A Feasibility Study for Women Receiving Adjuvant or Neo-adjuvant Anthracycline Chemotherapy With or Without Radiation for HER2-neu Positive Invasive Ductal Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Recruitment rates
研究概览
简要总结
The purpose of this project is to assess the feasibility of collecting plasma samples for cardiac biomarker assessment, and to identify if there is an associations between the biomarkers, echocardiographic features and the cardiac PET scan results (in patients receiving radiation therapy). This is the first step in a research program that has an overall goal of being able to predict early-treatment induced cardiotoxicity in patients with breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage I-III, HER2-neu positive invasive ductal carcinoma
- •Scheduled to receive adjuvant/neo-adjuvant 5-Fluorouracil, Epirubicin, Cyclophosphamide and Docetaxel (FEC-D) chemotherapy
- •Scheduled to receive adjuvant Trastuzumab
- •ECOG Performance status 0-2
- •Adequate baseline imaging on transthoracic echocardiography, and baseline cardiac ejection fraction of ≥ 55%. Additionally, breast cancer patients≥45 years of age and scheduled to receive whole breast radiation therapy will receive two cardiac PET scans.
排除标准
- •Prior anthracycline chemotherapy
- •History of dilated cardiomyopathy, congestive heart failure, or coronary artery disease
- •Life expectancy less than 15 months
- •Pregnant or lactating women
- •Use of beta receptor antagonists, calcium channel antagonists, angiotensin converting enzyme inhibitors, or angiotensin receptor inhibitors at baseline.
- •Previous chest wall/breast or nodal radiation.
研究组 & 干预措施
Feasibility study
All participants will have blood draws for biomarkers during the course of the study at visit 1, 2, 3, 4, 5, 6, 7 and 8. they will also have the speckle tracking echocardiogram at visit 1, 4, 5, 6, 7 and 8. For women 45 an over a cardiac PET scan will be performed at visit 1 and 5.
干预措施: Feasibility study (Other)
结局指标
主要结局
Recruitment rates
时间窗: every 4 weeks up to 2 years
次要结局
- Cardiotoxicity(Once when the last participant completes week 57)