Lack of correlation of clinical breast examination with high-risk histopathology. PURPOSE: Routine breast examination frequently finds differences in palpable density and palpable nodularity, but it is not known if these differences correlate with the presence of high-risk histopathology. PATIENTS AND METHODS: To test for a relationship between clinical breast examination and histopathology, we devised separate, 4-point scales of clinical density and nodularity and validated these scales by repeat examinations 4 or more months apart in 199 separate breasts (the scale was the same or within 1 point on repeat examination 87% of the time for density and 90% for nodularity). We then used these two clinical scales to compare density and nodularity to histopathology of breast tissue at the margins of segmental resections in 60 women undergoing breast-conserving treatment of primary breast cancer. In cases such as these, a large sample of "normal" tissue is intentionally removed when the wide excision is done to obtain negative margins. Histopathology at the margins was graded according to the consensus panel of the American College of Pathology; as might be expected in women with previous cancer, some higher-risk histopathology was found in 37% of cases. A relationship was sought using Spearman's rank correlation coefficient. RESULTS: Neither clinical breast density (rho = 0.16) nor clinical breast nodularity (rho = 0.01) related to the presence of high-risk histopathology in the underlying tissue. Interestingly, breast nodularity increased with age (rho = 0.28), and clinical density and nodularity were inversely related (rho = -0.28). CONCLUSION: We conclude that neither clinical breast density nor nodularity correlates with histopathology and that it is unlikely that a larger study would find a clinically useful correlation. Therefore, a clinical examination should not be used to decide that high-risk histopathology is likely to be present in an individual woman's breast. 