Prospective Observational Study in Patients With Metastatic Breast Cancer Treated With Anthracyclines
2016年4月22日 更新者：Teva Pharma
Screening and Management of Cardiovascular Risk in Belgian Women Aged > or = 65 Years With Metastatic Breast Cancer Before and After Anthracycline Treatment
This is an open, multicentre, prospective observational (non-interventional) study, performed in Belgium.
Principal objectives:
- To evaluate the prevalence of cardiovascular risk factors and cardiac function (as routinely evaluated) before treatment with anthracyclines of patients with metastatic breast cancer (MBC) aged > or = 65 years
- To observe the management of cardiovascular risk during and after anthracycline treatment
- To compare liposomal versus non-liposomal anthracycline therapy (ratio 1:1) on cardiac function, outcome and quality of life (EORTC QLQ-C30)
Secondary objectives:
- To evaluate the efficacy of anthracyclines on progression free survival and tumor response as routinely measured (e.g. recist criteria, tumor markers and other exams)
- To evaluate cardiovascular event type: ECG changes, arrhythmia, decrease of ejection fraction, heart failure and rate according to allocated treatment.
- To find out how quality of life, e.g. such as described according to EORTC QLQ-C30 criteria or Karnofsky index is achieved in the various patient subgroups
- To correlate the therapeutic choice and posology of anthracyclines for MBC with Cardiovascular risk at baseline
- To calculate the cardiovascular risk according to SCORE
研究概览
地位
完全的
条件
详细说明
The physician will be requested:
- To include 15 consecutive patients aged > or = 65 years who will be treated with anthracyclines in first and second line MBC. The physician will be encouraged to enrol 2 arms of 8 patients (one treated with liposomal and one with non-liposomal anthracyclines) for observation and comparison. Each arm will be closed as soon as 150 patients are included at a national level.
- To report their cardiovascular risk factors
- To provide the results of routinely performed cardiac evaluation before treatment
- To monitor routinely cardiovascular parameters during treatment and report them afterwards
- To monitor efficacy and tolerance of treatments, as normal practice prescribes, reported and related to the variables described in objectives
- To ensure that quality of life will be assessed with the EORTC QLQ-C30 questionnaire
- To monitor and report progression free survival and cardiac events
- To record and transmit spontaneously reported adverse events. These will be handled according to legal requirements
Follow-up will cover a period of 15 months following inclusion.
The study will have 3 visits and 2 contacts:
- One visit at entry
- One visit after 3 cycles of anthracycline containing therapy
- One visit at the end of treatment
- Contact at 9 months after inclusion
- Contact at 15 months after inclusion
It is planned to include data from 15 consecutive female patients per specialized center in Belgium.
The total number of patients aimed is 300.
研究类型
观察性的
注册 (实际的)
60
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
-
-
-
Antwerp、比利时、2020
- ZNA Middelheim
-
Arlon、比利时、6700
- Cliniques du Sud Lux - St Joseph
-
Bonheiden、比利时、2820
- Imelda
-
Bouge、比利时、5004
- Clinique Saint-Luc
-
Brasschaat、比利时、2930
- AZ Klina
-
Brugge、比利时、8000
- AZ St Jan
-
Brussel、比利时、1090
- UZ Brussel
-
Brussels、比利时、1020
- CHU Brugmann
-
Brussels、比利时、1070
- Erasme
-
Brussels、比利时、1180
- CHIREC - Centre Hospitalier Interrégional Edith Cavell
-
Chimay、比利时、6460
- CSF
-
Duffel、比利时、2570
- AZ St-Maarten
-
Edegem、比利时、2650
- UZA
-
Geel、比利时、2440
- AZ St-Dimpna
-
Ghent、比利时、9000
- AZ St-Lucas
-
Merksem、比利时、2170
- ZNA Jan Palfijn
-
Namur、比利时、5000
- CMSE
-
Namur、比利时、5000
- CHR
-
Oostende、比利时、8400
- AZ Damiaan
-
Ottignies、比利时、1340
- Clinique St Pierre
-
St-Niklaas、比利时、9100
- AZ Nikolaas
-
Tournai、比利时、7500
- Centre Hospitalier de Wallonie picarde - site IMC
-
Verviers、比利时、4800
- CHPLT
-
Yvoir、比利时、5530
- CHU Mont-Godinne
-
-
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
65年 及以上 (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
概率样本
研究人群
Belgian women aged > or = 65 years with metastatic breast cancer before and after anthracycline treatment.
Patients will be included in 24 centers specialized in the treatment of breast cancer, in Belgium.
描述
Inclusion Criteria:
- women aged 65 years old or more
- with confirmed metastatic breast cancer (MBC)
- who will be treated with anthracyclines in first or second line
- who have a Karnofsky score at baseline of 50
- who agree and are able to fill in the EORTC QLQ-C30 questionnaire
- who gave their informed consent
Exclusion Criteria:
- women having contra-Indications for anthracyclines
- women aged < 65 years old
- with no metastatic breast cancer
- who will not be eligible for an anthracycline treatment in first or second line MBC
- who have a Karnofsky less than 50
- who disagree or are unable to fill in the EORTC QLQ-C30 questionnaire
- women refusing or not having signed their informed consent
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
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
cardiovascular risk factors
大体时间：15 months
|
15 months
|
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。
赞助
调查人员
- 首席研究员：Christel Fontaine, MD、Universitair Ziekenhuis Brussel
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
2012年2月1日
初级完成 (实际的)
2016年4月1日
研究完成 (实际的)
2016年4月1日
研究注册日期
首次提交
2012年3月14日
首先提交符合 QC 标准的
2012年3月15日
首次发布 (估计)
2012年3月16日
研究记录更新
最后更新发布 (估计)
2016年4月25日
上次提交的符合 QC 标准的更新
2016年4月22日
最后验证
2016年4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.