An international multi-centre study of tamoxifen vs placebo in women at increased risk of breast cancer.

Phase 3

Completed

• Conditions: Prevention of Breast cancer; Cancer - Breast

• Registration Number: ACTRN12610000134022
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

Women must satisfy at least one of the entry criteria listed below.
A) Age 45-70 with at least one of the following:
1. Breast cancer in mother, sister or daughter diagnosed under the age of 50
2. Mother, sister or daughter with cancer in both breasts at any age
3. Any two first or second degree relatives (blood relatives) with breast cancer
4. Having no children, and with a mother or sister with breast cancer at any age
5. Having had a benign biopsy with proliferative disase and a mother, sister or daughter who developed breast cancer at any age
6. Having had a biopsy with lobular carcinoma in situ
7. Having had a benign biopsy with atypical ductal or lobular hyperplasia
8. Other equivalent risk to the above (to be confirmed by the Study Chairman

B) Age 40-44 with at least one of the following:
9. Any two first or second degree relatives (blood relatives) with breast cancer under the age of 50
10. Mother, sister, or daughter with breast cancer in both breasts under the age of 50
11. Having no children, and a mother or sister with breast cancer under the age of 40
12. Having had a benign biopsy with proliferative disease and a mother, sister or daughter with breast cancer under the age of 40
13. Having had a biospy with lobular carcinoma in situ
14. Having had a benign biopsy with atypical ductal or lobular hyperplaisa
15. Other equivalent risk to the above (to be confirmed by the study chairman)

C) Age 35-39 with at least one of the following:
16. Two relatives, mother, sister or daughter with breast cancer under the age of 50
17. Mother, sister or daughter with breast cancer in both breasts under the age of 40
18. Having had a biopsy with lobular carcinoma in situ
19. Other equivalent risk to the above (to be confirmed by the study chairman)

Exclusion Criteria

a) Women with previous deep vein thrombosis or pulmonary embolus are excluded from the study
b) Women must not use hormonal contraception during the trial
c) Pregnant or at pregnacy risk
d) Life expectany less than 10 years
e) Currently being treated with anticoagulants
f) Previous cancer

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of histologically confirmed breast cancer (both invasive and non-invasive i.e. including Ductal Carcinoma Insitu (DCIS)).[Interim analysis of the data will be by blinded analysis at 6 monthly intervals up to 5 years from baseline];Breast cancer mortality.[Interim analysis of the data submitted on case record forms will be analysed to assess breast cancer mortality at 6 monthly intervals up to 5 years from baseline];All cause and cause-specific mortality.[Interim analysis of the data submitted on case record forms will be analysed to assess breast cancer mortality at 6 monthly intervals up to 5 years from baseline]

Secondary Outcome Measures

Name	Time	Method
Occurrence of and mortality from myocardial infarction.[Blood pressure and cholesterol assays will be taken at year 1 and year 5 and interim analysis of the data submitted on case record forms will be analysed to assess breast cancer mortality at 6 monthly intervals up to 5 years from baseline]