CompletedPhase 3ACTRN12610000134022
An international multi-centre study of tamoxifen vs placebo in women at increased risk of breast cancer.
A multicentre trial of Tamoxifen to prevent breast cancer in women at increased risk of breast cancer.
Sponsor
Queen Mary University of London
Enrollment
7,000 participants
Start Date
Dec 1, 1992
Study Type
Interventional
Conditions
Summary
A study to evaluate the reduction in incidence of, and mortality from, breast cancer associated with taking tamoxifen daily for five years
Eligibility
Sex: FemalesMin Age: 45 YearssMax Age: 70 Yearss
Inclusion Criteria23
- Women must satisfy at least one of the entry criteria listed below.
- A) Age 45-70 with at least one of the following:
- Breast cancer in mother, sister or daughter diagnosed under the age of 50
- Mother, sister or daughter with cancer in both breasts at any age
- Any two first or second degree relatives (blood relatives) with breast cancer
- Having no children, and with a mother or sister with breast cancer at any age
- Having had a benign biopsy with proliferative disase and a mother, sister or daughter who developed breast cancer at any age
- Having had a biopsy with lobular carcinoma in situ
- Having had a benign biopsy with atypical ductal or lobular hyperplasia
- "Other" equivalent risk to the above (to be confirmed by the Study Chairman
- B) Age 40-44 with at least one of the following:
- Any two first or second degree relatives (blood relatives) with breast cancer under the age of 50
- Mother, sister, or daughter with breast cancer in both breasts under the age of 50
- Having no children, and a mother or sister with breast cancer under the age of 40
- Having had a benign biopsy with proliferative disease and a mother, sister or daughter with breast cancer under the age of 40
- Having had a biospy with lobular carcinoma in situ
- Having had a benign biopsy with atypical ductal or lobular hyperplaisa
- "Other" equivalent risk to the above (to be confirmed by the study chairman)
- C) Age 35-39 with at least one of the following:
- Two relatives, mother, sister or daughter with breast cancer under the age of 50
- Mother, sister or daughter with breast cancer in both breasts under the age of 40
- Having had a biopsy with lobular carcinoma in situ
- "Other" equivalent risk to the above (to be confirmed by the study chairman)
Exclusion Criteria6
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Arm A: Tamoxifen 20 mg/day tablet orally for 5 years
Arm A: Tamoxifen 20 mg/day tablet orally for 5 years
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12610000134022