A Study to Evaluate the Effect of Letrozole and Tamoxifen on Bone and Lipids in Postmenopausal Women With Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)
研究概览
简要总结
Estrogen is known to be a regulator of bone and lipid metabolism. Letrozole is a potent inhibitor of estrogen synthesis.
This study evaluated the effects of letrozole and tamoxifen on bone and lipid metabolism in postmenopausal women with resected, receptor positive early breast cancer.
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
- None
入排标准
- 年龄范围
- 50 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
Letrozole
2.5 mg once daily (q.d.)orally for 5 years
干预措施: Letrozole (Drug)
Tam-Let
20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
干预措施: Letrozole (Drug)
Tam-Let
20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)
时间窗: Baseline, 24 months
Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.
次要结局
- Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine(Baseline, 60 months)
- Median Percent Change From Baseline of Serum Markers of Bone Turnover(Baseline, 60 months)
- Percentage Change From Baseline in Serum Lipids at 5 Years(Baseline, 60 months)
- Number of Participants With Clinically Relevant Changes From Baseline in Cholesterol(Baseline, 60 months)
- Time to Disease Recurrence or Death(60 months)
- Time to Overall Survival Events(60 Months)
- Percent Change From Baseline of Bone Mineral Density (BMD) of Total Hip(Baseline, 60 months)