Skip to main content
OpenTrials
Completed

NCT Number: NCT04312347

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ER+ Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MRCCC Siloam Hospital Semanggi

Jakarta, DKI Jakarta, 12930, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamoxifen dose adjustment

Drug

Patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype will receive tamoxifen dose escalation into 40 mg/day.

Primary outcomes

  1. Effects of genotype and phenotype of CYP2D6 on plasma and serum concentration of tamoxifen and its metabolites

    Time frame: 8 weeks after initial tamoxifen intake

  2. Effects of dose recommendation of tamoxifen based on CYP2D6 genotyping results on endoxifen levels

    Time frame: 8 weeks after dose recommendation

  3. Frequencies of CYP2D6 alleles in female Indonesian population

    Time frame: Baseline, pre-intervention

Sponsors and collaborators

Lead sponsor

Nalagenetics Pte Ltd

Industry

Registry information

Official study title

Tamoxifen Dose Adjustment on ER+ Breast Cancer Patients Based on Genomic and Metabolite Concentrations Analysis

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2020
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.