Clinical trial NCT03504631: Genotyping and Phenotyping of CYP2D6 Breast Cancer Patients on Tamoxifen
Official title: Genotyping and Phenotyping of CYP2D6 as Predictor of Z-endoxifen Plasma Levels in Breast Cancer Patients on Tamoxifen Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Keywords: tamoxifen
breast cancer
Z-endoxifen
Lead sponsor: Trisakti University
Sponsor class: OTHER
Collaborators: name: Dharmais National Cancer Center Hospital
First posted: 2018-04-20
Enrollment: 117
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient breast cancer patients on tamoxifen treatment for at least 4 months

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Abnormalities in liver markers (AST \>2.5 x ULN)

Primary outcomes:
measure: Genotype and phenotype of CYP2D6
timeFrame: 4 months
Secondary outcomes:
measure: Z-endoxifen
timeFrame: 4 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Dharmais hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Rianto Setiabudy, MD, PhD
role: STUDY_DIRECTOR
References:
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