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Background   BRCA1  promoter methylation has been detected in DNA from peripheral blood cells of both breast cancer patients and cancer-free females. However, the pathological significance of this epigenetic change in white blood cells (WBC) remains an open question. In this study, we hypothesized that if constitutional  BRCA1  methylation reflects an elevated risk for developing breast cancer (BC), WBC that harbor methylated  BRCA1  in both cancer-free females and BC patients should exhibit similar molecular changes.    Methods   BRCA1  promoter methylation was examined by methylation-specific PCR in WBC from 155 breast cancer patients and 143 cancer-free females. The Human Breast Cancer EpiTect Methyl II Signature PCR Array and The Human Breast Cancer RT 2  Profiler™ PCR Array were used to study the methylation status and the expression profile of several breast cancer-related genes, respectively. In addition, we used label-free MS-based technique to study protein expression in plasma.    Results  We have shown that 14.2% of BC patients and 9.1% of cancer-free females (carriers) harbored methylated  BRCA1  promoter in their WBC. Interestingly, 66.7% of patients harbored methylated  BRCA1  promoter in both WBC and tumors. Importantly, we have shown the presence of epigenetic changes in 9 other BC-related genes in WBC of both patients and carriers. Additionally,  BRCA1  and 15 other important cancer –related genes were found to be differentially expressed in WBC from patients and carriers as compared to controls. Furthermore, we have shown that the carriers exhibited a unique plasma protein pattern different from those of BC patients and controls, with 10 proteins similarly differentially expressed in patients and carriers as compared to controls.    Conclusions  The present results suggest the presence of a strong link between aberrant methylation of the  BRCA1  promoter in WBC and breast cancer –related molecular changes, which indicate the potential predisposition of the carriers for developing breast cancer. This informs the potential use of the aberrant methylation of  BRCA1  promoter in WBC as a powerful non-invasive molecular marker for detecting predisposed individuals at a very early age.

The molecular significance of methylated BRCA1 promoter in white blood cells of cancer-free females