International Breast Cancer Intervention Study
Overview
- Phase
- Phase 3
- Intervention
- anastrozole
- Conditions
- Breast Cancer
- Sponsor
- Queen Mary University of London
- Enrollment
- 3864
- Locations
- 73
- Primary Endpoint
- Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Anastrozole may be effective in preventing breast cancer.
PURPOSE: This randomized clinical trial is studying how well anastrozole works in preventing breast cancer in postmenopausal women who are at increased risk for the disease.
Detailed Description
OBJECTIVES: Primary * Determine the effectiveness of anastrozole in preventing breast cancer in postmenopausal women at increased risk for the disease. Secondary * Determine the role of this drug in preventing estrogen receptor-positive breast cancer in these participants. * Determine the effect of this drug on breast cancer mortality in these participants. * Determine the effect of this drug on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these participants. * Determine the tolerability and acceptability of side effects of this drug in these participants. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to participating center. Participants are randomized to 1 of 2 treatment arms. * Arm I: Participants receive oral anastrozole daily for 5 years. * Arm II: Participants receive an oral placebo daily for 5 years. In both arms, treatment continues in the absence of the development of breast cancer (including ductal carcinoma in situ), a drop in the T-score below minus 4, or the occurrence of a new fragility fracture. Participants are followed for at least a further 5 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK ACCRUAL: A total of 3,864 participants were recruited for this study over 10 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
anastrozole
anastrozole 1mg
Intervention: anastrozole
placebo
anastrozole 1mg PLACEBO
Intervention: placebo
Outcomes
Primary Outcomes
Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years
Time Frame: Dec 2013
Secondary Outcomes
- Breast cancer mortality with median follow-up at 10 years(Dec 2018)