EUCTR2004-002418-12-DK进行中（未招募）不适用
An open-label, randomized, multicenter safety study to evaluate the skeletal and lipid profile effects of letrozole and tamoxifen in postmenopausal women with resected, receptor positive early breast cancer - N/A
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 245
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Female sex.
- •2. Postmenopausal hormone status defined as:
- •Patients with menostasis > 12 months or history of oophorectomy
- •Patients = 55 years with history of hysterectomy or having continued/renewed menstruation on cyclic hormone treatment
- •Patients of 50-54 years: Menopausal status is determined on the basis of FSH/LH values
- •3. Histologically confirmed resected breast cancer AND eligible for adjuvant endocrine therapy. As a minimum, patients must have receptor positive tumours, which is defined either as ER and/or PgR =10 fmol/mg cytosol protein; or = 10% of the tumour cells positive by immunocytochemical evaluation.
- •4. Adequate bone marrow function (WBC > 3.0 x 10 9 /L, platelets = 100.0 x 10 9 /L, and haemoglobin > 10 g/dL).
- •5. Documented evidence of adequate renal function (creatinine < 180 µmol/L) and hepatic function (bilirubin < 30 µmol/L, ALT (SGPT) < 1.5 x upper normal limit of the laboratory).
- •6. Life expectancy at least 24 months.
- •7. Written voluntary informed consent prior to initiation of any study procedure.
- •8. Willingness to undergo all scheduled tests and examinations for evaluation of bone density and bone metabolism, and lipid profiles in addition to the standard assessments for monitoring their breast cancer status.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with distant metastases as defined by the criteria of the Danish Breast cancer group.
- •2. Pre-existing bone disease (e.g. osteomalacia, osteogenesis imperfecta, Paget’s disease).
- •3. Patients receiving bisphosphonates for more than 3 months before randomization.
- •4. Chronic treatment with drugs known to interfere with bone metabolism, e.g.
- •Anticonvulsants within the past year.
- •Corticosteroids at doses greater than the equivalent of 5 mg/day prednisone for more than two weeks in the past 6 months.
- •Any previous treatment with sodium fluoride at daily doses = 5 mg/day for a period exceeding 1 month.
- •Anabolic steroids in the past 12 months.
- •Long term use of coumarins derivatives and heparin at the time of randomization.
- •5. Metabolic diseases known to interfere with bone metabolism (e.g. Hyper-, Hypoparathyroidism, uncontrolled thyroid disease, Cushing Disease, Vitamin D deficiency, Malabsorption Syndrome, etc.).
- •6. Treatment with lipid lowering agents within the 3 months prior to randomization (this exclusion criteria does not apply to patients randomized in the U.K.).
- •7. Patient receiving other anti-cancer treatment.
- •8. Previous neoadjuvant / adjuvant chemotherapy and /or previous adjuvant endocrine therapy (e.g. anti-estrogens, aromatase inhibitors).
- •9. History of previous or concomitant malignancy within the past 5 years other than adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for five years. Patients with endometrial cancer and/or invasive breast cancer at any time in their medical history are excluded. Patients with invasive bilateral breast cancer are excluded. Patients with vaginal discharge/ vaginal bleeding with evidence of malignancy are excluded
- •10. Any other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.
- •11. History of cardiovascular diseases (including earlier known acute myocardial infarction or angina pectoris), cerebrovascular events, venous thromboembolic events (including deep-vein thromboses).
- •12. History of non-compliance to medical regimens and patients who are considered potentially unreliable.
- •13. History of systemic investigational drugs use within the past 30 days.
- •14. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •15. Current use of hormone replacement therapy (HRT must be stopped at least 4 weeks before study treatment is initiated)
研究者
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