The Nation's Investment in Cancer Research
A Plan and Budget Proposal for Fiscal Year 2008
Prepared by the Director, National Cancer Institute as mandated by The National Cancer Act (P.L. 92-218)
Clinical Trials
NCI supports over 1,300 clinical trials a year, assisting more than 200,000 patients. NCI convened the Clinical Trials Working Group (CTWG) to identify ways that NCI's national clinical trial enterprise could be restructured in order to realize the promise of molecular medicine. The goal is to markedly advance clinical practice for cancer in the 21st century. Ultimately, the true value of the CTWG's restructuring plan will be demonstrated by measures of whether clinical trial initiatives better promote the development of new therapies, diagnostic procedures, and biomarkers that enhance the specificity with which cancer treatments are delivered.
A Closer Look — Personalized Treatment Trial for Breast Cancer
A new NCI clinical trial, the Trial Assigning IndividuaLized Options for Treatment (Rx), dubbed TAILORx, is being hailed by leading breast cancer researchers as an important step toward more individualized treatment of cancer based on factors such as the expression (activity) of specific genes within a patient's tumor cells. TAILORx 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.
The trial will use the results of a new test that measures the expression of 21 genes in tumor samples from women with early-stage invasive breast cancer to assign participants to their treatment regimen. The genomic test used in this trial can more precisely estimate a woman's risk of cancer recurrence than standard characteristics that doctors normally use to assess recurrence risk (such as tumor size and grade). The test result is expressed as a "Recurrence Score." The higher the score, the greater the chance of breast cancer recurrence if a woman is treated with hormone therapy alone. The treatment that patients receive in this trial will depend upon the results of the Recurrence Score.
Although about 90 percent of women with early-stage breast cancer are advised to undergo adjuvant chemotherapy, studies have shown that it decreases recurrence risk in only a small percentage of them. TAILORx could change the way breast cancer is treated, helping to more accurately identify women who are likely to benefit from chemotherapy and those who are not.
