Tamoxifen Dose Adjustment on Indonesian Female ER+ Breast Cancer Patients Based on CYP2D6 Genotype and Endoxifen Levels

Not Applicable

Completed

• Conditions: ER+ Breast Cancer
• Interventions: Drug: Tamoxifen dose adjustment

• Registration Number: NCT04312347
• Lead Sponsor: Nalagenetics Pte Ltd

Brief Summary

The objectives of this study is to perform CYP2D6 genotyping and metabolite concentrations analysis on ER+ breast cancer patients who are taking tamoxifen and give dose recommendations based on the CYP2D6 genotypes and endoxifen levels.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-06
• Status Verified: 2020-03
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-18
• Primary Completion: 2021-05-01
• Study Completion: 2021-06-30
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 151

Inclusion Criteria

• Diagnosed with ER+ breast cancer
• Have taken tamoxifen daily for at least 2 months

Exclusion Criteria

• Have not taken tamoxifen daily for at least 2 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personalized dosing of tamoxifen	Tamoxifen dose adjustment	Increase tamoxifen dose into 40 mg/day for patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype.

Primary Outcome Measures

Name	Time	Method
Effects of dose recommendation of tamoxifen based on CYP2D6 genotyping results on endoxifen levels	8 weeks after dose recommendation
Frequencies of CYP2D6 alleles in female Indonesian population	Baseline, pre-intervention
Effects of genotype and phenotype of CYP2D6 on plasma and serum concentration of tamoxifen and its metabolites	8 weeks after initial tamoxifen intake

Trial Locations

Locations (1)

MRCCC Siloam Hospital Semanggi; 🇮🇩 Jakarta, DKI Jakarta, Indonesia