NCT00329940已完成3 期
Assessment of Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer Having Discontinued Anastrozole Adjuvant Treatment Due to Musculoskeletal Disorders
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To evaluate the rheumatological tolerability of letrozole 2.5 mg/day in patients treated with anastrozole 1 mg/day
研究概览
简要总结
The purpose of this study is to assess rheumatologic tolerability of letrozole in postmenopausal patients with hormone receptor positive breast cancer having discontinued anastrozole adjuvant treatment due to musculoskeletal disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Postmenopausal women receiving anastrozole adjuvant therapy for hormone receptor positive breast cancer who want to interrupt the treatment because of severe rheumatologic adverse events
- •Polymorphonuclear neutrophils (PNN) ≥ 1200/mm3, platelets ≥ 100000/mm3, hemoglobin (Hb) ≥ 10 g/dL
- •Bilirubin ≤ 30 μmol, SGOT/SGPT < 3N
- •Fully signed informed consent
排除标准
- •Pain due to bone fracture
- •Metastatic disease
- •Hormone therapy other than anastrozole
- •Incapacitating or uncontrolled concomitant disease that could hamper patient's quality of life
- •Hypersensitivity to letrozole or its components
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Letrozole
Experimental
to evaluate the rheumatological tolerability of Femara
干预措施: Letrozole (Drug)
结局指标
主要结局
To evaluate the rheumatological tolerability of letrozole 2.5 mg/day in patients treated with anastrozole 1 mg/day
时间窗: at 1, 3 and 6 months of letrozole treatment
次要结局
- To determine how long letrozole treatment is maintained(at 1, 3 and 6 months of letrozole treatment)
- To determine the causes of discontinuation(at 1, 3 and 6 months of letrozole treatment)
研究者
研究点 (1)
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