Breast Cancer Female
Conditions
Keywords
tamoxifen, breast cancer, Z-endoxifen
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
Interventions
OTHERNo intervention
no intervention
Sponsors
Dharmais National Cancer Center Hospital
Trisakti University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Breast cancer patients on tamoxifen treatment for at least 4 months
Exclusion criteria
* Abnormalities in liver markers (AST \>2.5 x ULN)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genotype and phenotype of CYP2D6 | 4 months | Number of subjects with CYP2D6 genotype and phenotype who had steady state level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Z-endoxifen | 4 months | Number of subjects with plasma levels of Z-endoxifen more than 5.9 ng/mL |
Countries
Indonesia
Contacts
Primary ContactYenny, MD
Outcome results
None listed