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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00078832
Study type Interventional
Source Queen Mary University of London
Contact
Status Completed
Phase Phase 3
Start date September 2003
Completion date May 31, 2021

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