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

August 4, 2021 updated by: Nalagenetics Pte Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 12930
        • MRCCC Siloam Hospital Semanggi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Personalized dosing of tamoxifen
Increase tamoxifen dose into 40 mg/day for patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype.
Drug: Tamoxifen dose adjustment
Patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype will receive tamoxifen dose escalation into 40 mg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks after initial tamoxifen intake
Effects of dose recommendation of tamoxifen based on CYP2D6 genotyping results on endoxifen levels
Time Frame: 8 weeks after dose recommendation
8 weeks after dose recommendation
Frequencies of CYP2D6 alleles in female Indonesian population
Time Frame: Baseline, pre-intervention
Baseline, pre-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nalagenetics Pte Ltd

Investigators

  • Principal Investigator: Baitha P. Maggadani, Department of Pharmacy, University of Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 6, 2019

Primary Completion (ACTUAL)

May 1, 2021

Study Completion (ACTUAL)

June 30, 2021

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (ACTUAL)

March 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMS01190510

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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