A Prospective Study to See if Cardiac Effects of Herceptin Can be Prevented With Standard Heart Medications
试验速览
- 阶段
- 1 期
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- The primary objective is to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular (LV) remodeling among women with HER2+ early breast cancer.
研究概览
简要总结
While trastuzumab has been shown to prevent recurrences of breast cancer, some women may also experience damage to their heart muscle (including heart failure) as a result of their treatment. The investigators hope to learn if standard medications used in heart failure can prevent heart damage caused by trastuzumab in women with breast cancer. The investigators would also like to know if there are any ways to detect this damage earlier using magnetic resonance imaging (MRI) and blood tests.
详细描述
We propose a randomized, placebo-controlled, double-blind study evaluating the efficacy of an ACE-inhibitor (perindopril) or a beta blocker (bisoprolol) for the prevention of LV remodeling among women with early breast cancer scheduled for chemotherapy and one year of trastuzumab. Participants will undergo cardiac MRI at baseline and 3 and 12 months, replacing the usual MUGA, as well as a post-treatment cardiac MRI at 24 months to evaluate long-term effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of HER2 positive breast carcinoma
- •Eligible to receive trastuzumab
- •Age > 18 years
- •Able to give informed consent
- •No contraindications to MRI
排除标准
- •Known contraindication to beta-blocker therapy
- •Known contraindication to ACEI therapy
- •Current treatment with ACEI or beta blocker for other indication
- •History of heart failure, cardiomyopathy or baseline LVEF < 50%
研究组 & 干预措施
1
干预措施: perindopril OR bisoprolol OR placebo (Drug)
结局指标
主要结局
The primary objective is to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular (LV) remodeling among women with HER2+ early breast cancer.
时间窗: 3.5 years
次要结局
未报告次要终点