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

Not Applicable

Completed

• Conditions: Breast cancer chemoprevention; Cancer; Breast cancer

• Registration Number: ISRCTN91879928
• Lead Sponsor: Queen Mary University of London (UK)

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-01
• Study Completion: 2011-03-30
• Last Update Posted: 15 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 7000

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The development of histologically confirmed breast cancer, both invasive and non-invasive (i.e. including ductal carcinoma in situ [DCIS].

Secondary Outcome Measures

Name	Time	Method
Other cancers, other serious medical conditions or side effects.