Phase II Placebo-controlled Trial of Lisinopril and Coreg CR® to Reduce Cardiotoxicity in Patients With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy With Trastuzumab (Herceptin®)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 468
- 试验地点
- 174
- 主要终点
- Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment
研究概览
简要总结
RATIONALE: Lisinopril or Coreg CR®, may help reduce side effects caused by trastuzumab. It is not yet known whether lisinopril or Coreg CR® are more effective than a placebo in reducing side effects caused by trastuzumab.
PURPOSE: This phase II trial is studying lisinopril and Coreg CR® to see how well they work compared with a placebo in reducing side effects in patients with HER2-positive breast cancer receiving trastuzumab.
详细描述
OBJECTIVES:
Primary
- The primary objective of this study is to determine if administration of lisinopril or Coreg CR®, compared to placebo, will reduce the incidence of trastuzumab-induced cardiotoxicity, as measured by LVEF, in patients receiving adjuvant, or neoadjuvant,therapy for HER2 positive breast cancer.
Secondary
- To determine whether subjects randomized to active agent have fewer interruptions in trastuzumab therapy due to cardiomyopathy.
- To determine whether the treatment effect is consistent in anthracycline and nonanthracycline patient cohorts
- To compare changes in HRQL among the treatment groups during the study intervention
- To evaluate the long term effects on the prevention of cardiomyopathy and impact on HRQL for either or both study agents
- To compare the predictive value of troponin I and BNP in the identification of trastuzumab-induced cardiotoxicity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I lisinopril
Patients receive oral lisinopril once daily.
干预措施: lisinopril (Drug)
Arm II Coreg CR®
Patients receive oral Coreg CR® once daily.
干预措施: Coreg CR® (Drug)
Arm III placebo
Patients receive oral placebo once daily.
干预措施: placebo (Other)
结局指标
主要结局
Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment
时间窗: 2 years
Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of Left Ventricular Ejection Fraction (LVEF). Number of Patients who experienced a cardiotoxicity.
Number of Participants With LVEF Decrease to <50%
时间窗: 2 years
Number of Participants with Left Ventricular Ejection Fraction (LVEF) drop to \<50%
次要结局
- Number of Patients With Trastuzumab Course Interruption(2 years)
- Quality-of-life Changes Between Baseline and 52-weeks(52 weeks)
- Number of Participants With Cardiotoxicity-free Survival at 750 Days From Baseline(2 years)