Genotyping and Phenotyping of CYP2D6 Breast Cancer Patients on Tamoxifen

Trisakti University

Status: Unknown

Conditions: Breast Cancer Female

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03504631

1001

Details and patient eligibility

About

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

Full 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

Enrollment: 117 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

117 participants in 1 patient group

Breast cancer patients on tamoxifen

Description:

Patients currently on treatment with tamoxifen for at least 4 months.

Treatment:

Other: No intervention