A Multicenter Randomized Trial of Sequential Epirubicin and Docetaxel Versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 2
- 主要终点
- Disease-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Combining chemotherapy with hormone therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and tamoxifen with or without docetaxel in treating postmenopausal women who have breast cancer that has spread to the lymph nodes.
详细描述
OBJECTIVES:
- Compare the impact of adjuvant epirubicin with or without docetaxel and concurrent or sequential tamoxifen on time to relapse and overall survival in postmenopausal women with node-positive breast cancer.
- Compare the toxic effects of these regimens in this patient population.
- Compare the quality of life in terms of shift in long term toxicity and differences in recuperation in women treated with these regimens.
- Compare the incidence of thromboembolic events during the first 9 months of study and the influence of such events on compliance in women 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 adjuvant chemotherapy treatment arms within 30 days after surgery.
- Arm I: Patients receive adjuvant epirubicin IV on days 1 and 8. Treatment continues every 28 days for 6 courses.
- Arm II: Patients receive adjuvant epirubicin IV on days 1 and 8. Treatment continues every 28 days for 3 courses. Patients then receive docetaxel IV over 1 hour on day 1. Treatment continues every 21 days for 3 courses.
Patients may be further randomized to one of two tamoxifen arms. Patients not randomized to the tamoxifen arms receive oral tamoxifen daily for 5 years concurrently with adjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven node-positive breast cancer
- •Postmenopausal
- •Last menstrual period more than 12 months before initial surgery OR
- •Any age with prior bilateral oophorectomy OR
- •Age 50 or over with prior hysterectomy without oophorectomy (unrelated to malignancy)
- •No distant metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •See Disease Characteristics
- •Menopausal status:
- •See Disease Characteristics
- •Performance status:
- •WHO (ECOG) 0-1
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm3 OR
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin normal
- •SGOT and SGPT no greater than 1.5 times normal
- •Alkaline phosphatase no greater than 1.5 times normal
- •Creatinine less than 1.5 times normal
- •Cardiovascular:
- •No history of significant angina, congestive heart failure, or myocardial infarction within the past year
- •No clinically significant arrhythmias or uncontrolled hypertension
- •LVEF normal by MUGA, LV gated scan, or echocardiogram
- •No other concurrent serious illness
- •No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Disease-free survival
Incidence of thromboembolic events during the first 9 months after randomization
Overall survival
次要结局
- Tolerability
- Quality of life