PRIMARY BREAST CANCER THERAPY GROUP

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As participating institution in the primary breast cancer therapy group (NSABP), we have contributed data from patients entering various protocols, and will continue to contribute data to protocols B-06, 11, 12, 13, 14, C-01 and R-01. The present application seeks funding: (a) to permit continued patient accrual in on-going protocols; (b) to participate in the NSABP activities relating to evaluation and execution of the present trials, design of new protocols, planning for the future, education for increase of patient accrual and cooperation with the headquarters; (c) participation in clinical research accepted by NSABP and particularly clinical investigation related to the effect of adjuvant treatment on our own patients; (4) investigating factors that affect compliance with therapeutic regimen. Though follow-up of all patients on various protocols will be an essential activity as well. Protocol B-06 is a trial to compare the worth of segmental mastectomy with total mastectomy. Our efforts will be directed toward those community hospitals and oncology teams which have not contributed patients to this very important study. We have made a plan to hold workshops every four months which will introduce the community surgeons to the required techniques. Protocols B-11 and 12 evaluate patients with breast cancer Stage II using more aggressive treatment. In this trial we are performing special evaluations of the patients receiving Adriamycin. A cardiology team will evaluate every patient on this drug before treatment and thereafter at periodic intervals using non-invasive techniques. This is of great importance because of the excellent performance status of our patients which may be altered by unexpected cardiotoxicity. Protocols B-13 and 14 will study patients with Stage I and treatment -vs- no treatment will be tested according to their ER status. We will continue to make a substantial contribution as in the past to the adjuvant protocols for primary colo-rectal carcinoma. Finally, an aim of this protocol is to increased the multidisciplinary approach of our institution in clinical trials, and to involve as many community physicians as possible to enhance patient accrual and to create an environment essential to the gathering of important biological data on breast and bowel cancer.