CLINICAL TRIAL: BIOMARKERS, BREAST DENSITY, AND RISK REDUCTION PERSPECTIVES

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究的目的是评估在6-10个月的治疗中，使用含有研究药物地洛瑞林的鼻喷剂，加上用第二次鼻喷剂部分替代雌激素和睾酮，以及以黄体酮的形式给予黄体酮，对乳房密度、降低风险选择的前景以及对生活质量的影响。对乳房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。降低乳房组织的密度可以使乳房X光照片更容易阅读，这可以更早地识别乳房组织的任何异常。有证据表明，当减少接触类固醇激素时，乳房密度会降低。这方面的一些例子包括更年期、摘除卵巢或服用减少荷尔蒙产生的药物时乳房密度下降。众所周知，药物地洛瑞林可以抑制卵巢产生孕激素、雌激素和睾酮。在这项研究中，雌激素和睾丸素的部分替代与地洛瑞林一起使用，以减少可能与单独使用地洛瑞林有关的潮热、失眠、阴道干燥和情绪波动等症状的可能性。之前对这种疗法的一项研究表明，服用该药物时，乳房密度会下降，使乳房X光照片更容易阅读。这项研究中将补充的低剂量雌激素和睾丸素也被证明可以保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测试。由于乳腺组织致密，乳房X光照片可能难以阅读，因此使用了包括磁共振成像在内的其他乳房成像方法。核磁共振成像使用由磁铁发射的无线电波来获得患者身体的高质量横断面图像。Rodeo MRI序列能够改变乳房脂肪组织的成像，以改善图像。核磁共振已被证明在发现乳房X光检查中可能看不清楚的病变方面很有用。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.