A Large, Uniquely Simple, Randomised Study to Assess Much More Reliably the Balance of Benefits and Risks of Prolonging Adjuvant Tamoxifen Treatment in Early Breast Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 20,000
- 试验地点
- 2
- 主要终点
- 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 blocking the uptake of estrogen by the tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of at least 2 years of tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast cancer that has been surgically removed.
详细描述
OBJECTIVES:
- Compare the disease-free and overall survival of women with early breast cancer who are randomized to discontinue adjuvant tamoxifen vs those randomized to continue for at least 5 additional years.
OUTLINE: This is a randomized study. Patients are stratified for analysis according to duration of tamoxifen given before randomization (2-3 years vs 4-5 years vs 6-7 years vs 8-9 years vs 10 years and over), age (less than 49 vs over 50), and important prognostic factors, including tumor type and grade and nodal and estrogen receptor status. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients discontinue tamoxifen after at least 2 years of prior treatment.
- Arm II: Patients continue treatment with tamoxifen for at least 5 additional years in the absence of unacceptable toxicity or disease progression.
Patients are followed annually.
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 confirmed breast carcinoma that has been completely excised
- •Clinically relapse free
- •Must have completed at least two years of adjuvant therapy with tamoxifen for early breast cancer AND have no clear indication for or against receiving further tamoxifen
- •No significant endometrial hyperplasia
- •No patients with negligibly low risk of breast cancer death
- •Hormone receptor status:
- •Any status allowed
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Menopausal status:
- •Any status allowed
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No other life threatening disease
- •No retinopathy
- •No psychiatric disorder or other condition that would preclude study compliance
- •No serious toxicity (e.g., depression) thought to be due to tamoxifen
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •See Disease Characteristics
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- •Any primary treatment allowed
排除标准
- 未提供
结局指标
主要结局
All-cause mortality
次要结局
- Death due to breast cancer, other primary tumors, or cardiovascular causes
- Disease recurrence