EUCTR2007-007740-10-IT进行中（未招募）不适用
Randomized placebo-controlled phase III trial of low-dose tamoxifen women whit IntraEphitelial Neoplasia(IEN) - TAM-01
AZIENDA OSPEDALIERA OSPEDALI GALLIERA0 个研究点开始时间: 2008年7月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Women of age < 75 years - Women operated on for ER-positive lobular (LIN1, 2 and 3) or ductal (DIN 1-3, excluded DIN 1a) intraepithelial neoplasia. Both incident (diagnosis within 12 months) and prevalent cases (diagnosis between previous 12 and 60 months) will be included, upon stratification. - Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Any type of malignancy, with the exclusion of CIN and non-melanoma skin cancer; - Active proliferative disorders of the endometrium such as atypical hyperplasia, history of active endometriosis, unresected polyps; - Alterations of metabolic, liver, renal and cardiac grade 2 function (NCI criteria grade 2 or higher); - Any type of retinal disorders or severe cataract; - Presence of significant risk factors for venous events, including immobilization within the last 3 months for longer than 2 weeks following surgery or trauma, deep venous thrombophlebitis or other significant VTE (pulmonary embolism, stroke, etc.); - Use of tamoxifen, raloxifene or other SERMs within the last 4 weeks; - Anticoagulant therapy in progress (heparin or dicoumarol); - Active infections; - Severe psychiatric disorders or inability to comply to the protocol procedures;
研究者
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