A Phase III Study Comparing Anastrozole, Letrozole and Exemestane, Upfront (for 5 Years) or Sequentially (for 3 Years After 2 Years of Tamoxifen), as Adjuvant Treatment of Postmenopausal Patients With Endocrine-responsive Breast Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 3,697
- 试验地点
- 5
- 主要终点
- Disease-free survival
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking use of estrogen by the tumor cells. Anastrozole, letrozole, and exemestane may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether giving tamoxifen followed by anastrozole, letrozole, or exemestane is more effective than giving anastrozole, letrozole, or exemestane alone in treating breast cancer.
PURPOSE: This randomized phase III trial is studying giving tamoxifen followed by either anastrozole, letrozole, or exemestane to see how well it works compared to anastrozole, letrozole, or exemestane alone in treating postmenopausal women with hormone-responsive invasive breast cancer that has been completely removed by surgery.
详细描述
OBJECTIVES:
- To compare sequential tamoxifen for 2 years followed by anastrozole, letrozole, or exemestane for 3 years vs anastrozole, letrozole, or exemestane for 5 years in terms of disease-free survival in postmenopausal women with nonrecurrent, nonmetastatic invasive endocrine-responsive breast cancer.
- To compare disease-free survival in patients treated with anastrozole vs letrozole vs exemestane.
OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor status (estrogen receptor [ER]-positive and progesterone [PgR] receptor-positive disease vs ER-positive and PgR-negative disease vs ER-negative and PgR-positive disease vs ER- or PgR-positive disease or ER or PgR status unknown), HER-2/neu status (positive [3+ by IHC or positive by fluorescence in situ hybridization ( FISH)] vs negative vs unknown), prior chemotherapy (none vs adjuvant vs neoadjuvant vs both adjuvant and neoadjuvant), and nodal status (pN0 vs pN1 vs pN2 vs pN3). Patients are randomized to 1 of 6 treatment arms.
- Arm I: Patients receive oral anastrozole once daily for 5 years.
- Arm II: Patients receive oral exemestane once daily for 5 years.
- Arm III: Patients receive oral letrozole once daily for 5 years.
- Arm IV: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral anastrazole once daily for 3 years.
- Arm V: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral exemestane once daily for 3 years.
- Arm VI: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral letrozole once daily for 3 years.
Treatment in all arms continues in the absence of disease recurrence or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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
A - anastrozole
Up-front adjuvant anastrozole for 5 years
干预措施: anastrozole (Drug)
B - exemestane
Up-front adjuvant exemestane for 5 years
干预措施: exemestane (Drug)
C - letrozole
Up-front adjuvant letrozole for 5 years
干预措施: letrozole (Drug)
D - tamoxifen followed by anastrozole
Switch adjuvant treatment with tamoxifen for 2 years followed by anastrozole for 3 years
干预措施: anastrozole (Drug)
D - tamoxifen followed by anastrozole
Switch adjuvant treatment with tamoxifen for 2 years followed by anastrozole for 3 years
干预措施: tamoxifen citrate (Drug)
E - tamoxifen followed by exemestane
Switch adjuvant treatment with tamoxifen for 2 years followed by exemestane for 3 years
干预措施: exemestane (Drug)
E - tamoxifen followed by exemestane
Switch adjuvant treatment with tamoxifen for 2 years followed by exemestane for 3 years
干预措施: tamoxifen citrate (Drug)
F - tamoxifen followed by letrozole
Switch adjuvant treatment with tamoxifen for 2 years followed by letrozolefor 3 years
干预措施: letrozole (Drug)
F - tamoxifen followed by letrozole
Switch adjuvant treatment with tamoxifen for 2 years followed by letrozolefor 3 years
干预措施: tamoxifen citrate (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 5 years
次要结局
- Cumulative incidence and type of second non-breast invasive cancer(5 years)
- Toxicity as assessed by NCI CTCAE v3.0(5 years)
- Effects on lipid profile(5 years)
- Cumulative incidence of contralateral breast cancer as first event(5 years)
- Overall Survival(5 years)
- Distant metastasis-free survival(5 years)
- Breast cancer-free survival(5 years)