NCT00031850已完成不适用
A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer
Institute of Cancer Research, United Kingdom2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2000年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of raloxifene and goserelin may be effective in preventing breast cancer.
PURPOSE: Randomized pilot study to study the effectiveness of combining raloxifene and goserelin in preventing breast cancer in women who have a family history of breast cancer.
详细描述
OBJECTIVES:
- Compare the feasibility of raloxifene and goserelin versus no medical intervention in women at high genetic risk for developing breast cancer.
- Compare the incidence of adverse effects in patients treated with these regimens.
- Compare the effect of these regimens on bone density, biochemical markers of bone turnover, and lipid profiles in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive goserelin subcutaneously once every month and oral raloxifene daily for 6-12 months.
- Arm II: Patients are screened for breast cancer every 6 months. In both arms, patients undergo annual mammograms.
Quality of life is assessed at baseline and at 1, 3, 6, and 12 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •High genetic risk of developing breast cancer defined as one or more of the following:
- •BRCA1 or BRCA2 germ-line mutation
- •First-degree relative of known BRCA1 or BRCA2 mutation carrier
- •Family with 4 or more relatives diagnosed with female or male breast cancer or ovarian cancer before the age of 60
- •Two first-degree relatives diagnosed with breast cancer before the age of 40
- •p53 germ-line mutation (classical Li-Fraumeni syndrome (LFS) only)
- •First-degree relative of a carrier in a family with classical LFS
- •Risk equivalent to any of the above confirmed by clinical geneticist
- •No evidence of breast cancer by mammography
- •Suspicious lesions must be confirmed as non-malignant
- •No prior breast cancer
- •No prior prophylactic mastectomy
- •No plan for alternative prevention measures within the next 12 months
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status:
- •Premenopausal (follicle-stimulating hormone in premenopausal range if not menstruating)
- •Performance status:
- •Not specified
- •Life expectancy:
- •More than 10 years (excluding breast cancer risk)
- •Hematopoietic:
- •Not specified
- •Adequate liver function
- •Adequate renal function
- •Cardiovascular:
- •No prior deep vein thrombosis
- •No prior pulmonary embolism
- •Not pregnant
- •Fertile patients must use effective nonhormonal contraception
- •No psychological disorder that would preclude study compliance
- •No prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or cervical cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •No concurrent hormonal therapy (e.g., oral contraception or hormone replacement therapy)
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- •At least 30 days or 5 half-lives since prior investigational drugs
- •No concurrent anticoagulants
排除标准
- 未提供
研究者
研究点 (2)
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