A total of 34 cases of infiltrating ductal carcinoma of the breast, not otherwise specified (NOS), were selected, based on the clinical stage of the disease (17 cases stage I and 17 cases stage II). The histologic grade and the DNA content of each tumor were evaluated. Each specimen was analyzed and blinded cytogenetically for the frequency of chromosome 8 copy number using fluorescence in situ hybridization (FISH). Among the informative samples, 16 cases were disomic (47%) and 18 cases (53%) were trisomic. Of the 16 disomic tumors, 13 cases (82%) were classified clinically as stage I disease and 3 cases (19%) were stage II disease. Of the 18 trisomic tumors, 4 cases (22%) were stage I, and 14 cases (78%) were stage II. Microscopically, all trisomic tumors were of high histologic grade and aneuploid when analyzed by flow cytometry. Mie inferred from these data that a subset of infiltrating ductal carcinomas (NOS) is characterized by chromosome 8 trisomy. This chromosomal abnormality correlates well with other markers that predicate aggressive biological behavior of the tumor. While this observation needs to be further extended, the data suggest that chromosome 8 copy number may be used as a possible marker to identify a subgroup of patients with infiltrating ductal carcinoma associated with a poor prognosis. (C) Elsevier Science Inc., 1997.