Effect of tibolone on breast cancer recurrence: LIBERATE trial bone sub-study

Abstract #66 LIBERATE, a randomized, placebo controlled, double blind trial studied the effect of tibolone (Livial), a tissue selective hormone replacement therapy (HRT) on breast cancer (BC) recurrence, aiming to demonstrate non-inferiority of treatment compared to placebo. In the LIFT trial of osteoporotic women, tibolone prevented BC development. Design and Method: Women with surgically treated BC (T1-3, N0-2, M0) within the last 5 years complaining of vasomotor symptoms, were randomly assigned to tibolone 2.5mg daily or placebo treatment for a maximum of 5 years. Adequate sample size was estimated to be >1500 in each arm. A bone mineral density (BMD) sub-study of 724 patients (454 Caucasian; 270 Asian) was enrolled utilizing DXA scanning at baseline and 2 years. Results: Between 2002 and 2004, 3,148 women were randomized in 31 countries; 1579 to tibolone and 1569 to placebo. Mean age at randomization was 52.7 years (28.0-75.0) and mean time since surgery was 2.1 years. In total 58% of women recruited were node positive and 78% ER positive. The trial closed prematurely in July 2007, with a median follow-up of 3.1 years (0.01-4.99) per patient, because an increased risk of BC recurrence occurred on tibolone HR 1.40 (1.14-1.70; p Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 66.