Background: Accurate assessment of breast-cancer-risk will benefit most women. Analysis of promoter hypermethylation in exfoliated epithelial cells in breast milk provides an ideal opportunity to assess breast-cancer-risk, as our preliminary data suggest that we can detect a cancer methylation phenotype in the milk of women at high risk. We propose to examine breast milk samples from lactating women who are scheduled for a breast biopsy. About 10% of such women will have breast cancer; the remaining 90% will have benign lesions. Methylation analysis of epithelial cells in milk samples from each breast, will allow us to compare the promoter methylation in the diseased and the non-diseased breast of each woman. In addition, using the pathology reports and questionnaire data, we can compare methylation patterns between women with cancer and those without malignancy. Importantly, since 90% of our samples will come from women with benign disease, we can examine the relationship between promoter methylation patterns and breast-cancer-risk as defined by type of lesion, family history, and other risk factors.
Objective/Hypothesis: Our goal is to develop a noninvasive molecular tool that can be used to accurately assess an individual’s risk of developing breast cancer. Our hypothesis is that epithelial cells isolated from breast milk can serve as a sensitive and reliable tool for assessing breast-cancer-risk.
This study at the University of Massachusetts, Amherst, is analyzing epigenetic differences found in breast milk donated by women who have a breast biopsy that is either normal, abnormal, or shows signs of cancer. Learning more about these epigenetic differences may eventually help researchers develop a way to provide women with information about their breast cancer risk. The researchers originally wanted to enroll up to 250 volunteers from anywhere in the US. The Call to Action for this study was sent to Army of Women (AOW) members on Nov. 17, 2008. The research team expanded their study in 2011 to increase participant diversity, specifically recruiting racial/ethnic minorities. The researchers closed enrollment on Nov. 2, 2014. In total, the AOW provided them with a diverse group of 394 women who were interested in enrolling in the study.
The MILK Study