This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This study hypothesizes that aromatase inhibitor letrozole, by means of its strong estrogen deprivation, inhibits not only receptor-mediated proliferation but also the formation of genotoxic metabolites, thereby leading to a reduction in the development of subsequent cancers. The investigators postulate that this agent reduces the estrogenic drive to induce proliferation of the breast cancer cells and, by selecting women at high risk, who are more likely to gain benefit, they intend to demonstrate that they can prevent the development of breast cancers. This pilot trial will assess the potential and feasibility for the use of letrozole for the prevention of breast cancer among 20 postmenopausal women at high risk. The enrollment of a participant in this trial will involve the following: 1) informed consent process, 2) risk assessment, 3) risk assessment counseling, and 4) pre-therapy evaluation. The eligible postmenopausal patient will receive letrozole for one year with the primary objective to measure changes in mammographic density related to risk of breast and evaluate potential and feasibility for use of letrozole. Secondary objectives are serial monitoring of early biological indicators implicated in breast carcinogenesis (monitoring for proteolytic components of the extracellular matrix, oxidative metabolism markers, nutritional markers), as well as end-organ effects of estrogen deprivation that may be important general health issues for women undergoing this intervention (gynecologic symptoms, bone density, lipid profile, cognitive function) and quality of life issues.
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