Pharmacogenetic Dosing of Epirubicin in FEC Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype.
研究概览
简要总结
Epirubicin is a common chemotherapy medication used in the treatment of breast cancer. However, chemotherapy dosing is calculated based on people's height and weight, which may not be the most accurate way. The purpose of this study is to see if epirubicin dosing based on people's genetic profiles is better than the usual methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Female patients with histologically confirmed non-metastatic invasive breast cancer who are scheduled to receive at least three cycles of FEC100 in the adjuvant or neoadjuvant setting
- •Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor [ER], progesterone receptor [PR] and HER-2 status
- •Eastern Cooperative Oncology (ECOG) performance status of ≤ 2
- •A Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
排除标准
- •Uncontrolled congestive heart failure (CHF) or angina, history of myocardial infarction within 2 months before study enrollment, or cardiac functional capacity Class III or IV as defined by the New York Heart Association Classification.
- •Psychiatric disorder(s) that would interfere with consent, study participation, or follow up.
研究组 & 干预措施
Epirubicin
Following genetic analysis, depending on results, participants will receive either standard or increased epirubicin dosing for cycles 2 - 4.
干预措施: Epirubicin (Drug)
结局指标
主要结局
The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype.
时间窗: 10 years
Primary Objectives To describe the side effects of pharmacogenetically individualized FEC chemotherapy in the adjuvant and neoadjuvant treatment of breast cancer.
次要结局
- Secondary Objectives i) To verify relationships between uridine glucuronosyltransferase 2B7 polymorphisms and epirubicin pharmacokinetics ii) To verify relationships between body composition and epirubicin pharmacokinetics(10 years)