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Contemporary adjuvant chemotherapy regimens often induce premature menopause in patients with early-stage breast cancer. Tibolone (Livial; a synthetic steroid that is approved in 90 countries, albeit not in the U.S.) has been shown to be effective for treating the resulting symptoms. However, data concerning the agent’s effect on risk for developing breast cancer are conflicting: Findings from the Million Women Study showed that tibolone was associated with excess risk for breast cancer (hazard ratio, 1.45; P<0.0001; Lancet 2003; 362:419), whereas more-recent results showed that it was associated with diminished risk (HR, 0.32; P=0.04; N Engl J Med 2008; 359:697).
To assess tibolone’s influence on breast cancer recurrence in postmenopausal w…