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DOI: 10.1055/s-2006-952500
LIBERATE trial: A safety study of tibolone in breast cancer patients–design and baseline data
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 survival as well as effects on vasomotor symptoms, BMD and health-related QoL. Methods: Patients were eligible with treated invasive breast carcinoma (T1–3, N0–2, M0). The primary end-point (confirmed by blinded adjudication) 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: Recruitment was completed in December 2004. 3149 patients were randomized at 245 centers in 31 countries worldwide. The mean age was 53 years, the mean body mass index 27, and the mean time since surgery 2.1 years. The mean daily number of hot flushes and sweating episodes was 7 and 6, respectively. A pathological tumor size of >2.0 cm (T2/3) was originally reported for 48% of the patients and a node positive status (N1/2) for 58%. 74% received tamoxifen and 9% aromatase inhibitors. Regular unblinded safety reviews performed so far by an independent DSMB have led to recommendations to continue without modification. Discussion: Tibolone has been shown to relieve vasomotor symptoms after breast cancer surgery. Several trials investigating the effects of E(P)T on breast cancer risk (e.g. HABITS) were stopped prematurely. The LIBERATE trial remains the largest and only ongoing, well-controlled study in this field investigating breast safety.