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

NCT04312347 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2021-08-05

No results posted yet for this study

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.

Conditions

  • ER+ Breast Cancer

Interventions

DRUG

Tamoxifen dose adjustment

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

Sponsors & Collaborators

  • Nalagenetics Pte Ltd

    lead INDUSTRY

Principal Investigators

  • Baitha P. Maggadani · Department of Pharmacy, University of Indonesia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-06
Primary Completion
2021-05-01
Completion
2021-06-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04312347 on ClinicalTrials.gov