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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10CA020321-13
Application #
3556512
Study Section
(SRC)
Project Start
1977-03-01
Project End
1991-01-31
Budget Start
1989-02-01
Budget End
1990-01-31
Support Year
13
Fiscal Year
1989
Total Cost
Indirect Cost
Name
Royal Victoria Hospital
Department
Type
DUNS #
City
Montreal
State
PQ
Country
Canada
Zip Code