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CYP2D6 Genotypes and Breast Cancer Clinical Outcomes in the Indonesian Population

NCT05501158 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-08-19

No results posted yet for this study

Summary

The utilization of tamoxifen is considerably high in Indonesia, with about 170,000 tamoxifen prescriptions filed in 2015. It is metabolized by the enzyme CYP2D6, resulting in its active metabolite, endoxifen, which has been proven to be effective in the prevention and treatment of breast cancer.

Studies showed the CYP2D6 gene has more than 100 variants; some of which are linked with reduced drug activity, while others do not have any pathological implications. The metabolizer profile of these variants is generally grouped into Ultra-rapid, Normal, Intermediate, and Poor Metabolizers (UM, NM, IM, and PM, respectively). In our previous study (NCT04312347), the investigators recruited 150 breast cancer patients who were taking adjusted dose of tamoxifen daily based on their CYP2D6 phenotype. Although the investigators have measured the endoxifen level of the patients with adjusted treatment, the clinical outcomes of the study are not yet conclusive.

Conditions

Interventions

DRUG

Tamoxifen

Suggesting an increase in the dose of tamoxifen to those who have suboptimum level of endoxifen due to their genetic variations

Sponsors & Collaborators

  • SJH Initiatives

    collaborator UNKNOWN

  • Indonesia University

    collaborator OTHER

  • MRCCC Siloam Hospitals Semanggi

    collaborator UNKNOWN

  • Nalagenetics Pte Ltd

    lead INDUSTRY

Principal Investigators

  • Baitha Maggadani, MPharm · Fakultas Farmasi Universitas Indonesia

  • Arief Winata, MD · MRCCC Siloam Hospitals Semanggi

  • Samuel Haryono, MD, PhD · SJH Innitiatives

  • Fatma Aldila, PharmD · Nalagenetics Pte Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2024-04-30
Completion
2024-06-30

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05501158 on ClinicalTrials.gov