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Q In postmenopausal women at increased risk, what is the comparative efficacy and safety of raloxifene and tamoxifen for preventing invasive breast cancer?
Clinical impact ratings GP/FP/Primary care ★★★★★★☆ Oncology ★★★★★★☆ Endocrine ★★★★★☆☆
METHODS
Design:
randomised controlled trial.
Allocation:
concealed.*
Blinding:
blinded (clinicians, participants, and outcome assessors).*
Follow up period:
mean 3.9 years.
Setting:
nearly 200 clinical centres in North America.
Participants:
19 747 postmenopausal women ⩾35 years of age (mean age 59 y) whose 5 year predicted risk of breast cancer was ⩾1.66% (mean 4.03%) based on the Gail model. Exclusion criteria included recent hormone therapy use; stroke or venous thromboembolism (VTE) history; cancer in the previous 5 years; and uncontrolled atrial fibrillation, diabetes, or hypertension.
Intervention:
raloxifene, 60 mg/day (n = 9875), or tamoxifen, …
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