A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,966
- 试验地点
- 800
- 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 letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine whether or not prolonged adjuvant hormonal therapy comprising letrozole vs placebo will improve disease-free survival of postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive breast cancer who have completed 5 years of hormonal therapy with 5 years of an aromatase inhibitor (AI) or 5 years of a combination of up to 3 years of tamoxifen citrate followed by an AI.
- Compare the disease-free survival of patients treated with these regimens.
Secondary
- Compare overall survival of patients treated with these regimens.
- Compare breast cancer-free interval of patients treated with these regimens.
- Compare distant recurrence in patients treated with these regimens.
- Compare the incidence of osteoporotic-related fractures (e.g., Colles', hip, and spine) in these patients treated with these regimens.
- Compare the incidence of arterial thrombotic events in patients treated with these regimens.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 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
Group 2 Letrozole
Patients receive oral letrozole once daily for up to 5 years.
干预措施: Letrozole (Drug)
Group 1 Placebo
Patients receive oral placebo once daily for up to 5 years.
干预措施: Placebo (Other)
结局指标
主要结局
Disease-free Survival
时间窗: 7 years.
Percentage of patients free from DFS events. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer.
次要结局
- Breast Cancer-free Interval(7 years)
- Arterial Thrombotic Events(7 years)
- Overall Survival(7 years)
- Osteoporotic-related Fractures(7 years)
- Distant Recurrence(7 years)