CLINICAL TRIAL: DESLORELIN, ESTRADIOL & TESTOSTERONE IN WOMEN AT HIGH RISK OF BR

临床试验：地洛瑞林、雌二醇

• 批准号: 7716630
• 负责人: JEFFREY N WEITZEL
• 金额: $ 0.24万
• 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/7716630
• 关键词: Benefits and Risks; Bilateral; Breast; Breast Cancer Prevention Trial; Cell Proliferation; Clinical; Clinical Trials; Closure; Computer Retrieval of Information on Scientific Projects Database; Deslorelin; Detection; Dose; Estradiol; Estrogens; Exposure to; Family history of; Funding; Goals; Grant; Health; High Risk Woman; Hormones; Individual; Institution; Malignant Neoplasms; Mammary Gland Parenchyma; Mammographic Density; Mammography; Mastectomy; Menopause; Mutation; National Surgical Adjuvant Breast and Bowel Project; Nose; Ovary; Personal Satisfaction; Pharmaceutical Preparations; Postmenopause; Premenopause; Prevention; Production; Progesterone; Protocols documentation; Purpose; Reading; Research; Research Personnel; Resources; Risk; Screening procedure; Source; Specific qualifier value; Tamoxifen; Testosterone; Treatment Protocols; United States National Institutes of Health; Woman; base; breast density; cancer risk; follow-up; malignant breast neoplasm; prophylactic; 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 goal of this research is to develop a nasal spray which could be used to make mammograms easier to read by reducing breast density which may 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. Whether these effects occur in women at high risk of breast cancer is not known. The ovary normally produces the hormone progesterone as well as estrogen and testosterone. The drug deslorelin is known to suppress the production of these hormones by the ovary. The purpose of this study is to demonstrate that deslorelin will decrease breast density thereby making it easier to interpret mammograms and that deslorelin can be combined with estrogen (estrodial) and testosterone in a nasal spray at doses that are sufficient to maintain a woman in good health and still achieve decreased breast density. We hypothesize that the regimen will result in a reduction in mammographic densities as well as a reduction in breast cell proliferation. If these hypotheses are true, the regimen would not only result in enhanced mammographic screening (and facilitate detection of asymptotic cancers), but could potentially be associated with a reduced risk of breast cancer. Given that many women at highest risk for breast cancer consider prophylactic bilateral mastectomy and an option to decrease breast cancer risk, we feel that the potential risk/benefit ration for this protocol is well justified. Moreover, with the recent closure of the NSABP_P1 Breast Cancer Prevention Trial ('tamoxifen trial'), there are currently no available prevention trials for these women. Moreover, the follow-up NSABP trial (P2), comparing tamoxifen and relaxofene, will be restricted to post-menopausal women. Eligible subjects are pre-menopausal women with an increased risk of breast cancer on the basis of a germline BCRA1 mutation or other specified clinical risk criteria based on family history. The participation of an individual subject is expected to last approximately 14 months.

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。 这项研究的目的是开发一种鼻喷雾剂，通过降低乳房密度，使乳房X线照片更容易阅读，从而可以更早地识别乳房组织的任何异常。 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。 这些影响是否发生在乳腺癌高危女性中尚不清楚。 卵巢正常情况下产生黄体酮、雌激素和睾丸激素。 已知药物地洛瑞林抑制卵巢产生这些激素。 本研究的目的是证明地洛瑞林将降低乳腺密度，从而使其更容易解释乳房X线照片，并且地洛瑞林可以与雌激素（雌二醇）和睾酮在鼻喷雾剂中以足以维持女性健康并仍然实现乳腺密度降低的剂量组合。 我们假设该方案将导致乳腺摄影密度降低以及乳腺细胞增殖减少。 如果这些假设是真的，该方案不仅会增强乳腺X线筛查（并促进渐近癌症的检测），而且可能与乳腺癌风险降低有关。 鉴于许多乳腺癌高危女性考虑预防性双侧乳房切除术，并将其作为降低乳腺癌风险的一种选择，我们认为本方案的潜在风险/获益比是合理的。 此外，随着最近NSABP_P1乳腺癌预防试验（“他莫昔芬试验”）的结束，目前没有针对这些妇女的预防试验。 此外，后续NSABP试验（P2），比较他莫昔芬和relaxofene，将仅限于绝经后妇女。 符合条件的受试者是基于生殖系BCRA 1突变或基于家族史的其他特定临床风险标准，乳腺癌风险增加的绝经前女性。 个体受试者的参与预计持续约14个月。