Genotyping and Phenotyping of CYP2D6 Breast Cancer Patients on Tamoxifen

• Conditions: Breast Cancer Female

• 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

Study Timeline

• Study Start: 2017-10-01
• Status Verified: 2018-04
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-20
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-24
• Primary Completion: 2018-10-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 117

Inclusion Criteria

• Breast cancer patients on tamoxifen treatment for at least 4 months

Exclusion Criteria

• Abnormalities in liver markers (AST >2.5 x ULN)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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