Key Points 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 certain women with early-stage breast cancer. (Question 1) The genomic test used in this trial is called Oncotype DX™. This test analyzes the expression pattern of certain genes in breast tumors and can more precisely estimate a woman's risk of cancer recurrence than standard characteristics that doctors normally use to assess recurrence risk (e.g., tumor size, tumor grade, and other characteristics of the tumor). (Question 5) If Oncotype DX™ test yields a recurrence score from 11 to 25, the risk of recurrence is about 7 percent to 16 percent with hormonal therapy alone, following the standard surgery plus radiation. Patients who have a recurrence score in this range would 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 breast cancer patients have a recurrence score in this range. (Question 6)

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 certain women with early-stage breast cancer. Trial results will help individualize treatment for each breast cancer patient in order to achieve improved clinical 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 meet standard clinical criteria and be medically suitable candidates for adjuvant chemotherapy.

3. What does the trial involve?
All patients who agree to participate in the trial will have a molecular test performed on a sample of the tumor that has already been removed. This test does not require an additional biopsy or other procedures. The specimen will be sent to a laboratory for the test to be done. It takes about seven to 10 days from the time a specimen is received at the laboratory for a doctor to get the result of the test. These results will be used to guide therapy.

4. What are the primary objectives of the trial?
The primary objectives of TAILORx are twofold:

• To determine whether adjuvant hormonal therapy with chemotherapy is better than adjuvant hormonal therapy alone in women whose tumors fall in a range where 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. What is the molecular test used in this trial?
The molecular test is called Oncotype DX^TM. It is a test that analyzes the expression pattern of certain genes in breast tumors. The test can more precisely estimate a woman's risk of cancer recurrence than standard characteristics that doctors normally use to assess recurrence risk (e.g., tumor size, tumor grade, and other characteristics of the tumor). The Oncotype DX^TM test that is being used in this trial has been commercially available since 2004. Genomic Health, Inc. (Redwood City, Calif.), the company that developed the test, performs the assay in its own laboratory. It has been performed on tumor specimens from over 10,000 breast cancer patients thus far.

6. How will the Oncotype DX^TM test be used to guide therapy?
The test result is expressed as a "Recurrence Score." 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 results of the Recurrence Score.

• If the Recurrence Score 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 in this range.
• If the Recurrence Score 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 in this range.
• If the Recurrence Score 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 in this range.

7. 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 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.

8. Why is randomization not being used for all patients participating in this study?
Patients who have a low Recurrence Score (10 or lower) or high Recurrence Score (26 or higher) will not be randomized. Patients with a low Recurrence Score will be assigned to receive hormonal therapy alone, and patients with a high Recurrence Score 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, and is very likely to be beneficial for those who have a high Recurrence Score.

9. 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 assigned based on menopausal status and include tamoxifen and the aromatase inhibitors anastrozole, letrozole and exemestane. Women on the chemotherapy arm of the trial will receive one of several standard combination chemotherapy regimens considered to be the best available standard care today.

10. What are some of the side effects caused by these medications?
The most likely side effects of chemotherapy include nausea, vomiting, hair loss, fatigue, anemia, and infection. Some of these side effects can be relieved with medications. 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.

11. Will insurance cover the cost of this trial?
The Oncotype DX^TM test that is being used in this trial is an established diagnostic test in the United States that was recently approved for coverage by Medicare. The test is commercially available, and the Genomic Health laboratory is certified by federal and state agencies in the United States to perform this test.

The cost of the Oncotype DX^TM test will be billed to the patient's insurance company. The treatments and other routine tests done as part of this trial are considered standard care, and also will be billed to the patient's insurance company. Medicare and commercial insurance companies usually cover the routine costs of care required in clinical trials. Coverage may not, however, be the same from plan to plan. Should participants be unsuccessful in receiving reimbursement for all or some of the cost of the Oncotype DX^TM test after appealing to their insurance carrier, they will have no financial responsibility for the Oncotype DX^TM test.

12. What treatment would normally be given to someone who did not participate in the trial?
All patients with breast cancer require surgery, or surgery plus radiation therapy. Patients with ER and /or PR positive early-stage breast cancer receive hormonal therapy given for a period of at least five years. . There are several types of hormonal therapy, but the treatment usually consist of pills taken once or twice daily. In addition, patients participating in this trial meet standard clinical criteria for administering chemotherapy, which would generally be considered part of standard treatment.

13. 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 that are 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.

To view Spanish versions of the TAILORx press release and Q&A, please go to http://www.cancer.gov/newscenter/pressreleases/TAILORxReleaseSpanish.

For a complete set of links and other information related to TAILORx, go to http://www.cancer.gov/clinicaltrials/digestpage/TAILORx.

To view a press release on TAILORx, go to http://www.cancer.gov/newscenter/pressreleases/TAILORxRelease.

For more information about the NCI-sponsored clinical trials groups, please visit:
http://www.ecog.org
http://ncctg.mayo.edu
http://www.swog.org
http://www.calgb.org
http://www.acosog.org
http://www.nsabp.pitt.edu
National Cancer Institute of Canada Clinical Trials Group: www.ctg.queensu.ca

For more information about cancer, please visit the NCI Web site at http://www.cancer.gov, or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).

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