Status:
COMPLETED
Livial Intervention Following Breast Cancer; Efficacy, Recurrence and Tolerability Endpoints (LIBERATE)(COMPLETED)(P05885)
Lead Sponsor:
Organon and Co
Conditions:
Breast Cancer
Climacteric Symptoms
Eligibility:
FEMALE
Up to 75 years
Phase:
PHASE3
Brief Summary
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 beca...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Histologically confirmed and surgically treated invasive breast carcinoma (T1/2/3 N0/1/2 M0), irrespective of hormonal (estrogen/progestogen) receptor status.
- Last menstrual bleeding at least 12 months before the start of the study or ovariectomized or hysterectomized or currently being treated with gonadotropin releasing hormone analogs.
- Vasomotor symptoms whether related to natural menopause, ovariectomy, or to breast cancer therapy (chemotherapy, tamoxifen, aromatase inhibitors or other anticancer therapy).
- In subjects with an intact uterus, a 'normal' endometrium, defined as:
- in tamoxifen users: absence of endometrial polyps
- in non-tamoxifen users: double layer endometrial thickness \<=4 mm as assessed by TVUS or double layer endometrial thickness \>4 mm and \<=8 mm as assessed by TVUS plus an endometrial biopsy result of inactive/atrophic.
- Voluntary written informed consent and willing and able to make reasonable efforts to meet all clinical trial requirements.
Exclusion
- Age \>75 years at baseline.
- Ductal carcinoma in situ (DCIS) of the breast without the existence of invasive breast carcinoma.
- Invasive breast carcinoma having a tumor of any size with direct extension to chest wall or skin (T4) and/or having metastasis to ipsilateral mammary lymph node(s) (N3) and/or having presence of distant metastasis (M1).
- Surgical treatment of the primary breast cancer \>5 years ago.
- History or presence of residual or recurrent breast cancer.
- History or presence of endometrial cancer.
- History or presence of any other malignancy (besides breast cancer and endometrial cancer) within the past 5 years, except for adequately treated basal cell carcinoma of the skin.
- Diagnostic findings suspicious for any malignancy.
- Double layer endometrial thickness \>8 mm as assessed by TVUS in subjects not being treated with tamoxifen.
- Final diagnosis of endometrial biopsy different from inactive/atrophic
- Existence of endometrial polyps as demonstrated by TVUS.
- Undiagnosed vaginal bleeding.
- Abnormal cervical smear (corresponding to PAP IIb or higher)
- Any previous or current unopposed estrogen administration in women with an intact uterus (occasional use of estrogen-containing vaginal cream was allowed after an appropriate washout period - see below).
- Use of systemic estrogens and/or progestogens (including intra-uterine progestogen therapy) and/or tibolone and/or phytoestrogens within 8 weeks prior to baseline; use of transdermal hormone therapy and/or local estrogen applications and/or non-hormonal medication for vasomotor symptoms within 4 weeks prior to baseline.
- Use of progestogen implants or injections and/or estrogen/progestogen injectable therapy within the past 6 months.
- Use of estrogen implants or injections within the past 5 years.
- Use of raloxifene hydrochloride and/or any non-registered investigational drug within the last 8 weeks.
- Active deep vein thrombosis, thromboembolic disorders, or a documented history of these conditions.
- Severe liver disorders.
- Abnormal laboratory values considered to be clinically relevant by the investigator.
- Any disease or condition that is clinically relevant and which, in the opinion of the investigator, would jeopardize the subject's well-being during the course of the trial.
- Known hypersensitivity to tibolone or any of its components
- Known or suspected pregnancy
- Age \<40 years at baseline and planned breast cancer therapy \<2 years after baseline
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
3148 Patients enrolled
Trial Details
Trial ID
NCT00408863
Start Date
May 1 2002
End Date
October 1 2007
Last Update
February 4 2022
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