145 women (22.2%) out of 652 patients with primary breast cancer, who were operated on between January 1980 and September 1988, developed tumour relapse until May 1990. The aim of our retrospective analysis in these 145 patients with local and/or distant tumour relapse was to evaluate the prognostic importance for further survival of the following factors: menopausal status, stage of disease, number of involved axillary lymph nodes, tumour grading, ER and PgR content, postoperative irradiation, adjuvant treatment, localisation of tumor relapse and relapse-free interval. Multivariate stepwise regression analysis of all these factors identified the number of positive axillary lymph nodes (0-3 versus 4+) with a relative risk (RR) of 2.49 and localisation of tumour relapse (local versus visceral metastasis RR = 2.08 and local versus bone metastases RR = 2.08) as the only two significant prognostic factors for further survival. Therefore, these two factors should be stratification criterias for prospectively randomized phase III studies in patients with tumour relapse after primary breast cancer.