Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study
试验速览
- 阶段
- 3 期
- 入组人数
- 20,000
- 试验地点
- 2
- 主要终点
- Overall survival (i.e., all-cause mortality)
研究概览
简要总结
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer.
PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor removed.
详细描述
OBJECTIVES:
- Assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least 5 years in patients with curatively treated breast cancer who have already had about 5 years of adjuvant tamoxifen.
OUTLINE: This is a randomized study. After about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years.
Patients are followed annually.
PROJECTED ACCRUAL: Approximately 20,000 patients will be accrued for this study.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Curatively treated carcinoma of the breast
- •Currently taking adjuvant tamoxifen
- •Must be substantial uncertainty as to whether or not to continue tamoxifen (i.e., no clear indication or definite contraindication to further treatment with tamoxifen)
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •No contraindications to receiving tamoxifen
- •No other serious medical problems
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior biologic therapy allowed
- •Chemotherapy:
- •Prior chemotherapy allowed
- •Endocrine therapy:
- •See Disease Characteristics
- •Radiotherapy:
- •Prior radiotherapy allowed
- •Prior surgery allowed
排除标准
- 未提供
结局指标
主要结局
Overall survival (i.e., all-cause mortality)
次要结局
- Specific-cause mortality
- Incidence of second primary tumors