UTERINE SURVEILLANCE & MANAGEMENT DURING TAMOXIFEN THERA

描述：他莫昔芬对乳腺癌的治疗有益，但 与子宫癌风险显著增加相关。 拥有超过 全世界有100万妇女服用他莫昔芬，子宫监测已成为 一个重大的临床问题 目前，关于价值的数据很少。 常规子宫筛查检测癌前子宫病变 无症状女性或子宫异常女性的诊断性检测 流血了 早期发现和治疗癌前病变可预防 子宫癌，但筛查和治疗方案还没有 确立了习 我们建议进行一项横断面研究，收集以下方面的试点数据： 子宫内膜病理的患病率和一项简短的前瞻性队列研究， 确定100例癌前子宫病变治疗的反应 患有乳腺癌并正在服用他莫昔芬的子宫妇女。 我们 还将获得有关筛查和诊断准确性的试点数据， 阴道内超声（EVS）和磁共振成像检测 (MRI)检测子宫异常病变 妇女将从 加州大学旧金山分校/锡安山乳房护理中心和加州大学旧金山分校医学肿瘤诊所 目前有175名接受他莫昔芬治疗的妇女。 所有女性都在 他莫昔芬至少一年将被要求参加这项研究 做EMB EVS和MRI 如果发现子宫癌前病变， 女性可以1）继续他莫昔芬，2）停止他莫昔芬，3）继续 他莫昔芬并添加一种曲马多菌素，4）停止他莫昔芬并添加一种曲马多菌素， 或5）子宫切除术。 治疗的选择将留给 妇女和她的医生，并将取决于她的估计效益， 他莫昔芬和与她特定的子宫内膜异常相关的风险。 将在3个月内重复EMB、EVS和MRI，以评价治疗 反应 这项初步研究数据将使我们能够评估临床 癌前子宫病理学的问题，并将提供初步数据 EVS和MRI筛查和诊断的准确性，使用 子宫内膜活检（EMB）作为金标准，在女性乳腺癌 服用他莫昔芬 它还将提供对以下方面的有效性的估计： 癌前子宫病变的治疗。 这些试点数据将不会 提供足够的统计能力来评估我们的研究问题，但 将允许计划一项关于子宫内膜异位症发生率的纵向研究 病理学、筛查试验的准确性和对治疗的反应。

DESCRIPTION: Tamoxifen is beneficial for treatment of breast cancer, but is associated with a marked increased risk of uterine cancer. With over 1,000,000 women worldwide taking tamoxifen, uterine surveillance has become a major clinical issue. There are currently few data on the value of routine uterine screening to detect premalignant uterine pathology in asymptomatic women or diagnostic testing in women with abnormal uterine bleeding. Early detection and treatment of premalignant disease may prevent uterine cancer, but screening and treatment protocols have not been established. We propose a cross-sectional study to collect pilot data on prevalence of endometrial pathology and a brief prospective cohort study to determine response to treatment of premalignant uterine pathology in 100 women with a uterus who have breast cancer and are taking tamoxifen. We will also obtain pilot data on the accuracy of screening and diagnostic testing with endovaginal ultrasound (EVS) and magnetic resonance imaging (MRI) to detect abnormal uterine pathology. Women will be recruited from the UCSF/Mount Zion Breast Care Center and the UCSF Medical Oncology Clinic which currently care for 175 women receiving tamoxifen. All women on tamoxifen for at least one year will be asked to participate in this study and undergo EMB, EVS, and MRI. If premalignant uterine pathology is found, women may 1) continue tamoxifen, 2) discontinue tamoxifen, 3) continue tamoxifen and add a progestin, 4) discontinue tamoxifen and add a progestin, or 5) undergo hysterectomy. The choice of treatment will be left to the woman and her physicians and will be depend on her estimated benefit of tamoxifen and the risk associated with her specific endometrial abnormality. The EMB, EVS, and MRI will be repeated in 3 months to evaluate treatment response. This pilot study data will allow us to assess the magnitude of the clinical problem of premalignant uterine pathology and will provide preliminary data on the accuracy of EVS and MRI for screening and diagnosis, using endometrial biopsy (EMB) as the gold standard, in women with breast cancer taking tamoxifen. It will also provide estimates of the effectiveness of treatments for premalignant uterine pathology. These pilot data will not provide adequate statistical power to evaluate our research questions, but will allow planning of a longitudinal study of incidence of uterine pathology, accuracy of screening tests, and response to treatment.