NCT00026286已完成3 期
A Phase III Prospective, Randomized, Double-Blind Clinical Trial of Hormone Replacement Therapy In Postmenopausal Women With A History Of Node-Negative Or Ductal Carcinoma In Situ Who Are Receiving Adjuvant Tamoxifen
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 24
研究概览
简要总结
RATIONALE: Hormone replacement therapy may be effective in managing the hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of hormone replacement therapy in managing hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of hormone replacement therapy in managing hot flashes and menopausal vaginal symptoms in postmenopausal women with a history of node-negative invasive carcinoma or ductal carcinoma in situ of the breast who are receiving adjuvant tamoxifen.
- Determine the effect of this regimen on blood coagulation and lipid profiles in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior hysterectomy (yes vs no), symptom complex (vasomotor vs vaginal vs both), duration of hot flashes (less than 1 year or no hot flashes vs 1 year or more), and average daily number of hot flashes (less than 10 or none vs 10 or more). Patients are randomized to one of two treatment arms.
- Arm I: Patients who have not undergone prior hysterectomy receive oral medroxyprogesterone once daily for 6 months. If, after 1 month, symptoms do not resolve, patients receive oral conjugated estrogens once daily in addition to medroxyprogesterone for 5 months. Patients who have undergone prior hysterectomy receive oral conjugated estrogens once daily for 6 months.
- Arm II: Patients receive oral placebo once daily for 6 months. Quality of life is assessed at baseline and months 1, 2, 3, and 6.
Patients are followed every 3 months for 2 years, 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
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed node-negative invasive carcinoma or ductal carcinoma in situ of the breast
- •No contralateral breast cancer
- •No recurrent or metastatic disease
- •Completion of active non-hormonal therapy for breast cancer
- •Receiving tamoxifen (20 mg/day) for at least 3 months prior to study and plan to continue drug while on study
- •Hot flashes severe enough to seek medical intervention (at least 7-8 moderate to severe hot flashes per day or 60 per week at baseline) AND/OR
- •Vaginal symptoms, including dyspareunia, vaginal dryness, irritation, or thinning due to estrogen deficiency
- •If uterus present, no prior histologically confirmed adenomatous or atypical endometrial hyperplasia or endometrial carcinoma AND no concurrent endometrial cancer confirmed by pelvic exam within the past year
- •No active endometriosis
- •No unexplained vaginal bleeding
- •Hormone receptor status:
- •Estrogen and progesterone receptor status known for patients with invasive breast cancer
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Postmenopausal
- •No menstrual period for more than 12 months OR prior bilateral oophorectomy
- •Must be over 55 years of age OR have documented follicle-stimulating hormone levels in postmenopausal range if one or both ovaries remain after prior hysterectomy
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular:
- •No prior superficial or deep venous or arterial thrombosis
- •No serious venous stasis disease
- •No pulmonary embolus
- •Must be able to read and speak English
- •No lower extremity trauma, swelling, or tenderness within the past 4 weeks
- •No active gallbladder disease
- •No migraine headaches
- •No other prior malignancy unless curatively treated with no evidence of recurrence
- •No concurrent seizure disorder requiring anti-seizure medication
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •See Disease Characteristics
- •No other concurrent estrogen or hormone replacement therapy
- •No concurrent clonidine, bellergal, progestational agent, or methyldopa for hot flashes
- •No concurrent topical vaginal estrogen cream (e.g., Estring or Vagifem) for patients with vaginal symptoms only
- •Radiotherapy:
- •Not specified
- •At least 4 weeks since prior surgery
- •At least 12 months since prior treatment for congestive heart failure
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (24)
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