AVAREG Study: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer
2016年1月7日 更新者：Hoffmann-La Roche
A Multicenter, Single-arm, Observational Study Describing the Clinical Benefits of Bevacizumab (Avastin) Treatment in Patients With Metastatic Breast Cancer (AVAREG Study)
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.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
220
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Budapest、匈牙利、1115
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Budapest、匈牙利、1125
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Budapest、匈牙利、1122
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Budapest、匈牙利、1135
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Budapest、匈牙利、1145
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Budapest、匈牙利、1088
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Budapest、匈牙利、1082
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Budapest、匈牙利、1106
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Budapest、匈牙利、1097
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Budapest、匈牙利、1076
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Budapest、匈牙利、1031
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Debrecen、匈牙利、4012
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Debrecen、匈牙利、H-4031
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Eger、匈牙利、3300
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Gyor、匈牙利、9023
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Gyula、匈牙利、5700
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Kaposvar、匈牙利、7400
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Kecskemet、匈牙利、6000
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Kistarcsa、匈牙利、2143
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Miskolc、匈牙利、3526
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Nyíregyháza、匈牙利、4400
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Pecs、匈牙利、7624
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Salgótarján、匈牙利、3100
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Szeged、匈牙利、6720
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Szekesfehervar、匈牙利、8000
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Szekszard、匈牙利、7100
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Szentes、匈牙利、6600
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Szolnok、匈牙利、5004
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Szombathely、匈牙利、9700
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Tatabánya、匈牙利、2800
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Veszprem、匈牙利、8200
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Zalaegerszeg、匈牙利、8900
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Patients with metastatic breast cancer initiated on treatment with Avastin in combination with paclitaxel
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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队列
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Progression Free Survival
大体时间：Approximately 5 years
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Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment.
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Approximately 5 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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One Year Survival
大体时间：Approximately 5 years
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The status of participants whether alive, dead, unknown or missing one year after the start of bevacizumab treatment is reported.
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Approximately 5 years
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Time to Discontinuation (TTD) of Bevacizumab Treatment
大体时间：Approximately 5 years
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Time to treatment discontinuation is defined as the time to change of therapy due to any cause (tumour progression, toxicity, or other causes) from the start of bevacizumab treatment.
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Approximately 5 years
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Participants With Hormone Receptor Status at Diagnosis
大体时间：Baseline (Day 1)
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The hormone receptor status for Oestrogen (ER), Progesterone (PgR) and Human epidermal growth factor receptor (HER-2) is reported as positive, negative, unknown or missing.
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Baseline (Day 1)
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Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry
大体时间：Approximately 5 years
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PFS was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment for participants with triple negative status and not triple negative status.
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Approximately 5 years
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Participants With Tumor Stage at Diagnosis
大体时间：Baseline (Day 1)
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Number of participants at each Metastatic breast cancer stage 0, I, II, III or IV, at the point of diagnosis is reported.
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Baseline (Day 1)
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Participants With Eastern Cooperative Oncology Group Status at Study Entry
大体时间：Baseline (Day 1)
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The Eastern Cooperative Oncology Group (ECOG) status for participants was categorized as 0, 1, 2, or missing.
ECOG has 4 grades as: 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities.
Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care, totally confined to bed/chair.
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Baseline (Day 1)
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Participants With Prior Therapy at Study Entry (Baseline)
大体时间：Baseline (Day 1)
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The status of prior therapy (i.e.
chemotherapy, endocrine therapy, and radiotherapy) at study entry (baseline) is reported.
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Baseline (Day 1)
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Participants With Disease History at Study Entry (Baseline)
大体时间：Baseline (Day 1)
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Participant's history at the time of diagnosis of metastatic disease and sites of metastases is reported at study entry (baseline).
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Baseline (Day 1)
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Participants With Type of Metastases at Study Entry (Baseline)
大体时间：Baseline (Day 1)
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The type of metastases (bone and visceral) are reported at study entry (baseline) is reported.
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Baseline (Day 1)
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Participants With Proteinuria at Study Entry (Baseline)
大体时间：Baseline (Day 1)
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The number of participants with proteinurea status as positive, negative or missing is reported.
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Baseline (Day 1)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年12月1日
初级完成 (实际的)
2012年3月1日
研究完成 (实际的)
2012年3月1日
研究注册日期
首次提交
2013年1月24日
首先提交符合 QC 标准的
2013年1月25日
首次发布 (估计)
2013年1月29日
研究记录更新
最后更新发布 (估计)
2016年2月5日
上次提交的符合 QC 标准的更新
2016年1月7日
最后验证
2016年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.