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临床试验/NCT01555944
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

Teva Pharma24 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年2月最近更新:
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:

  1. 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
  2. To observe the management of cardiovascular risk during and after anthracycline treatment
  3. To compare liposomal versus non-liposomal anthracycline therapy (ratio 1:1) on cardiac function, outcome and quality of life (EORTC QLQ-C30)

Secondary objectives:

  1. 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)
  2. To evaluate cardiovascular event type: ECG changes, arrhythmia, decrease of ejection fraction, heart failure and rate according to allocated treatment.
  3. 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
  4. To correlate the therapeutic choice and posology of anthracyclines for MBC with Cardiovascular risk at baseline
  5. 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

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

发起方
Teva Pharma
申办方类型
Industry
责任方
Sponsor

研究点 (24)

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