NCT01777932已完成不适用
A Multicenter, Single-arm, Observational Study Describing the Clinical Benefits of Bevacizumab (Avastin) Treatment in Patients With Metastatic Breast Cancer (AVAREG Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 主要终点
- Progression Free Survival
研究概览
简要总结
This multicenter, single-arm observational study will evaluate the clinical benefits of Avastin (bevacizumab) in combination with paclitaxel in first-line treatment in patients with metastatic breast cancer. Patients with metastatic breast cancer who have started Avastin treatment within 6 months prior to study start will also be eligible. Data will be collected from patients for up to 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
- •Patients with metastatic breast cancer initiated on first-line treatment with Avastin in combination with paclitaxel according to the current Hungarian summary of Product Characteristics
- •Patients with metastatic breast cancer initiated within 6 months before the start of the study on treatment with Avastin according to the current Hungarian Summary of Product Characteristics
排除标准
- •Contraindications for Avastin according to the current Hungarian Summary of Product Characteristics:
- •Hypersensitivity to active ingredient of Avastin or to any excipients
- •Hypersensitivity to products produced in Chinese hamster cells or to other recombinant or humanized antibodies
- •Pregnancy
- •Untreated central nervous system metastases
结局指标
主要结局
Progression Free Survival
时间窗: Approximately 5 years
Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment.
次要结局
- Time to Discontinuation (TTD) of Bevacizumab Treatment(Approximately 5 years)
- Participants With Hormone Receptor Status at Diagnosis(Baseline (Day 1))
- Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry(Approximately 5 years)
- Participants With Prior Therapy at Study Entry (Baseline)(Baseline (Day 1))
- Participants With Proteinuria at Study Entry (Baseline)(Baseline (Day 1))
- Participants With Type of Metastases at Study Entry (Baseline)(Baseline (Day 1))
- One Year Survival(Approximately 5 years)
- Participants With Tumor Stage at Diagnosis(Baseline (Day 1))
- Participants With Eastern Cooperative Oncology Group Status at Study Entry(Baseline (Day 1))
- Participants With Disease History at Study Entry (Baseline)(Baseline (Day 1))
研究者
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