Tamoxifen for the Prevention of Breast Cancer in High-Risk Women

• Status: Active, not recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The International Breast Cancer Intervention Study I (IBIS-I) was designed to investigate the use of tamoxifen in preventing breast cancer in women with a higher risk of developing the disease. Recruitment of women to IBIS-I ended in March 2001 and it recruited 7154 women from 36 centres in 9 countries. The results of the study showed that tamoxifen reduced the incidence of breast cancer by one third in these high risk women but with some serious side effects. IBIS-II was designed to continue the work started in IBIS-I by examining the role of anastrozole in the prevention of breast cancer which we hope will reduce breast cancer by even more than tamoxifen with less serious side effects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cancer Research, United Kingdom; Queen Mary University of London
• Treatments: Tamoxifen

Criteria

The entry criteria are 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

19)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)*