Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy Plus Bevacizumab in Women With HER2-Negative Metastatic Breast Cancer. An Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as first line treatment of patients with metastatic Breast Cancer.
详细描述
Nowadays in clinical practice patients with previously untreated metastatic breast cancer often receive taxane-based chemotherapy (paclitaxel or docetaxel) in combination with bevacizumab as it has been shown to increase progression-free survival. There is currently minimal information whether bevacizumab should be given as maintenance therapy after discontinuation of chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Written informed consent
- •Age ≥18 years
- •Patients with histologically or cytologically confirmed, HER2-negative, metastatic Breast Cancer
- •No prior first line treatment for metastatic Breast Cancer
- •Previous hormonotherapy for metastatic Breast Cancer is allowed
- •One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
- •ECOG performance status ≤2
- •Adequate haematological, renal and hepatic function
- •Urine protein <2+ (dipstick)
- •Life expectancy of ≥12 weeks
排除标准
- •Previous first line treatment for metastatic colorectal cancer(progression >12 months after the end of adjuvant treatment)
- •Previous radiotherapy to target lesions
- •Patients with brain metastases and/or cancerous meningitis
- •Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
- •Patients participating in interventional clinical trial
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Every 2 or 3 weeks up to 12 or 18 weeks
In this observational study investigators are going to assess standard schedules in which administration was every 2 or 3 weeks
次要结局
- Number of Participants with Response Rate(Disease evaluation at Week 3 or at week 6)
- Percentage of Patients with Progression Free Survival(1 year)
- Patients Overall Survival(1 year)