LIBERATE trial: A safety study of tibolone in breast cancer patients–design and baseline data
MW Beckmann, JM Foidart, NJ Bundred, P Kenemans, E Kubista, B v. Schoultz, P Sismondi, P Sismondi, R Vassilopoulou-Sellin, CH Yip, R Kimmig · Geburtshilfe und Frauenheilkunde · 2006 · Heft 09
Bibliografische Angaben
Zusammenfassung
Background/Objectives: Hormone therapy is contraindicated in women with a history of breast cancer. A pilot study has shown that tibolone relieves vasomotor symptoms in patients receiving tamoxifen after breast cancer surgery. Studies have also shown that tibolone does not stimulate breast tissue, prevents osteoporosis and might therefore be a promising agent to treat vasomotor symptoms in these women. LIBERATE was designed as a randomized, double-blind 5-year trial to evaluate that tibolone 2.5mg/day (Livial®) is non-inferior to placebo regarding breast cancer recurrence. Secondary objectives are overall surviv…