None listed
Conditions
Brief summary
A study to evaluate the reduction in incidence of, and mortality from, breast cancer associated with taking tamoxifen daily for five years
Interventions
Arm A: Tamoxifen 20 mg/day tablet orally for 5 years
Sponsors
Queen Mary University of London
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
45 Years to 70 Years
Healthy volunteers
No
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
Outcome results
None listed