A. LOCAL THERAPY: N.S.A.B.P. PROTOCOL B-06: As the follow-up study to Protocol B-04, this protocol was designed to determine whether Total Mastectomy (the least traumatizing arm in B-04) is comparable to Segmental Mastecomy plus Breast Irradiation or Segmental Mastectomy alone relative to disease-free interval or survival. All patients will undergo a staging axillary node dissection and those with metastatic nodes will receive two drug adjuvant therapy (L-PAM + 5 FU). B. ADJUVANT THERAPY: N.S.A.B.P. PROTOCOLS B-05, B-07, B-08, and B-09: Have shown in a step-wise prospective randomized fashion that additional drug therapy whether single or combined has significantly prolonged the disease-free interval and survivial in certain subsets of women. Protocol B-09 further indicated that grouping patients by estrogen receptor (ER) protein levels was more scientific that by age or menopausal status. 1. STAGE II BREAST CANCER: A. PROTOCOL B-11 Estrogen Receptor negative patients will be randomized to L-Pam+5FU (the most effective NSABP combination) vs L-PAM+5FU plus Adriamycin (the most effective single drug against breast cancer). B. PROTOCOL B-12: Estrogen Receptor negative patients will be randomized to L-PAM+5Fu+Tamoxifen vs L-PAM+5FU+Tomoxifen plus Adriamycin. 2. STAGE I BREAST CANCER: (Axillary Nodes Negative) A. PROTOCOL B-13: E.R. negative patients will be randomzid to no treatment vs Metrotrexate followed sequentially by 5FU. B. PROTOCOL B-14: Estrogen Receptor positive patients will be radomized to Tamoxifen vs Placebo. C. The basic purpose of these protocols is to improve the disease-free interval and survival of women with breast cancer utilizing a multi-institutional and multidisciplinary approach. D. This institution will continue: 1. Accrual of patients into ongoing trials. 2. Close follow-up of patients already entered into protocols. 3. Collaborative studies with other researchers. 4. Input into new protocols. 5. Initiate new studies as supplement to the above trials.
