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• W2012093670 abstract "The Livial Intervention following Breast cancer: Efficacy, Recurrence, And Tolerability Endpoints (LIBERATE) trial was a multinational, placebo-controlled, randomized study of women with vasomotor symptoms who had had breast cancer surgically treated within the previous 5 years [ [1] Kenemans P. Bundred N.J. Foidart J.-M. et al. Safety and efficacy of tibolone in breast-cancer patients with vasomotor symptoms: a double-blind, randomised, non-inferiority trial. Lancet Oncol. 2009; https://doi.org/10.1016/S1470-2045(08)70341-3 Abstract Full Text Full Text PDF PubMed Scopus (244) Google Scholar ]. The study was designed to demonstrate that tibolone was superior to placebo, but when the DMSB notified the sponsor (Schering-Plough, formerly Organon) that there appeared to be an excess of breast cancers in the treated group, the sponsor canceled the trial on July 31, 2007, 5 months before its scheduled end. The median duration of participation and treatment was about 3 years, with a wide range from a few weeks to almost 5 years. The participants used a variety of adjuvant treatments, mostly tamoxifen, 66.8%; 6.5% used aromatase inhibitors. The dose of tibolone was 2.5 mg daily. Final numbers for analysis were 1556 women in the treated group and 1542 in the placebo group. The women ranged in age from under 40 to 79, with a mean age of 52.7 years. 57.8% had positive lymph nodes and 70% had a tumor stage of IIA or higher. Estrogen receptor status was known in 2808 women in whom the tumors were estrogen receptor positive in 77.8%. In the intent-to-treat analysis, the hazard ratio for recurrent breast cancer in the tibolone-treated women was 1.40 (CI = 1.14–1.70). The absolute risk for tibolone was 51 cancers per 1000 women per year, and 36 in the placebo group. The increase occurred only in women with estrogen receptor-positive tumors. There was no difference in mortality rates between the two groups during the 5-year study period. There were no differences in cardiovascular events or gynecologic cancers, and not surprisingly, vasomotor symptoms, quality of life measures, and bone density improved with tibolone treatment." @default.
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• W2012093670 date "2009-05-01" @default.
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• W2012093670 title "The LIBERATE tibolone trial in breast cancer survivors" @default.
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• W2012093670 doi "https://doi.org/10.1016/j.maturitas.2009.03.001" @default.
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