The Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, was launched today to examine whether genes that are frequently associated with risk of recurrence for women with early-stage breast cancer can be used to assign patients to the most appropriate and effective treatment. 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.

"This trial is important because it is one of the first to examine a methodology for personalizing cancer treatment," said NIH Director Elias A. Zerhouni, M.D.

The majority of women with early-stage breast cancer are advised to receive chemotherapy in addition to radiation and hormonal therapy, yet research has not demonstrated that chemotherapy benefits all of them equally. TAILORx seeks to incorporate a molecular profiling test (a technique that examines many genes simultaneously) into clinical decision making, and thus spare women unnecessary treatment if chemotherapy is not likely to be of substantial benefit to them. The study will enroll over 10,000 women at 900 sites in the United States and Canada. Women recently diagnosed with estrogen receptor and/or progesterone receptor positive, Her2/neu negative breast cancer, which has not yet spread to the lymph nodes, are eligible for the study. Overexpression of the Her2/neu gene carries poorer prognosis for patients.

TAILORx will determine the most effective current approach to cancer treatment, with the fewest side effects, for women with early-stage breast cancer by using Oncotype DX^TM, a validated diagnostic test developed by Genomic Health, Inc., Redwood City, Calif., in collaboration with the National Surgical Adjuvant Breast and Bowel Project (NSABP), a network of cancer research professionals. TAILORx is the first trial to be launched as part of a new NCI program, the Program for the Assessment of Clinical Cancer Tests (PACCT), which seeks to individualize cancer treatment by using, evaluating and improving the latest diagnostic tests.

Research appearing online today in the Journal of Clinical Oncology** provides strong evidence for the value of using Oncotype DX^TM to help women with this form of breast cancer determine whether they will benefit by adding chemotherapy to hormonal therapy. This study, as well as several other similar studies in recent years, provided the basis for the launch of TAILORx.

Breast cancer is the most frequently diagnosed cancer in women, with an estimated 212,920 new cases of invasive breast cancer expected in the United States in 2006. Over one-half of these women will have estrogen receptor positive, lymph node negative breast cancer. For 80 percent to 85 percent of those women, the current standard treatment practice is surgical excision of the tumor, followed by radiation and hormonal therapy. Chemotherapy is also recommended for most women, but the proportion of women who actually benefit substantially from chemotherapy is fairly small.

"A large number of these women are receiving toxic chemotherapy unnecessarily, and we need a means of identifying them," said Jo Anne Zujewski, M.D., senior investigator in the Clinical Investigation Branch of NCI's Cancer Therapy Evaluation Program. "TAILORx could help change the way we treat breast cancer and improve the quality of patients' lives, helping to better identify women who are likely to benefit from chemotherapy from those who are not."

Oncotype DX^TM measures the levels of expression of 21 genes (whether they are transcribed into messenger RNA) in breast tumors. This assessment can more precisely estimate a person's risk of recurrence than standard characteristics, such as tumor size and grade. Based on the Oncotype DX^TM gene expression analysis, a recurrence score from 0 to 100 is generated; the higher the score, the greater a woman's chance of having a recurrence if treated with hormonal therapy alone.

Women will be studied for 10 years, with an additional follow-up of up to 20 years after initial therapies. Based on their recurrence score, women will be assigned to three different treatment groups in the TAILORx study:

• Women with a recurrence score higher than 25 will receive chemotherapy plus hormonal therapy (the standard of care)
• Women with a recurrence score lower than 11 will receive hormonal therapy alone
• Women with a recurrence score of 11 to 25 will be randomly assigned to receive adjuvant hormonal therapy, with or without chemotherapy.

TAILORx is designed primarily to evaluate the effect of chemotherapy on those with a recurrence score of 11 to 25. Women in this last group will comprise 4,390 women, or about 44 percent of the study population. Because the degree of benefit of chemotherapy for women with recurrence scores between 11 and 25 is uncertain, TAILORx seeks to determine if the Oncotype DX^TM test will be helpful in future treatment planning for this group.

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. It will also be possible for women participating in TAILORx to participate in other NCI-sponsored clinical trials, provided the therapy prescribed in the clinical trial is consistent with their assigned therapy in TAILORx.

Additional goals of this clinical study are to create a tissue and specimen repository for patients enrolled in the trial and to collect follow-up information regarding the health status of those who participate in the study. Tissue collected in this study will be stored for use in future studies to learn more about breast cancer and to evaluate, and potentially refine, diagnostic tests for treatment decisions to an even greater degree than in TAILORx.

"With TAILORx, we are taking a big step toward personalized medicine. By using cutting- edge diagnostic tests, we'll be able to customize an individual's cancer treatment," said Joseph Sparano, M.D., Montefiore Medical Center, Bronx, NY, and Eastern Cooperative Oncology Group protocol chair.

Women in the study will have a physical exam performed by their doctor every three to six months for the first five years, then once a year after that for up to 20 years. An annual mammogram will check for signs of recurrence.

For eligibility and registration information regarding TAILORx, go to http://www.ctsu.org/ and enter "TAILORx" in the search box.

To view the PDQ summary of the TAILORx protocol, including contact information for sites currently enrolling participants, please go to http://www.cancer.gov/clinicaltrials/ECOG-PACCT-1.

*NCI-Sponsored Clinical Trials Groups: Eastern Cooperative Oncology Group (ECOG), North Central Cancer Treatment Group (NCCTG), The Southwest Oncology Group (SWOG), Cancer and Acute Leukemia Group B (CALGB), American College of Surgeons Oncology Group (ACOSOG), National Cancer Institute of Canada Clinical Trials Group (NCIC CTG), and National Surgical Adjuvant Breast and Bowel Project (NSABP).

**Paik S, Tang G, Shak S, Kim C, Baker J, Kim W, Cronin M, Baehner R, Watson D, Bryant J, Costantino JP, Geyer CE, Wickerham DL, and Wolmark N. Gene Expression and Benefit of Chemotherapy in Women with Node Negative, Estrogen Receptor Positive Breast Cancer, JCO, online May 23, 2006.

"Toward Personalized Medicine," a National Cancer Institute-sponsored Science Writers' Seminar to launch TAILORx, will be held on May 23, 2006, on the NIH campus from 10:30 a.m. until 12:45 p.m. To register, please call (301) 496-6641.

To view a Q&A on TAILORx, go to http://www.cancer.gov/newscenter/pressreleases/TAILORxQandA.

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.

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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