Genotyping and Phenotyping of CYP2D6 as Predictor of Z-endoxifen Plasma Levels in Breast Cancer Patients on Tamoxifen Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Genotype and phenotype of CYP2D6
研究概览
简要总结
This study is an observational study to determine phenotype and genotype of CYP2D6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months
详细描述
Tamoxifen is an antiestrogen drug with concentration dependent properties, with z-endoxifen known as active metabolite. Until know therapeutic range for z-endoxifen to improve treatment response was not known. Variation response on tamoxifen can be cause of genetic polymorphism CYP2D6 that can be different between interindividul and ethnic.
The aim of this study is to determine phenotype and genotype of CYP2D6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients on tamoxifen treatment for at least 4 months
排除标准
- •Abnormalities in liver markers (AST >2.5 x ULN)
结局指标
主要结局
Genotype and phenotype of CYP2D6
时间窗: 4 months
Number of subjects with CYP2D6 genotype and phenotype who had steady state level
次要结局
- Z-endoxifen(4 months)
研究者
Yenny Farmako
Head of Pharmacology
Trisakti University