PER-040-03已完成1 期
INTERNATIONAL MULTICENTRIC STUDY OF TAMOXIFEN VS. ANASTROZOL IN WOMEN POST-MENOPAUSICAS WITH CARCINOMA DUCTAL IN SITU IBIS II (DCIS).
ASTRAZENECA - PERU,0 个研究点目标入组 0 人开始时间: 2003年8月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0(—)
入选标准
- •a) All women must be post-menopausal and have between 40 to
- •70 years. The post-menopausal state is defined as 1 or more of
- •the following criteria: Greater than 60 years, bilateral Ortectomy, less than 60 years with uterus and amenorrhea of at least 12 months, less than 60 years without uterus and with FSH> 20 Ul / L.
- •b) CDIS locally resected within the last 6 months.
- •c) Having baseline bone densitometry within the last 2 years will be required in all women. A column radiograph to rule out
- •Frailty fractures will also be required.
排除标准
- •a) Pre-menopausal woman.
- •b) Any previous cancer in the last 5 years (except non-melanoma skin cancer or in situ cancer of the cervix).
- •c) Current treatment with anticoagulants.
- •d) Deep vein thrombosis or previous puimonar embolism.
- •e) Transient ischemic cerebral accident (TIA) or previous cerebrovascular accident.
- •f) Current or previous administration of Tamoxifen or Raloxifene or other SERMs for more than 3 months or participation in IBIS-I.
- •g) Intention to continue with the use of hormone replacement therapy
- •based on estrogens.
- •h) Women who have had a prophylactic mastectomy or are planning to perform this procedure.
- •i) Any woman with post-menopausal bleeding not explained.
研究者
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