BIOMARKERS, BREAST DENSITY, AND RISK REDUCTION PERSPECTIVES

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to evaluate the effect on breast density, on perspectives about risk reduction options, and on quality of life of 6-10 months of treatment with a nasal spray containing the investigational drug deslorelin, plus partial replacement of estrogen and testosterone with a second nasal spray and of progesterone given as a pill. The effects on breast tissue will be evaluated through imaging studies and laboratory studies of biopsy samples. Reducing the density of breast tissue could make mammograms easier to read, which could allow earlier recognition of any abnormality of the breast tissue. There is evidence that breast density decreases when exposure to steroid hormones is decreased. Some examples of this are a decrease in breast density at menopause, when ovaries are removed, or when a drug is taken that reduces hormone production. The drug deslorelin is known to suppress the production of progesterone, estrogen, and testosterone by the ovaries. Partial replacement of estrogen and testosterone in this study are given with deslorelin to reduce the likelihood of symptoms such as hot flashes, insomnia, vaginal dryness and mood swings that may be associated with the use of deslorelin alone. A previous study of this regimen has demonstrated that breast density decreases while taking the drug, making mammograms easier to read. The low doses of estrogen and testosterone that will be added back in this study have also been shown to maintain bone density and quality of life. In addition, most women resume normal menses within 36-60 days after finishing the treatment. Mammograms are the standard imaging test used in early breast cancer detection. Because mammograms may be difficult to read because of dense breast tissue, alternative methods of breast imaging have been used including magnetic resonance imaging. MRI uses radiowaves delivered by a magnet to obtain high-quality cross-sectional images of a patient's body. RODEO MRI sequence has the ability to alter the imaging of fat tissue in the breast to allow improved images. MRI has been shown to be useful in finding lesions that may not be seen well on mammography. A questionnaire has been developed that asks about the physical and emotional well being of women receiving hormone suppression treatment. By obtaining this information, researchers may be able to measure the impact of the study treatment on quality of life.