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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00408863 |
Postmenopausal women with a history of breast cancer often suffer from climacteric symptoms such as hot flushes and sweating episodes. Conventional hormone therapy is not allowed in such patients because there are indications that hormones may cause breast cancer to recur.
Tibolone is a steroid with estrogenic, progestogenic and androgenic activity and is registered for treatment of climacteric complaints. Tibolone has a pharmacologic and clinical profile that is different from conventional hormones. In contrast to conventional hormones, tibolone does not increase breast density and causes less breast pain.
The LIBERATE study is a study in which the safety and efficacy of tibolone has been investigated in postmenopausal women that have been treated for breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Climacteric Symptoms |
Drug: tibolone 2.5 mg/day Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Investigate Safety and Efficacy of Tibolone (Org OD14) in Women With Climacteric Symptoms and a History of Breast Cancer |
Enrollment: | 3148 |
Study Start Date: | May 2002 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
A growing proportion of women diagnosed with early stage breast cancer seek help with vasomotor and sexual complaints. Frequently, these symptoms result from adjuvant cancer treatment, irrespectively whether this is hormonal (e.g. tamoxifen, aromatase inhibitors), cytotoxic, or surgical (oophorectomy) in nature. Estrogen-containing hormone therapy is effective, but considered unsafe. Non-hormonal therapy is less effective. Tibolone, which does not increase mammographic breast density, has proven to be effective and thus could be an important treatment option for women persistently seeking help.
The objective of this trial is to demonstrate safety, efficacy and tolerability of oral 2.5 mg tibolone daily in breast cancer patients, who, after surgery, have no evidence of disease and who suffer from climacteric complaints. Primary study endpoint is breast cancer recurrence, including primary contralateral breast cancer. Secondary outcome variables include menopausal symptoms, bone mineral density and health-related quality of life.
Patients were eligible for this study when they had been surgically treated within the previous 5 years for histologically confirmed T1-3, N0-2, M0 breast cancer and had to have vasomotor symptoms, with a last menstruation at least 12 months before (or bilateral oophorectomy).
The LIBERATE Trial has been designed to show non-inferiority of tibolone compared to placebo. Adequate sample size was estimated to be at least 1500 subjects in each arm, assuming a breast cancer recurrence rate of 5% per year in the first 3 years and an dropout rate of 5% per year.
The LIBERATE Study has successfully included the appropriate number of women with the proper risk profile so that significant results can be obtained in relation to safety and efficacy of tibolone in breast cancer patients with menopausal complaints.
Ages Eligible for Study: | up to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
In subjects with an intact uterus, a 'normal' endometrium, defined as:
Exclusion Criteria:
Study Chair: | Peter Kenemans, MD, PhD | Free University Medical Center, Amsterdam, Netherlands |
Study ID Numbers: | 32974 |
Study First Received: | December 6, 2006 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00408863 |
Health Authority: | Australia: National Health and Medical Research Council; Austria: Agency for Health and Food Safety; Belarus: Ministry of Health; Belgium: Ministry of Social Affairs, Public Health and the Environment; Brazil: Ministry of Health; Chile: Comisión Nacional de Investigación Científica y Tecnológica; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Ministry of Food, Agriculture and Consumer Protection; Hungary: National Institute of Pharmacy; Italy: Ministry of Health; Latvia: State Agency of Medicines; Mexico: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Poland: Ministry of Health; Romania: National Medicines Agency; Russia: Pharmacological Committee, Ministry of Health; Singapore: Health Sciences Authority; Slovakia: State Institute for Drug Control; South Korea: Korea Food and Drug Administration (KFDA); Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Taiwan: Department of Health; Thailand: Ministry of Public Health; Ukraine: State Pharmacological Center - Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Breast cancer Tibolone Climacteric symptoms |
Tibolone Skin Diseases Breast Neoplasms Breast Diseases Recurrence |
Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Agents Antihypertensive Agents Hormones |
Pharmacologic Actions Estrogen Receptor Modulators Anabolic Agents Neoplasms Androgen Antagonists Neoplasms by Site Therapeutic Uses |