Effects of Identifying and Treating Early, Subclinical Cardiotoxicity on the Long-Term Incidence of Clinical Cardiotoxicity in Women With Breast Cancer, A Prospective Randomized Study: The Cardio-Oncology Breast Cancer Study (COBC)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Event free survival
研究概览
简要总结
The main objective of this randomized controlled trial is to test the association between standard cardiac risk factors, biomarkers and parameters of echocardiography, electrocardiography, and cardiac magnetic resonance imaging, (predictors) and subsequent occurrence, frequency and severity of clinical or subclinical cardiotoxicity (outcome) within and between-groups, before start of chemotherapy, during treatment and at 1, 5, and 10 years after the completion of the chemotherapy among women with early breast cancer.
详细描述
Rationale for the study:
Breast cancer is the most common cancer among Swedish women, accounting for a third of all cancer cases among females. The breast cancer incidence has increased from 2596 to more than 8000 breast cancer diagnosis 2011. During the past 40 years, the age-adjusted incidence has doubled. Early adjuvant therapy reduces the risk of dying with about 50%. (Early adjuvant therapies; chemotherapy, antibodies, endocrine therapy, and radiotherapy). Treatment advances have improved survival rates, but treatment-related cardiotoxicity (CT) remains a substantial problem.
In general, earlier treatment of cardiotoxicity offers the best chances of preventing or ameliorating clinical cardiotoxicity. Risk factors should be modified or reduced by treating elevated blood pressure, normalizing lipids, encouraging weight reduction and smoking cessation. Patient-tailored therapy is now possible, especially given the availability of different chemotherapy regimens, safer anthracycline analogs such as liposomal doxorubicin, and cardioprotective medications such as angiotensin converting enzyme (ACE)-inhibitors, angiotensin receptor blockers, and b-blockers. It is now suggested that new cardiac biomarkers and ultrasound techniques can detect cardiotoxicity in its early, subclinical, stages. The investigators hypothesized that biomarkers can be used to detect subclinical cardiotoxicity and that detecting early signs of cardiotoxicity might reduce the number, time-to-onset, and severity of cardiotoxic events.
In present proposal the investigators aim in a randomized study to compare primary cardiac preventive measurements versus standard care.
Objectives of the trial:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Women with newly diagnosed breast cancer who are eligible to receive neo-adjuvant or adjuvant chemotherapy, with or without trastuzumab, according to the guidelines for breast cancer.
- •Written informed consent must be given.
排除标准
- •A history of heart disease; ischemic heart disease, arrhythmias, heart failure, and valve diseases.
- •Previously received oncological treatment for any malignancy.
- •Other disease or conditions that complicates or precludes the patient from following the study protocol.
研究组 & 干预措施
Observational arm
Participants randomized to observational arm will receive standard oncological followup and care.
Intervention arm
Intervention arm receives standard oncological followup and care + subclinical cardiotoxicity surveillance and treatment.
干预措施: Subclinical cardiotoxicity surveillance and treatment (Other)
结局指标
主要结局
Event free survival
时间窗: 1 year after the completion of the chemotherapy.
The cumulative incidence of clinical or subclinical cardiotoxicity, per randomized arm, in women with breast cancer at 1 year after treatment with neo- or adjuvant chemotherapy.
次要结局
- Event free survival(5 and 10 years after the completion of the chemotherapy.)
- The quality of life(1, 5 and 10 years after the completion of the chemotherapy.)
- Overall survival(1, 5 and 10 years after the completion of the chemotherapy.)
- The levels of serum biomarkers (hs-Troponin T (hs-TnT), B-type natriuretic peptide (BNP)).(1, 5 and 10 years after the completion of the chemotherapy.)
- Echocardiographic global longitudinal strain(1, 5 and 10 years after the completion of the chemotherapy.)
研究者
Elham Hedayati
M.D., Ph.D. Senior Consultant
Karolinska University Hospital
