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Notes: Abstract Background: In the early 1980s breast preservation was a rarely applied therapeutic modality in the primary treatment of breast cancer in the Federal Republic of Germany. Reports coming from retrospective studies as well as preliminary results from randomized trials made it desirable to introduce breast preservation in the form of a controlled clinical trial. Study design: In stage pT1 N0 M0 breast cancer, mastectomy as the standard treatment was to be compared with radiotherapy of the remaining breast tissue. The study design originally planned as a randomized trial had to be changed into a prospective observation study due to the low randomization rate. Univariate analysis of prognostic variables was the first step to a valid treatment comparison. Those factors determined as being significant were included together with the treatment effects in a multivariate analysis. A high therapeutic standard was guaranteed by quality control. Results: 1036 out of 1119 recruited patients are evaluable. After a median follow-up of 48 months the following preliminary results can be reported. With the exception of death without recurrence from breast cancer, the 143 events are evenly distributed among the two treatment groups. Locoregional recurrence of the whole patient population was 5%. Out of all prognostic factors examined only tumor size and grading are significant in regard to recurrent disease. Recurrence-free survival decreased in cases with ‘uncertain’ tumor margins, whereas the width of the margin had no influence on recurrent disease. There was no significant difference in quality of life between the two treatment groups. Conclusions: The four-year results of this study are in accordance with those of other breast preservation trials: There is no significant difference between the two treatment groups in the occurrence of locoregional failure. Incomplete tumorectomy has a negative influence on recurrence. Quality of life seems more dependent on the acceptance of the therapy by the patient than on the therapeutic modality itself. Breast preservation can also be performed appropriately in smaller institutions if the therapeutic standard is guaranteed by quality control.