Monitoring Heart Function Through Blood Test Analysis of NT-proBNP During Treatment With HER2-Targeted Antibodies in HER2-Positive Breast Cancer - A Swedish Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of NT-proBNP to detect trastuzumab-induced cardiotoxicity
研究概览
简要总结
Trastuzumab-induced cardiotoxicity (TIC) will be monitored in patients with HER2+ breast cancer undergoing trastuzumab treatment before and after breast cancer surgery. At baseline before start of trastuzumab treatment, echocardiography (ECHO)/multigated Acquisition Scan (MUGA) and measurement of plasma NT-proBNP will be performed. NT-proBNP will be measured again at 6 months and at 12 months of trastuzumab treatment. If elevations in NT-proBNP at 6 months and 12 months occur patients will be referred for ECHO/MUGA. The aim is to assess the sensitivity and specificity to detect TIC with NT-proBNP and whether ECHO/MUGA can be safely replaced by assessment of plasma NT-proBNP levels.
详细描述
Sponsor: Swedish Association of Breast Oncologists (SABO), Clinical Trial Unit, Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Design:This is an national multicentre single arm phase II trial for patients with primary HER2 positive breast cancer planned for neoadjuvant/adjuvant treatment with HER2 blocking agents.
Purpose: The purpose of this study is to assess the sensitivity and specificity of NT-proBNP for detection of cardiac failure in patients with primary breast cancer that receive neoadjuvant/adjuvant treatment with HER2 blocking compounds.
Background: Patients with HER2 positive breast cancer > 20 mm and/or with lymph node metastasis receive, according to the national guidelines 4 courses of double antibody blockade with trastuzumab and pertuzumab plus a taxane for 12 weeks followed by EC (epirubicin/cyclophosphamide) every 3rd week times 3 in the neoadjuvant setting followed by continued HER2 blockade with trastuzumab or TDM-1 for a total of 17 courses. Patients with tumours < 20 mm and node-negative disease start with surgery followed by adjuvant treatment with EC x 4 followed by trastuzumab and a taxane for 12 weeks, thereafter trastuzumab x 13 is given as a single agent. For patients with tumours < 10 mm and node negative it is considered sufficient to give only a taxane plus trastuzumab for 12 weeks followed by trastuzumab times 13. The latter less toxic regimen has also been used in elderly fragile patients.
The risk of cardiac dysfunction as determined by a reduction in the Left Ventricular Ejection Fraction (LVEF) below 50% has been estimated to approximately 3-4% in the large registration trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Histological confirmed HER2 positive primary BC planned for adjuvant/neoadjuvant treatment with chemotherapy plus HER2 blocking agents.
- •Patients ≥18 years
- •ECOG/WHO 0-1
- •Adequate organ function for the planned treatment according to local guidelines.
- •No distant metastasis (CT/MRI only if clinically indicated).
- •Negative pregnancy test within 14 days prior to start of treatment.
- •If of childbearing potential, willing to use an effective form of contraception.
- •No other malignancy during the last 5 years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix.
- •Signed informed consent and willingness to follow the trial procedures.
排除标准
- •Patients with previous heart disease recommended special follow-up during treatment with high risk of termination of treatment.
- •Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.
- •Pregnancy and breast feeding.
- •Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
结局指标
主要结局
Sensitivity and specificity of NT-proBNP to detect trastuzumab-induced cardiotoxicity
时间窗: From inclusion to 24 months after baseline investigation
To determine the sensitivity and specificity of NT-proBNP for identification of patients that develop cardiac toxicity during treatment with HER2 blocking agents for primary breast cancer \[time frame from inclusion to 24 months after base-line investigation\]
次要结局
- Anthracycline-induced change in NT-proBNP(From inclusion to 10 weeks after baseline investigation)
- Prevalence of trastuzumab-induced cardiotoxicity(From inclusion to 24 months after baseline investigation)