NCT00717015已完成不适用
Tamoxifen Pharmacokinetics and CYP2D6 Polymorphisms in Asian Women With Hormone Receptor Positive Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of tamoxifen and its metabolites in hormone receptor positive women who are taking tamoxifen as adjuvant treatment for breast cancer.
研究概览
简要总结
We hypothesized that subjects with CYP2D6*10 alleles may have a lower steady state levels of endoxifen due to reduced conversion of tamoxifen to endoxifen.
Primary objectives:
- To determine the steady state pharmacokinetics of tamoxifen and its metabolites
- To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of tamoxifen and its metabolites in hormone receptor positive women who are taking tamoxifen as adjuvant treatment for breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
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
- •Signed informed consent.
- •At least 18 years of age.
- •On tamoxifen for at least 3 months for adjuvant therapy.
- •On a stable diet for past 1 week before blood sampling.
- •Compliant with tamoxifen medication.
- •Completed adjuvant chemotherapy and/or adjuvant radiation therapy.
排除标准
- •Patients should not be on the list of medications for the last 1 week before accrual to the study
结局指标
主要结局
To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of tamoxifen and its metabolites in hormone receptor positive women who are taking tamoxifen as adjuvant treatment for breast cancer.
To determine the steady state pharmacokinetics of tamoxifen and its metabolites
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
The Clinical and Economic Impact of Pharmacogenomic Testing for Tamoxifen Metabolism in Postmenopausal Women Receiving Tamoxifen for Prevention of Recurrent Breast CancerBreast NeoplasmsTamoxifenNCT00830973Medco Health Solutions, Inc.184
已完成
不适用
Study of Cytochrome P450 Polymorphisms (CYP2D6, CYP3A4/5 and CYP2C19) in Breast Cancer PatientsBreast NeoplasmsSurvival AnalysisAntineoplastic AgentsTherapeutic UsesNCT01169792Yonsei University
已完成
不适用
Tamoxifen Dose Adjustment on Indonesian Female ER+ Breast Cancer Patients Based on CYP2D6 Genotype and Endoxifen LevelsER+ Breast CancerNCT04312347Nalagenetics Pte Ltd151
Unknown
不适用
CYP2D6 Genotyping by AmpliChipTM CYP450 for Tamoxifen-Treated Breast Cancer PatientsBreast CancerNCT00815555Assaf-Harofeh Medical Center500
Unknown
1 期
Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-infected Thai PatientsCytochrome P-450 CYP2B6EfavirenzHIVNCT02421289Mahidol University190