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临床试验/NCT00858039
NCT00858039已完成不适用

Prediction of Cardiotoxicity Using Serum N-terminal Pro-B-type Natriuretic Peptide in Breast Cancer Patients Receiving Adjuvant Trastuzumab

Royal Prince Alfred Hospital, Sydney, Australia15 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2009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
入组人数
220
试验地点
15
主要终点
Cardiotoxicity (Cardiac death; grade 3/4 arrhythmia or ischaemia; NYHA Class 3 or 4 heart failure decline in LVEF by >10% to a level <55%; decline in LVEF by >5% to a level <50%)

研究概览

简要总结

Trastuzumab (Herceptin®) increases the chances of cure in patients with Her-2 overexpressing early breast cancer. Unfortunately, both the chemotherapy drugs used in this setting (anthracyclines) and trastuzumab are known to cause cardiac dysfunction in a proportion of patients. Patients who develop heart problems when taking trastuzumab might have to stop this treatment, which could jeopardise their chances of cure. N-terminal pro-B-type natriuretic peptide (NT pro-BNP) is a cardiac biomarker that is measured in the blood, the levels of which have been shown to indicate the presence of heart failure. Some early research has suggested that there may be a correlation between elevated NT pro-BNP and heart damage due to cancer chemotherapy and also trastuzumab. Troponin is another substance measured in the blood that can indicate heart damage. Finally, certain variations in an individual's genetic makeup (called polymorphisms) could put them at increased risk of heart damage from trastuzumab. Here we are studying whether any of these factors (NT pro-BNP levels, troponin levels, or certain genetic polymorphisms) can accurately predict who is at highest risk of trastuzumab-related cardiotoxicity.

The principal aim of this study is to evaluate the utility of NT pro-BNP as a predictive biomarker for the development of trastuzumab related cardiotoxicity (TRC). The investigators will also examine if single nucleotide polymorphisms in the HER2 gene or Fc-gamma-receptor genes predict for TRC.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female 18 years or older
  • Histologically confirmed, completely excised invasive breast cancer with Her-2 overexpression
  • Primary surgery less than twelve weeks prior to registration
  • LVEF>50% as assessed by transthoracic echocardiogram or gated heart pool scan
  • Eastern Cooperative Oncology Group Performance Status 0-2
  • Adjuvant systemic treatment plan comprises at least three cycles of anthracycline chemotherapy AND 52 weeks of trastuzumab
  • Before patient registration, informed consent must be given according to local regulations.

排除标准

  • Pregnancy
  • Distant metastases from breast cancer
  • Any systemic chemotherapy prior to study entry

结局指标

主要结局

Cardiotoxicity (Cardiac death; grade 3/4 arrhythmia or ischaemia; NYHA Class 3 or 4 heart failure decline in LVEF by >10% to a level <55%; decline in LVEF by >5% to a level <50%)

时间窗: Until 6 months after completing trastuzumab

次要结局

未报告次要终点

研究者

发起方
Royal Prince Alfred Hospital, Sydney, Australia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shom Goel

Breast Oncology Fellow

Royal Prince Alfred Hospital, Sydney, Australia

研究点 (15)

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