This research proposal is a part of the Primary Breast Cancer Therapy Group - NSABP. The main objective of the NSABP is to improve disease-free survival and overall survival in patients with primary operable breast and colo-rectal cancer (See the NSABP Headquarters Grant application for protocol rationale and overall scientific achievements). Michigan State University has been a member of NSABP since 1976. During the first ten years, the satellites, campuses in the state of Michigan, formed a strong consortium with the nucleus at the main campus. At the present time, we are treating and following 953 patients on long-term NSABP adjuvant protocols. We expect to increase our accrual to 160 (30%) patients per year which will increase substantially the number of follow-up patients during the next five years. Five new oncologists trained in clinical trials joined our community campuses. They will contribute to the increase of the accrual. Our outreach program has been a major contributor to NSABP clinical trials during the last years. Besides our efforts to accrue patients to NSABP protocols, our members participated actively in the scientific activities of the group as chair of the Committee of Biologics in Diagnosis and Treatment of Breast Cancer, Colon Committee, and organized and planned group scientific programs. The PI participates actively in the design of the pilot studies. Having a well developed laboratory equipped with HPLC, GLC and Mass Spectroscopy apparatuses, our institution will offer to the group additional studies related to drug and hormone metabolites. We have and will continue to participate actively in the group meetings. The PI has been on the executive committee of the group for the last five years and one of the nurses on the Nursing Committee for the last six years. We are contributing to the Audit Program of the group with two nurses assigned to auditing teams. Three physicians have participated in recent publications of manuscripts and abstracts presented to ASCO meetings. We intend to increase this activity. The PI has actively participated in numerous NCI site visits and peer review committees. Our institution has a special program to foster and monitor accrual of ethnic minorities to NSABP trials. We have a unique organization for accrual and execution of NSABP trials based on academic community consortium (community campuses) and the PI assumes responsibility for all activities related to the group efforts.
