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Tibolone increases the risk of breast cancer recurrence.
12 February 2009

The LIBERATE trial, a randomised controlled trial of tibolone vs placebo in women with a history of breast cancer, was stopped 7 months early in light of a significantly increased frequency of recurrence of breast cancer in the tibolone group compared with women on placebo.

There were 1579 women in the tibolone group and 1569 in the placebo group.  When the study was stopped there were 237 cases of recurrent breast cancer in the active group compared with 165 in those on placebo, with a hazard ratio of 1.4.

The advice to healthcare professionals is that tibolone should not be used in women with known or suspected breast cancer, or in those with a history of breast cancer.

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