This application is seeking funding to establish the NSABP Operations Center and to continue the efforts initiated during the previous grant periods that will enable the step-wise and methodic evolution of therapeutic regimens for breast and colorectal cancers. Since 1971, the NSABP has been continuously funded by the National Cancer Institute and more than 40,000 patients have been entered into the group's clinical trials. The principal objective of the NSABP is to improve survival and disease-free survival in women with breast cancer, and men and women with colon and rectal cancer.
Specific aims for the work to be carried out during the period of this cooperative agreement include: 1. The completion of accrual to on going NSABP therapy trials. Five NSABP Phase III studies are currently open for patient accrual: B-21, B-23, B-26, B-28 and R-03. 2. The continuation of patient follow-up in selected NSABP trials that have completed patient accrual. 3. The implementation of new phase III trials in order to address the principal objective of the group. 4. The continuation of the restructuring process of the NSABP in compliance with the guidelines of the RFA: CA-95-011. 5. The participation of the NSABP in selected Intergroup trials. 6. The establishment of scientific consortia with basic scientists that will foster and enhance translational research studies. It is the intention of the NSABP to base future studies on strategies evolved from the laboratory and to make the NSABP clinical resources available for the evaluation of research hypotheses. 7. The expansion of the current NSABP tumor bank and the development of an NSABP serum bank. 8. The support and assistance of the Biostatistical Center in performing quality control and study monitoring. 9. In conjunction with the Biostatistical Center, the submission of results of NSABP trials to peer-reviewed journals in a timely and responsible manner. 10. The conduct of periodic review in order to assess the performance and membership status of each main member and affiliate; this review will examine scientific contribution, patient accrual and follow-up, data accuracy and timeliness, protocol compliance, audit results and adherence to regulatory requirements. 11. The integration of representatives of the patient advocacy community into appropriate NSABP committees and activities. 12. The enhancement of participation of women, minorities and geriatric patients in NSABP clinical trials.
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