The effect of tibolone in postmenopausal women receiving tamoxifen after surgery for breast cancer: a randomised, double‐blind, placebo‐controlled trial

Abstract

Objective To assess the effects of tibolone on climacteric symptoms, endometrium and serum lipid/ lipoproteins in postmenopausal women receiving tamoxifen after surgery for breast cancer. Design Double-blind, randomised, placebo-controlled, multicentre pilot study.Setting Hospital outpatient clinic.Sample Seventy postmenopausal women receiving tamoxifen following surgery for early breast cancer.Methods Women received 20 mg/day oral tamoxifen plus either 2.5 mg/day oral tibolone or placebo for 12 months. Main outcome measures Frequency and severity of hot flushes (diary cards); intensity of hot flushes and sweats (Landgren scale); interference of hot flushes and sweats with normal life; frequency and intensity of other climacteric symptoms; endometrial thickness and histology; vaginal bleeding; breast cancer recurrence and serum lipid/lipoproteins. Results Daily card data showed no change in the daily number of hot flushes with either tibolone or placebo (P ¼ 0.219) after three months. There was a significant reduction in the severity of flushes with tibolone compared with placebo (À0.4 vs 0.2, P ¼ 0.031). The Landgren scale showed a mean change in the number of hot flushes of À0.6 with tibolone and þ1.1 with placebo after 12 months (P ¼ 0.022). Endometrial biopsies were normal and vaginal bleeding was similar in both groups. A significant decrease in triglycerides (À23% vs 1.4%) and HDL (À12% vs 19%) was seen with tibolone compared with placebo after 12 months. Conclusions Tibolone prevented an increase in hot flushes in postmenopausal women given tamoxifen following surgery for breast cancer without untoward effects on the endometrium. Beneficial effects on serum lipid profile were noted.

Effect of Tibolone on Breast Cancer Cell Proliferation in Postmenopausal ER+ Patients: Results from STEM Trial

“…In addition, Kroiss et al (24) have shown the efficacy of tibolone in the reduction of hot flushes in Table 3 The favorable therapeutic profile has led to the design of the ''Livial Intervention following Breast Cancer; Efficacy, Recurrence, and Tolerability Endpoints'' (LIBERATE) study, an international multicenter trial that has recruited >3,000 patients and that is expected to report a first analysis by end of 2007. The aim of the study is to show noninferiority of tibolone compared with placebo in respect to breast cancer recurrence and to show that tibolone is safe and effective in women with breast cancer and vasomotor symptoms.…”

Tibolone decreases Lipoprotein(a) levels in postmenopausal women: A systematic review and meta-analysis of 12 studies with 1009 patients

“…Bjarnason et al [33] Gallagher et al [34] Kalogeropou-los et al [35] Kroiss et al [36] Lloyd et al [37] Year …”

Safety of tibolone in the treatment of vasomotor symptoms in breast cancer patients—Design and baseline data ‘LIBERATE’ trial

“…5 Tibolone is a synthetic steroid with a clinical profile that differs from that of both classical estrogen-based HT, as well as from that of selective estrogen receptor modulators (SERMs). 13,14 Tibolone has shown its efficacy in reducing climacteric symptoms both in healthy menopausal women, 15 as well as in women receiving tamoxifen 16 or GnRH analogs 17 after surgery for breast cancer. The mode of action of tibolone differs from that of conventional estrogen receptor ligands.…”

“…There were no recurrences in either group during the 12-month study. 16 Although these findings are promising, definitive safety data can only come from a large, long-term controlled clinical trial such as the LIBERATE (livial intervention following breast cancer: efficacy, recurrence and tolerability endpoints) study. As tibolone has been increasingly prescribed preferentially in disease-free breast cancer patients who persistently seek help for their often disabling menopausal complaints, 25 such a trial is highly warranted.…”