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临床试验/ISRCTN91879928
ISRCTN91879928已完成未知

An international multicentre study of tamoxifen versus placebo in women at increased risk of breast cancer

Queen Mary University of London (UK)0 个研究点目标入组 7,000 人开始时间: 2006年6月1日最近更新:
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适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
7,000
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

2002 results in: http://www.ncbi.nlm.nih.gov/pubmed/12243915 2003 results in: https://www.ncbi.nlm.nih.gov/pubmed/14659350 2004 results in: https://www.ncbi.nlm.nih.gov/pubmed/15100340 2006 results in: https://www.ncbi.nlm.nih.gov/pubmed/16921052 2007 results in: https://www.ncbi.nlm.nih.gov/pubmed/17312304 2009 results in: https://www.ncbi.nlm.nih.gov/pubmed/19910376 2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21483019 2012 results in: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3394993/ 2013 substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/22832202 2014 placebo arm results in: http://www.ncbi.nlm.nih.gov/pubmed/25292294 2015 extended long-term follow-up results in: http://www.ncbi.nlm.nih.gov/pubmed/25497694 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27400912 2017 results in: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5455424/ 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28661758 2021 results in https://pubmed.ncbi.nlm.nih.gov/33656637/ (added 04/03/2021)

研究设计

研究类型
Interventional

入排标准

性别
Female

入选标准

  • •To be eligible, women must satisfy at least one of the entry criteria listed below:
  • •1. A mammogram must have been taken within the last year indicating no malignant disease
  • •2. A signed consent form must have been obtained
  • •Entry criteria:
  • •The entry criteria was based on a relative risk of at least two-fold for women aged 45-70 years, four-fold for women aged 40-44 years and ten-fold for women aged 35-39 years.
  • •Age 45-70 years:
  • •1. First degree relative who developed breast cancer at age 50 or less
  • •2. First degree relative who developed bilateral breast cancer
  • •3. Two or more first or second degree relatives who developed breast cancer
  • •4. Nulliparous and a first degree relative who developed breast cancer
  • •5. Benign biopsy with proliferative disease and a first degree relative who developed breast cancer
  • •6. Lobular carcinoma in situ
  • •7. Atypical ductal or lobular hyperplasia in a benign lesion
  • •8. Women at high risk who do not fit into the above categories (risk equivalent)*
  • •* These women must have clearly apparent family history indicating at least two fold increased risk of breast cancer.
  • •Age 40-44 years
  • •8. Two or more first or second degree relatives who developed breast cancer at age 50 or less
  • •9. First degree relative with bilateral breast cancer who developed the first breast cancer at age 50 or less
  • •10. Nulliparous and a first degree relative who developed breast cancer at age 40 or less
  • •11. Benign biopsy with proliferative disease and a first degree relative who developed breast cancer at age 40 or less
  • •12. Lobular carcinoma in situ
  • •13. Atypical ductal or lobular hyperplasia in a benign lesion
  • •14. Women at high risk who do not fit into the above categories (risk equivalent)*
  • •* These women must have clearly apparent family history indicating at least four fold increased risk of breast cancer.
  • •Age 35-39 years:
  • •15. Two or more first degree relatives who developed breast cancer at age 50 or less
  • •16. First degree relative with bilateral breast cancer who developed the first breast cancer at age 40 or less
  • •17. Lobular carcinoma in situ
  • •18. Women at high risk who do not fit into the above categories (risk equivalent)*
  • •* These women must have clearly apparent family history indicating at least ten fold increased risk of breast cancer.

排除标准

  • •1. Pregnant, or at pregnancy risk. If necessary, pre and peri menopausal women must use non-hormonal contraception during the trial
  • •2. Any previous cancer (except non-melanoma skin cancer or in situ cancer of the cervix)
  • •3. Life expectancy of less than 10 years or other medical condition more serious than the risk of breast cancer
  • •4. Psychologically and physically unsuitable for five years tamoxifen or placebo therapy
  • •5. Current treatment with anti-coagulants
  • •6. Previous deep vein thrombosis or pulmonary embolus
  • •7. Current tamoxifen use

研究者

发起方
Queen Mary University of London (UK)

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