EUCTR2004-003992-35-SE进行中（未招募）1 期
International Breast Cancer Intervention Study II (DCIS). An international multi-centre trial of tamoxifen v anastrozole in post-menopausal women with ductal carcinoma in situ. - IBIS-II (DCIS)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,000
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
- •The trial is open to post-menopausal women between the ages of 40-70, with ER or PgR+ve DCIS locally excised within the last six months, in which there are tumour free margins of at least 1 mm.
- •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
- •Premenopausal women.
- •Any previous cancer in the past 5 years (except non-melanoma skin cancer or in situ cancer of the cervix).
- •Current treatment with anticoagulants.
- •Previous deep vein thrombosis or pulmonary embolus, previous transient ischaemic attack (TIA) or cerebrovascular accident (CVA, stroke).
- •Current or previous tamoxifen or raloxifene or other SERMs use for more than 6 months in the last 5 years.
- •Women in IBIS-I are eligible if they have been off therapy for at least 5 years.
- •Intention to continue to use oestrogen-based hormone replacement therapy.
- •Women who have either had a prophylactic mastectomy or are planning to have this procedure.
- •Any woman with unexplained post-menopausal bleeding.
- •Women with T-scores of less than minus four or with more than two low trauma vertebral fractures.
- •History of gluten and/or lactose intolerance
研究者
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