Tamoxifen Dose Adjustment on ER+ Breast Cancer Patients Based on Genomic and Metabolite Concentrations Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Effects of genotype and phenotype of CYP2D6 on plasma and serum concentration of tamoxifen and its metabolites
研究概览
简要总结
The objectives of this study is to perform CYP2D6 genotyping and metabolite concentrations analysis on ER+ breast cancer patients who are taking tamoxifen and give dose recommendations based on the CYP2D6 genotypes and endoxifen levels.
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
- •Diagnosed with ER+ breast cancer
- •Have taken tamoxifen daily for at least 2 months
排除标准
- •Have not taken tamoxifen daily for at least 2 months
研究组 & 干预措施
Personalized dosing of tamoxifen
Increase tamoxifen dose into 40 mg/day for patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype.
干预措施: Tamoxifen dose adjustment (Drug)
结局指标
主要结局
Effects of genotype and phenotype of CYP2D6 on plasma and serum concentration of tamoxifen and its metabolites
时间窗: 8 weeks after initial tamoxifen intake
Effects of dose recommendation of tamoxifen based on CYP2D6 genotyping results on endoxifen levels
时间窗: 8 weeks after dose recommendation
Frequencies of CYP2D6 alleles in female Indonesian population
时间窗: Baseline, pre-intervention
次要结局
未报告次要终点