested, and when there is uncertainty about the best treatment approach. Patients with a Recurrence Score result of 11 to 25 will be randomly assigned to receive, or not to receive, chemotherapy because the benefit of chemotherapy is uncertain in this group, even though chemotherapy would normally be recommended for this group based upon standard characteristics, such as tumor pathology, traditionally used in clinical practice.
7. Why is randomization not being used for all patients participating in this study?
Patients who have a low Recurrence Score result (10 or lower) or high Recurrence Score result (26 or higher) will not be randomized. Patients with a low Recurrence Score result will be assigned to receive hormonal therapy alone, and patients with a high Recurrence Score result will be assigned to receive chemotherapy plus hormonal therapy. Patients in these groups are being directly assigned, rather than randomized, to treatment because researchers already know that chemotherapy is not beneficial or is very unlikely to be beneficial for those who have a low Recurrence Score result and is very likely to be beneficial for those who have a high Recurrence Score result.
8. What treatments will be used in the trial?
All treatments used in this trial, including chemotherapy and hormonal therapy, are commercially available and are not considered experimental. The choice of exactly what type of chemotherapy and hormonal therapy will be used will be left to the discretion of the treating physician.
Hormonal therapies in the trial are prescribed based on menopausal status and include tamoxifen and the aromatase inhibitors anastrozole, letrozole and exemestane. Women in the chemotherapy arm of the trial will receive one of several standard combination chemotherapy regimens considered to be the standard care today.
9. What are some of the side effects caused by these medications?
The most common side effects of the standard chemotherapy regimens in the treatment of early-stage breast cancer include nausea, vomiting, hair loss, fatigue, anemia and infection. Side effects of hormonal therapy include hot flashes, osteoporosis and vaginal discharge and/or dryness. If a woman has not entered menopause, some of the treatments may cause premature menopause or sterility.
10. Will insurance cover the cost of the Oncotype DX test used in this trial?
The Oncotype DX test that is being used in this trial is an established diagnostic test in the U.S. that is approved for coverage by the Medicare contractor responsible for processing claims submitted by Genomic Health. The test is commercially available, and the Genomic Health laboratory is certified by federal and state agencies in the U.S. to perform this test.
The cost of the Oncotype DX test will be billed to the patient’s insurance company. Should participants be unsuccessful in receiving reimbursement for all or some of the cost of the Oncotype DX test, the NCI has arranged that the participants will have no financial responsibility for the Oncotype DX test.
11. What treatment would normally be given to someone who is eligible for the trial but does not participate in the trial?
All patients with breast cancer require surgery, or surgery plus radiation therapy. Patients with estrogen-receptor-positive and/or progesterone-receptor-positive early-stage breast cancer receive hormonal therapy for a period of at least five years. There are several types of hormonal therapy, but the treatment usually consists of pills taken once or twice daily. Patients participating in this trial meet standard clinical criteria for administering chemotherapy in addition to hormonal therapy, which would generally be considered part of standard treatment.
12. Who is conducting the trial?
This trial is being conducted by the North American Breast Cancer Intergroup, which includes all of the major National Cancer Institute-funded cooperative groups in the United States and Canada. The trial will be coordinated by the Eastern Cooperative Oncology Group (ECOG), which is one of the major groups participating in the trial. Other participating groups include the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Cancer and Acute Leukemia Group B (CALGB), the Southwest Oncology Group (SWOG), the North Central Cancer Treatment Group (NCCTG), the National Cancer Institute of Canada (NCIC) and the American College of Surgeons Oncology Group (ACOSOG). These groups include networks of researchers, physicians and healthcare professionals at public and private institutions across the United States and Canada. They conduct clinical trials on all types of adult cancers. The groups receive funding from the National Cancer Institute and other sources. The goal of these groups is to control, effectively treat and ultimately cure cancer. These groups provide research results to individuals and the medical community through scientific publications and professional meetings.