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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,864
aromatase inhibitor
Arimidex placebo
Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years
Time frame: Dec 2013
Breast cancer mortality with median follow-up at 10 years
Time frame: Dec 2018
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