High-Risk Breast Duct Epithelium

Study Summary

Background: * Breast cancer is the most common malignancy in women, occurring in over 230,000 women annually in the United States. * The vast majority of breast cancers originate in the single layer of epithelial cells that line the ductal/lobular system of the breast milk ducts. The premalignant changes which occur in the transformed epithelium are not well understood, however several cytologic or histologic changes have been identified which are associated with an increased risk for breast cancer, including ductal or lobular hyperplasia, hyperplasia with atypia, and lobular or ductal carcinoma in situ. * The identification of cytological or histological abnormalities in breast epithelial cells is an important component of risk assessment. Objective: Primary objectives are: * To determine the incidence and nature of cytologic changes in ductal epithelial cells from the high-risk breast, in specimens collected by breast ductal lavage, and to determine if these cytologic findings are different from those of female normal volunteers not at increased risk for breast cancer. * To characterize by breast duct endoscopy, high risk breast ductal epithelium and architecture, and correlate these findings with the cytologic findings referenced in above bullet. * To determine what is the global gene expression pattern of high risk breast epithelial cells from the high risk breast, and does this differ from that of breast epithelial cells from female normal volunteersnot at increased risk for breast cancer. The gene expression profile will be determined by cDNA microarray and validated by RT-PCR. Eligibility: Eligibility for high risk individuals will include: * Women with a unilateral invasive or noninvasive (DCIS) breast cancer of epithelial origin. * Women without breast cancer, but with a Gail Index greater than 1.67 percent, or a cumulative lifetime risk greater than or equal to double the age- and race-matched general population risk. * Women known to be BRCA1/2 or