Safety of tibolone in the treatment of vasomotor symptoms in breast cancer patients--design and baseline data 'LIBERATE' trial.
Many patients with a history of breast cancer (BC) will suffer from vasomotor symptoms, which can be induced or exacerbated by treatment with tamoxifen or aromatase inhibitors. The LIBERATE trial was designed as a randomized, double-blind, multicenter trial to demonstrate that tibolone 2.5mg/day (Livial) is non-inferior to placebo regarding BC recurrence in women with vasomotor symptoms surgically treated for primary BC within the last 5 years. Secondary objectives are effects on vasomotor symptoms as well as overall survival, bone mineral density and health-related quality of life. Mean age at randomization was 52.6 years, and the mean time since surgery was 2.1 years. The mean daily number of hot flushes and sweating episodes was 7.3 and 6.1, respectively. For the primary tumor, Stage IIA or higher was reported for >70% of the patients. In subjects whose receptor status was known, 78.2% of the tumors were estrogen receptors positive. At randomization, tamoxifen was given to 66.2% of all patients and aromatase inhibitors to 7%. Chemotherapy was reported by 5% at randomization. The adjuvant tamoxifen use in LIBERATE allows a comparison with the Stockholm trial (showing no risk of BC recurrence associated with hormone therapy), which was stopped prematurely subsequent to HABITS. The LIBERATE trial is the largest, ongoing, well-controlled study for treatment of vasomotor symptoms in BC patients.
Kenemans
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P
Department of Special Gynecology, Universitatsklinik fur Frauenheilkunde, Wahringer Gurtel 18-20, A-1090 Wien, Austria. Ernst.Kubista@meduniwien.ac.at
Kubista
E
E
Foidart
J M
JM
Yip
C H
CH
von Schoultz
B
B
Sismondi
P
P
Vassilopoulou-Sellin
R
R
Beckmann
M W
MW
Bundred
N J
NJ
Egberts
J
J
van Os
S
S
Planellas
J
J
D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D047072:Aromatase Inhibitors / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D001342:Autonomic Nervous System Diseases / Q000139:chemically induced / Q000188:drug therapy*; D015519:Bone Density; D001943:Breast Neoplasms / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D009652:Norpregnenes / Q000494:pharmacology* / Q000627:therapeutic use; D011788:Quality of Life; D016019:Survival Analysis; D013629:Tamoxifen / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D016896:Treatment Outcome; D014666:Vasomotor System / Q000187:drug effects*
D018931:Antineoplastic Agents, Hormonal; D047072:Aromatase Inhibitors; D009652:Norpregnenes; D013629:Tamoxifen; C027385:tibolone