An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (HERODOT)
2017年5月30日 更新者：Hoffmann-La Roche
Multicenter, Single-Arm, Observational Study of Mean Duration of Trastuzumab (Herceptin) Treatment in Patients With HER2-Positive Early or Metastatic Breast Cancer in Romanian Population
This single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic HER2-positive breast cancer.
Data will be collected from female participants treated with trastuzumab according to the Summary of Product Characteristics and local protocols.
Duration of observation for each participant is from therapy initiation until permanent discontinuation for any cause.
研究概览
研究类型
观察性的
注册 (实际的)
250
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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Cluj-Napoca、罗马尼亚、400006
- Cluj Clinical County Hospital; Oncology Dept
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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
女性
取样方法
非概率样本
研究人群
Female participants with early or metastatic HER2-positive breast cancer
描述
Inclusion Criteria:
- HER2-positive breast cancer
- Treated with trastuzumab in accordance with Summary of Product Characteristics and local protocols
- Written informed consent to data collection
Exclusion Criteria:
- Any contraindication to trastuzumab
- Clinically relevant cardiovascular disorder or disease
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 |
干预/治疗 |
|---|---|
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Participants with Breast Cancer
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, will be observed.
Dosing and treatment duration of the trastuzumab will be at the discretion of the treating physician.
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Trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Treatment Duration With Trastuzumab in the Routine Clinical Practice
大体时间：Baseline up to 5 years
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Baseline up to 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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Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation
大体时间：Baseline up to 5 years
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Baseline up to 5 years
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Percentage of Participants Who Received Previous Neoadjuvant Therapy
大体时间：Baseline up to 5 years
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As a neoadjuvant therapy, participants received chemotherapy alone, radiotherapy alone, hormonal therapy alone or combination of these therapies.
Percentage of participants who received these therapies is reported.
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Baseline up to 5 years
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Percentage of Participants Who Had Surgical Procedure for Breast Cancer
大体时间：Baseline up to 5 years
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Percentage of participants who underwent different types of surgical procedures for breast cancer are reported.
Different types of surgical procedures included: breast-conserving surgery; mastectomy; and other (any other surgical procedure except breast-conserving surgery and mastectomy).
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Baseline up to 5 years
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Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer
大体时间：Baseline up to 5 years
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Baseline up to 5 years
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Progression Free Survival
大体时间：Baseline uo tp 5 years
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Progression free survival was defined as the time from first dose of trastuzumab to disease progression as assessed by treating physician.
Due to observational nature of the study, there was no specific method of assessment used to define progressive disease.
Progressive disease was confirmed by treating physician, based on his/her assessment according to local practice.
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Baseline uo tp 5 years
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Percentage of Participants by the Site of First Disease Progression
大体时间：Baseline up to 5 years
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Baseline up to 5 years
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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 (实际的)
2010年4月14日
初级完成 (实际的)
2015年10月15日
研究完成 (实际的)
2015年10月15日
研究注册日期
首次提交
2010年8月20日
首先提交符合 QC 标准的
2010年8月20日
首次发布 (估计)
2010年8月24日
研究记录更新
最后更新发布 (实际的)
2017年10月20日
上次提交的符合 QC 标准的更新
2017年5月30日
最后验证
2017年5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.