Most breast cancer patients have no known antecedent risk factors. Development of tissue based, molecular markers of breast cancer risk would offer a novel means of individualizing risk assessment and may provide new opportunities for prevention. Activation of the DNA damage response (DDR) is an important cellular mechanism for maintaining genomic integrity. We have recently noted that DNA damage is present in histologically normal mammary epithelial cells adjacent to areas of carcinoma, suggesting that DNA damage may be an early molecular marker of malignant transformation that precedes histologic changes. The objective of this study is to evaluate biomarkers of DDR activation in normal breast tissue as predictors of future development of breast cancer. Our primary hypothesis is that activation of the DDR pathway occurs as an early event in breast tumorigenesis and will be positively associated with invasive breast cancer risk.
A research team at M.D. Anderson Cancer Center in Houston, TX, is investigating whether the amount of DNA damage seen in the cells in normal breast tissue may be an indicator of future breast cancer risk. The researchers recruited women who had a benign breast biopsy and then went on to develop breast cancer (Phase I) and women who had a benign breast biopsy but did NOT go on to develop breast cancer (Phase II). By recruiting women who did develop breast cancer and women who did not, they will be able to look for markers in the breast cells that might be an indicator of breast cancer risk. The researchers wanted to enroll at least 150 women in the study. The Call to Action for Phase I was sent to Army of Women members on August 11, 2010, while the Call to Action for Phase II was sent on January 18, 2012. When the research team closed enrollment on July 10, 2013, the Army of Women had provided them with 338 women who were interested in enrolling in Phase I and 1,333 women who were interested in enrolling in Phase II.