NCT00078832

Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer

International Breast Cancer Intervention Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,864 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	anastrozole	aromatase inhibitor
DRUG	placebo	Arimidex placebo

Timeline

• Start date: 2003-09-01
• Primary completion: 2013-12-01
• Completion: 2021-05-31
• First posted: 2004-03-09
• Last updated: 2021-10-06

Locations

74 sites across 14 countries: Australia, Belgium, Chile, Denmark, Finland, Germany, Hungary, Ireland, Italy, Malta, Portugal, Switzerland, Turkey (Türkiye), United Kingdom