NCT00333047已完成2 期
A Study of Letrozole in the Treatment of Metastatic Breast Cancer in Combination With Chemotherapy
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
- 24
- 试验地点
- 1
- 主要终点
- Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression
研究概览
简要总结
Therapeutic interventions for patients with metastatic breast cancer are aimed at prolonging survival and improving the quality of life. The objective of this trial is to assess if an initial chemotherapy followed by an endocrine therapy leads to a longer disease-free interval as compared to chemotherapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Histologically proven metastatic breast cancer
- •Measurable disease, patients with bone only disease are not eligible
- •Age ≥ 65 years
- •Performance status ≤ 2 (World Health Organization)
- •Estimated life expectancy under therapy of at least 3 months
- •Estrogen-/progesterone-receptor status positive or unknown
- •Signed informed consent
排除标准
- •Prior chemo- or hormone therapy for metastatic breast cancer; prior therapy with aromatase inhibitors in the adjuvant setting
- •Disease-free interval after adjuvant therapy < 1 year
- •Clinical signs of central nervous system metastases
- •Renal, bone marrow, or liver insufficiency
- •Severe coronary heart disease, cardiac insufficiency or other severe concomitant internal diseases
- •Pulmonary fibrosis/alveolitis Additional protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression
次要结局
- Time to progression and safety and toxicity during treatment
研究者
研究点 (1)
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