A Large Multi-Center Trial Attempting Individualized Therapy of Early Stage Breast Cancer Based on Predicted Risk of Recurrence

AbstractResearchers at the University of Michigan Comprehensive Cancer Center will help lead a new study designed to examine whether women with early-stage lymph node-negative breast cancer can be assigned to individualized treatment plans based on certain genes that may predict whether their cancer will return.The study, called the Trial Assigning Individualized Options for Treatment (Rx), or TAILORx, is sponsored by the National Cancer Institute, part of the National Institutes of Health, and will be conducted by all of the NCI-sponsored clinical trials groups* that perform breast cancer research studies. Daniel Hayes, M.D., clinical director of the breast oncology program at the U-M Comprehensive Center Center, will lead the portion of the trial conducted by the Southwest Oncology Group, one of the largest cancer clinical trials cooperative groups in the United States.Up to 90% of women with early-stage breast cancer are advised to receive chemotherapy in addition to radiation and hormone therapy, yet research has not demonstrated that chemotherapy benefits all of them. TAILORx seeks to identify women who would not benefit from chemotherapy in order to spare them unnecessary treatment. The study will enroll more than 10,000 women from 900 sites in the United States and Canada. Women recently diagnosed with estrogen-receptor positive, Her2/neu (a gene that carries poorer prognosis for patients) negative breast cancer, which has not yet spread to the lymphnodes, are eligible for the study.Using Oncotype DX™, a modern 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 will determine the most effective cancer treatment, with the fewest side effects, for women with early-stage breast cancer. TAILORx is the firsttrial 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. “This is a very exciting trial,” said Dr. Hayes, who also is professor of internal medicine at the U-M Medical School. “It is reassuring that so many newly diagnosed breast cancer patients have a high chance of being cured by hormone therapy alone. Unfortunately, there are some women whose cancer will recur. The TAILORx trial will help us identify those women so that we canoffer them chemotherapy to increase their chance of survival. This way, we can use chemotherapy only when it is necessary and spare the vast majority of the women the side effects associated with it. After many years of translational research, we are finally beginning to perform prospective trials to test the relative clinical utility of a new, molecular-based diagnostics. The TAILORxtrial will be a flagship study of this type.” Dr. Hayes is also vice chair of the Southwest Oncology Group’s Translational Medicine Committee and chair of the Translational Medicine Breast Subcommittee.Breast cancer is the most frequently diagnosed cancer in women, with an estimated 212,920 new cases of invasive breast cancer in the U.S. in 2006. Nearly half of these women will have estrogen-positive, lymphnode-negative breast cancer. For 80 to 85 percent of those women, the current standard practice is surgical excision followed by radiation and hormone therapy.Chemotherapy is also recommended for most women but the proportion of women who actually benefit from chemotherapy is fairly small. Oncotype DX™ identifies which genes, out of a total of 21, are turned on or off in a woman’s tumor. 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™ gene analysis, a score from 0 to 100 is generated. The higher the score, the greater a woman’s chance of having a recurrence when treated with hormonal therapy alone. Based on their recurrence score, women will be assigned to three differenttreatment groups in the TAILORx study:* Women with a recurrence score of more than 25 will receive chemotherapy plus hormonal therapy (the standard of care).* Women with a recurrence score of less 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 will evaluate the effect of chemotherapy for those with a recurrence score of 11 to 25, as previous studies have already confirmed the benefit of chemotherapy for those in the high recurrence score ranges and the lack of benefit for those in the low recurrence score ranges.An additional goal of this clinical study is to create a tissue and specimen bank for patients enrolled in the trial. Tissue collected in this trial will be stored for use in future clinical studies to evaluate, and potentially refine, diagnostic tests for treatment decisions to an even greater degree than in TAILORx.“This new approach is a big step toward personalized medicine,” said Laurence H. Baker, D.O., chair of the Southwest Oncology Group and professor of internal medicine and pharmacology at the University of Michigan. “Through TAILORx, we hope to learn how we can more effectively use cutting-edge diagnostic tests to improve patients’ quality of life while they receive the most effective treatment.” Women in the study will have a physical exam performed by their doctor every six months for the first five years, then once a year after that. An annual mammogram will check for signs of recurrence.For eligibility and registration information on TAILORx, go to http://www.ctsu.org/ and enter 'TAILORx' in the search box.About the Southwest Oncology GroupThe Southwest Oncology Group is one of the largest cancer clinical trials cooperative research groups in the United States. The Group is a network of more than 5,000 physician-researchers located at nearly 550 institutions. In addition to their regular medical practices, Group investigators work together on clinical trials funded by the National Cancer Institute, part of theNational Institutes of Health, to prevent and treat cancer in adults. Among the Group’s institutions are 17 of the NCI’s 61 designated cancer centers. The Group enrolls nearly 7,200 patients each year and has about 120 clinical trials underway at any given time. The Southwest Oncology Group Headquarters Office is at the University of Michigan in Ann Arbor, Mich., the Operations Office is in San Antonio, Texas, and the Statistical Center is in Seattle, Wash.*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).

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