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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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Footnotes

  • Sources of funding: Cancer Research UK, and National Health and Medical Research Council Australia.

  • For correspondence: Professor J Cuzick, IBIS Trials Centre, London, UK. Jack.Cuzick{at}cancer.org.uk

  • * See glossary.

  • Information provided by author.