NCT01661153已完成不适用
A Non-interventional Study of Avastin in Combination With Paclitaxel for First Line Treatment in HER2 Negative Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
This prospective observational study will evaluate the use in clinical practice, efficacy and safety of Avastin (bevacizumab) in combination with paclitaxel in first line in patients with HER2-negative metastatic breast cancer. Data will be collected from eligible patients for up to 2.5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/= 18 years of age
- •Locally recurrent or metastatic breast cancer
- •No prior treatment for metastatic or locally recurrent disease
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
排除标准
- •History or clinical evidence of brain metastases
- •Pregnancy
- •Uncontrolled hypertension ( systolic > 150 mmHg and/or diastolic > 100 mmHg) or clinically significant (i.e. active) cardiovascular disease
- •Major surgical procedure or significant traumatic injury within 28 days prior to enrolment
结局指标
主要结局
Progression-free survival
时间窗: approximately 2.5 years
次要结局
- Dosage/schedule/number of cycles of Avastin treatment in clinical practice(approximately 2.5 years)
- Safety: Incidence of adverse events(approximately 2.5 years)
研究者
研究点 (2)
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