NCT00247650已完成2 期
Randomized Multi-Center Study Comparing Prolonged Primary Systemic Endocrine Therapy With Letrozole Alone or in Combination With Zoledronic Acid in Early Breast Cancer (NEOadjuvant Study in CANada)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 190
- 试验地点
- 11
- 主要终点
- Clinical response at 24 weeks
研究概览
简要总结
This study is to measure the extent of tumor shrinkage when Letrozole and Zoledronic Acid are given before surgery to newly diagnosed post-menopausal women with 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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women
- •Newly diagnosed with non metastatic breast cancer
- •Candidate for mastectomy or breast-conserving surgery
排除标准
- •Patients with invasive tumors
- •Patients receiving anti-cancer treatment
- •Patients who have undergone surgery
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Clinical response at 24 weeks
次要结局
- Biomarkers
- Clinical benefit at 16 weeks
- Clinical benefit at 24 weeks
- Rate of breast conserving surgery in both arms
- Clinical response at 16 weeks
- Rate of complete pathological response
研究者
研究点 (11)
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