BIOMARKERS, BREAST DENSITY, AND RISK REDUCTION PERSPECTIVES

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的目的是评估6-10个月含研究药物地氯瑞林鼻腔喷雾剂治疗对乳腺密度的影响，降低风险的选择，以及生活质量，再加上用第二次鼻腔喷雾剂部分替代雌激素和睾酮，并以药丸形式给予孕酮。对乳腺组织的影响将通过成像研究和活检样本的实验室研究来评估。降低乳腺组织的密度可以使乳房x光照片更容易阅读，从而可以更早地识别乳腺组织的任何异常。有证据表明，当接触类固醇激素减少时，乳房密度会降低。这方面的一些例子是在更年期，当卵巢被切除时，或者当服用减少激素产生的药物时，乳房密度下降。众所周知，地氯瑞林可以抑制卵巢产生黄体酮、雌激素和睾酮。在本研究中，用地氯雷林部分替代雌激素和睾酮，以减少可能与单独使用地氯雷林相关的症状，如潮热、失眠、阴道干燥和情绪波动的可能性。先前的一项研究表明，服用该药后，乳房密度降低，使得乳房x光照片更容易阅读。低剂量的雌激素和睾丸激素在这项研究中也被证明可以维持骨密度和生活质量。此外，大多数女性在完成治疗后36-60天内恢复正常月经。乳房x光检查是用于早期乳腺癌检测的标准成像检查。由于乳房组织致密，乳房x光片可能难以读取，因此使用了其他乳房成像方法，包括磁共振成像。核磁共振成像使用磁铁发出的无线电波来获得病人身体的高质量横截面图像。RODEO MRI序列有能力改变乳房脂肪组织的成像，以改善图像。MRI已被证明对发现乳房x光检查不能很好地看到的病变很有用。已经开发了一份问卷，询问接受激素抑制治疗的妇女的身体和情感健康状况。通过获得这些信息，研究人员可能能够衡量研究治疗对生活质量的影响。

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.