NCT01555944已完成不适用
Screening and Management of Cardiovascular Risk in Belgian Women Aged > or = 65 Years With Metastatic Breast Cancer Before and After Anthracycline Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Teva Pharma
- 入组人数
- 60
- 试验地点
- 24
- 主要终点
- cardiovascular risk factors
研究概览
简要总结
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
详细描述
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
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
- 65 Years 至 —(Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
cardiovascular risk factors
时间窗: 15 months
次要结局
未报告次要终点
研究者
研究点 (24)
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