NCT00079248Unknown不适用
UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer
Institute of Cancer Research, United Kingdom2 个研究点 分布在 1 个国家开始时间: 2002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
- 发起方
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Hormone replacement therapy may be effective in relieving symptoms of menopause, such as hot flashes, night sweats, and vaginal dryness, without causing a recurrence of breast cancer.
PURPOSE: This randomized clinical trial is studying hormone replacement therapy to see how well it works in relieving symptoms of menopause in postmenopausal women with previous stage I or stage II breast cancer.
详细描述
OBJECTIVES:
- Compare disease-free survival and overall survival of postmenopausal women with prior stage I or II breast cancer treated with hormone replacement therapy (HRT) vs nonhormonal alternatives to HRT.
- Compare relief of menopausal symptoms and quality of life of patients treated with these regimens.
- Compare cardiovascular and osteoporotic events in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (< 40 years vs ≥ 40 years), and years from diagnosis (≤ 2 vs > 2 to < 5 vs ≥ 5). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral or transdermal HRT comprising estrogen with or without progesterone for at least 2 years.
- Arm II: Patients are offered advice on nonhormonal HRT alternatives. Menopausal symptoms are assessed at baseline, at 3, 6, and 12 months, every 6 months for 4 years, and then annually thereafter. Quality of life is assessed at baseline, at 3, 6, and 12 months, every 6 months for 1 year, and then annually thereafter.
Patients are followed every 6 months for 3 years and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Prior diagnosis of stage I or II breast cancer
- •No clinical evidence of recurrence
- •Meets criteria for 1 of the following:
- •Amenorrheic for at least the past 6 months
- •Radiotherapy- or chemically-induced ovarian suppression allowed
- •Prior surgical bilateral oophorectomy
- •Experiencing vasomotor symptoms (i.e., hot flashes or night sweats) with or without vaginal dryness
- •No undiagnosed postmenopausal bleeding
- •No ductal carcinoma in situ or lobular carcinoma in situ alone
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Postmenopausal
- •Menopausal status
- •Postmenopausal
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •No severe, active liver disease with abnormal liver function tests
- •No acute, intermittent porphyria
- •Fibrinolysis and coagulation normal
- •Not specified
- •Cardiovascular
- •No prior deep vein thrombosis
- •Thrombophlebitis or superficial phlebitis alone allowed
- •No prior retinal vein thrombosis
- •No prior pulmonary embolism
- •Not pregnant
- •No prior alcohol, drug, or chemical abuse
- •No other prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •More than 3 months since prior oral or transdermal hormone replacement therapy (HRT)
- •More than 5 years since prior HRT implant
- •No other concurrent HRT
- •No concurrent gonadotropin-releasing hormone agonists (e.g., goserelin) if less than 2 years of planned treatment remains
- •No other concurrent low-dose progestins
- •No concurrent tibolone
- •No concurrent phytoestrogens (e.g., black cohosh, red clover, or soy)
- •Radiotherapy
- •See Disease Characteristics
- •See Disease Characteristics
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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