A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8,028
- 试验地点
- 3
- 主要终点
- Disease free survival.
研究概览
简要总结
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. If is not yet known which treatment regimen is most effective for breast cancer.
PURPOSE: Randomized double-blind phase III trial to compare the effectiveness of letrozole with that of tamoxifen in treating postmenopausal women who have breast cancer that has been surgically removed.
详细描述
OBJECTIVES:
- Compare adjuvant letrozole vs tamoxifen administered for 5 years in postmenopausal women with operable, hormone receptor-positive breast cancer.
- Compare these treatment regimens given sequentially vs continuously in this patient population.
- Compare these treatment regimens in terms of overall survival, disease-free and systemic-free survival, safety, and tolerability in this patient population.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to adjuvant chemotherapy (prior therapy vs no prior or concurrent therapy vs concurrent therapy), prior surgery (modified radical mastectomy vs a lesser surgical procedure), and participating center. Patients are randomized to one of four treatment arms.
- Arm I: Patients receive adjuvant oral tamoxifen daily for 5 years.
- Arm II: Patients receive adjuvant oral letrozole daily for 5 years.
- Arm III: Patients receive adjuvant oral tamoxifen daily for 2 years followed by adjuvant oral letrozole daily for 3 years.
- Arm IV: Patients receive adjuvant oral letrozole daily for 2 years followed by adjuvant oral tamoxifen daily for 3 years.
Patients may receive concurrent radiotherapy. Some patients receive concurrent adjuvant chemotherapy beginning within 8 weeks after surgery and continuing for no more than 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tamoxifen
Tamoxifen for 5 years after randomization.
干预措施: tamoxifen citrate (Drug)
Letrozole
Letrozole for 5 years after randomization.
干预措施: letrozole (Drug)
Tamoxifen, then letrozole
Tamoxifen for 2 years after randomization, then letrozole for the next 3 years.
干预措施: letrozole (Drug)
Tamoxifen, then letrozole
Tamoxifen for 2 years after randomization, then letrozole for the next 3 years.
干预措施: tamoxifen citrate (Drug)
Letrozole, then tamoxifen
Letrozole for 2 years after randomization, then tamoxifen for the next 3 years.
干预措施: letrozole (Drug)
Letrozole, then tamoxifen
Letrozole for 2 years after randomization, then tamoxifen for the next 3 years.
干预措施: tamoxifen citrate (Drug)
结局指标
主要结局
Disease free survival.
时间窗: Up to end of year 2015
Time from randomization to recurrence (including recurrence restricted to the breast after breast conserving treatment), metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to end of year 2015, for a maximum of 17 years
次要结局
- Systemic relapse(Up to end of year 2015)
- Overall survival(Up to end of year 2015)
- Safety(5 years after randomization.)