CLINICAL TRIAL TO DETERMINE WORTH OF TAMOXIFEN FOR BREAST CANCER PREVENTION

确定他莫昔芬预防乳腺癌价值的临床试验

• 批准号: 6114262
• 负责人: KATHY J HELZLSOUER
• 金额: $ 2.06万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6114262
• 关键词: breast neoplasms; cancer prevention; cancer risk; chemoprevention; clinical research; clinical trials; drug administration rate /duration; drug screening /evaluation; female; human subject; human therapy evaluation; longitudinal human study; tamoxifen; women's health

The study is an NSABP sponsored multi-center randomized trial to determine if tamoxifen in a daily dose of 20 mg reduces the risk of developing breast cancer compared to placebo. Women eligible for the study include women over the age of 60 or women 35 to 59 who have an estimated risk of developing breast cancer similar to that of a 60 year old woman. Participants take study pills for 5 years. We stopped enrolling women to the study in 1993; NSABP closed the study to enrollment in 1997. Over 50 women have been screened and 5 have been randomized. The majority of women refuse participation because of either potential side effects of tamoxifen or the wish to continue estrogen replacement therapy. One woman is now off the study after developing uterine cancer. Another woman went off the study because of side effects of the study pills. A third woman completed 5 years of taking study pills in November of 1997, and the last two women still taking study pills will stop taking the pills in February and July of 1998. Sally Brown, R.N., and Sue Markus, R.N., of the office of Dr. E. George Elias, will continue to collect reports of examinations, medical follow-up and history from all five women, at least through 1999. NSABP expects that enough information will be available to determine the preventive effects of Tamoxifen in 1999 or 2000.

这项研究是由NSABP赞助的多中心随机试验 确定每天服用20毫克的他莫昔芬是否可以降低糖尿病的风险 与安慰剂相比，乳腺癌的发病率更高。符合资格的妇女 研究对象包括60岁以上的女性或35至59岁的女性 估计患乳腺癌的风险与60岁的风险相似 老妇人。参与者服用5年的学习药片。我们停了下来 1993年招募女性参加这项研究；NSABP结束了这项研究 1997年招生。 超过50名妇女接受了筛查，5名妇女被随机分配。这个 大多数女性拒绝参与，因为任何一方都有可能 他莫昔芬的疗效或希望继续雌激素替代 心理治疗。一名妇女因患上子宫症而退出研究 癌症。另一名女性因该药的副作用而退出研究。 学习药片。第三名妇女完成了5年的服用学习药片 1997年11月，最后两名女性仍在服用学习药片 将于1998年2月和7月停止服药。萨莉·布朗 和E.George Elias博士办公室的Sue Markus，R.N.将 继续收集检查报告、医疗跟进报告和 所有五位女性的历史，至少一直持续到1999年。NSABP预计 将有足够的信息来确定预防措施 他莫昔芬在1999年和2000年的应用效果。