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Tamoxifen reduced breast cancer risk but increased risks of thromboembolic events and all cause mortality in women
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 QUESTION: In women with an increased risk of breast cancer, does tamoxifen reduce the risk of breast cancer and what are the associated harms?

Design

Randomised (allocation concealed*), blinded {clinicians, patients, data collectors, outcome assessors},* placebo controlled trial with median follow up of 50 months.

Setting

Europe, Australia, and New Zealand.

Patients

7152 women 35–70 years of age (mean age 51 y, 49% postmenopausal) who had an increased risk of breast cancer. Exclusion criteria included previous invasive cancer, previous deep vein thrombosis or pulmonary embolism, anticoagulant use, and pregnancy. Follow up was 99.8%.

Intervention

Women were allocated to receive …

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