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The TAILORx Breast Cancer Trial TAILORx: Testing Personalized Treatment for Breast Cancer
The Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, will 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.
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. TAILORx is one of the first trials to examine a methodology for personalizing cancer treatment.
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 that has not yet spread to the lymph nodes are eligible for the study. (See a summary of the TAILORx protocol 3, which includes contact information for those sites currently enrolling participants.)
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 4). 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.
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Personalized Treatment Trial for Breast Cancer Launched 5
The Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, was launched on May 23, 2006, 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. Questions and Answers 6, TAILORx en Español 7
Tailored Treatment for Breast Cancer 8
In this trial, doctors will use a test called the Oncotype DX Breast Cancer Assay, which measures the activity of a set of genes in breast tumor tissue, to determine which women will receive adjuvant chemotherapy in addition to hormone therapy.
Cancer Diagnostics: Informing the Development of Tailored Cancer Therapy 9
An article about tailored cancer therapy and molecular diagnostics in the May 23, 2006, issue of Benchmarks, an online feature of the National Cancer Institute's Office of Media Relations.
Targeted Cancer Therapies 10
This NCI fact sheet describes targeted cancer therapies, which are drugs that block the growth and spread of cancer by interfering with specific molecules involved in carcinogenesis (the process by which normal cells are transformed into cancer cells) and tumor growth.
Molecular Targets in Cancer Therapy 11
The past two decades of biomedical research have yielded an enormous amount of information about the molecular events that take place during the development of cancer.
Program for the Assessment of Clinical Cancer Tests (PACCT) 12
The PACCT has been developed to ensure that development of the next generation of laboratory tests is efficient and effective.
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