LIBERATE trial: A safety study of tibolone in breast cancer surgery patients
MW Beckmann, J Foidard, N Bundred, P Kenemans, E Kubista, B von Schoultz, P Sismondi, R Vassilopoulou-Sellin, C Yip, R Kimmig · Senologie - Zeitschrift für Mammadiagnostik und -therapie · 2006 · Heft 10
Bibliografische Angaben
Zusammenfassung
Background/Objectives: Hormone therapy is contraindicated in women with a history of breast cancer. Tibolone does not stimulate breast tissue and is an agent to treat vasomotor symptoms. LIBERATE is a randomized, double-blind 5-year trial to evaluate that tibolone 2.5mg/day is non-inferior to placebo. Methods: Patients had treated invasive breast carcinoma (T1–3, N0–2, M0). The primary end-point is breast cancer recurrence, including contralateral.. The primary analysis will be performed mid 2007, with a follow-up analysis on all data in 2009. Baseline data: Until December 2004. 3149 patients were randomized at…