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

临床试验：生物标志物、乳房密度和降低风险的观点

• 批准号: 7716640
• 负责人: JEFFREY N WEITZEL
• 金额: $ 5.29万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-20 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716640
• 关键词: Back; Biological Markers; Biopsy Specimen; Bone Density; Breast; Breast Cancer Early Detection; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Deslorelin; Dose; Dryness; Estrogen Replacements; Estrogens; Exposure to; Fatty acid glycerol esters; Funding; Grant; Hormones; Hot flushes; Image; Institution; Investigational Drugs; Laboratory Study; Lesion; Magnetic Resonance Imaging; Mammary Gland Parenchyma; Mammography; Measures; Menopausal hot flushes; Menopause; Menstrual fluid; Menstruation; Methods; Moods; Nose; Ovary; Patients; Pharmaceutical Preparations; Production; Progesterone; Purpose; Quality of life; Questionnaires; Reading; Research; Research Personnel; Resources; Risk Reduction; Sleeplessness; Source; Standards of Weights and Measures; Symptoms; Testing; Testosterone; Tissues; Treatment Protocols; United States National Institutes of Health; Vagina; Well in self; Woman; breast density; day; density; improved; pill; steroid hormone

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的目的是评估使用含研究药物地洛瑞林的鼻喷雾剂治疗6-10个月对乳腺密度、风险降低方案的前景以及对生活质量的影响，同时使用第二次鼻喷雾剂部分替代雌激素和睾酮，并以药丸形式给予孕酮。将通过成像研究和活检样本的实验室研究评价对乳腺组织的影响。 降低乳房组织的密度可以使乳房X光照片更容易阅读，这可以使乳房组织的任何异常更早地识别。有证据表明，乳腺密度降低时，接触类固醇激素减少。这方面的一些例子是在绝经期乳房密度下降，当卵巢被切除时，或者当服用减少激素产生的药物时。已知药物地洛瑞林可抑制卵巢产生孕酮、雌激素和睾酮。在这项研究中，用地洛瑞林部分替代雌激素和睾酮，以减少可能与单独使用地洛瑞林相关的症状，如潮热、失眠、阴道干燥和情绪波动。以前对这种疗法的研究表明，服用这种药物时乳房密度降低，使乳房X光片更容易阅读。低剂量的雌激素和睾酮将在这项研究中被添加回来，也被证明可以维持骨密度和生活质量。此外，大多数妇女在完成治疗后36-60天内恢复正常月经。乳房X光检查是早期乳腺癌检测中使用的标准成像测试。由于乳腺组织致密，乳房X线照片可能难以阅读，因此已使用替代的乳腺成像方法，包括磁共振成像。MRI使用由磁体传递的无线电波来获得患者身体的高质量横截面图像。牛仔竞技表演MRI序列能够改变乳房脂肪组织的成像，以改善图像。MRI已被证明是有用的，发现病变，可能无法看到很好的乳房摄影。已经制定了一份问卷，询问接受激素抑制治疗的妇女的身体和情绪健康。通过获得这些信息，研究人员可以测量研究治疗对生活质量的影响。