NCT02424682已完成不适用
Safety of Herceptin in Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- Percentage of Participants with Serious Adverse Events (SAEs)
研究概览
简要总结
This study was designed to evaluate safety and tolerability of Herceptin as treatment for patients with human epidermal growth factor receptor 2 (HER-2) positive metastatic breast cancer. Frequency, characteristics and severity of adverse events (AE) and serious adverse events (SAE) were followed to evaluate the safety of Herceptin in patients with HER2 positive metastatic breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Confirmed diagnosis of metastatic breast cancer (BC) with HER2-neu overexpression
- •Left Ventricular Ejection Fraction (LVEF) by ECHO or Multi Gated Acquisition Scan (MUGA) > 50%
- •Good performance status: Eastern Cooperative Oncology Group (ECOG) scale < or = 2 and life expectancy > or = 12 weeks
排除标准
- •Advanced pulmonary disease and severe dyspnea
- •Abnormal laboratory within 14 days prior to registration
- •Peripheral neuropathy > grade 2
- •Presence of central nervous system (CNS) metastasis
- •Pregnancy or lactating
结局指标
主要结局
Percentage of Participants with Serious Adverse Events (SAEs)
时间窗: Up to 2 years
Percentage of Deaths
时间窗: Up to 2 years
Percentage of Participants with Adverse Events (AEs)
时间窗: Up to 2 years
次要结局
- Percentage of Participants with Serious Adverse Events (SAEs), Who Experienced Progression of Disease(Up to 2 years)
研究者
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