Genotyping and Phenotyping of CYP2D6 Breast Cancer Patients on Tamoxifen
- Conditions
- Breast Cancer Female
- Interventions
- Other: No intervention
- Registration Number
- NCT03504631
- Lead Sponsor
- Trisakti University
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 117
- Breast cancer patients on tamoxifen treatment for at least 4 months
- Abnormalities in liver markers (AST >2.5 x ULN)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Breast cancer patients on tamoxifen No intervention Patients currently on treatment with tamoxifen for at least 4 months.
- Primary Outcome Measures
Name Time Method Genotype and phenotype of CYP2D6 4 months Number of subjects with CYP2D6 genotype and phenotype who had steady state level
- Secondary Outcome Measures
Name Time Method Z-endoxifen 4 months Number of subjects with plasma levels of Z-endoxifen more than 5.9 ng/mL
Trial Locations
- Locations (1)
Dharmais hospital
🇮🇩Jakarta, DKI Jakarta, Indonesia