CYP2D6 Genotypes and Breast Cancer Clinical Outcomes in the Indonesian Population

August 17, 2022 updated by: Nalagenetics Pte Ltd

CYP2D6 Genotypes and Breast Cancer Clinical Outcomes in the Indonesian Population (Pengaruh Genotipe CYP2D6 Terhadap Efektivitas Penggunaan Tamoksifen Untuk Pasien Kanker Payudara ER+ Pada Populasi Indonesia)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

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 Hospitals 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. female
  2. diagnosed with ER+ breast cancer
  3. have been genotyped and classified as PM and IM in the previous study
  4. are recommended by doctor to take tamoxifen 40 mg according to their metabolizer profile
  5. have finished the definitive therapy course (surgery, chemotherapy, or radiotherapy).

Exclusion Criteria:

  1. have other primary cancer aside from breast cancer.
  2. those with residual tumor cells/have experienced second primary breast tumor.
  3. patients who are recommended by doctor to switch to aromatase inhibitors (AI)

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dose adjustment of tamoxifen
Following the CPIC guidelines, those identified as Poor Metabolizers (PMs) and Intermediate Metabolizers (IMs) from our previous study are recommended to adjust their tamoxifen dosage to 40 mg per day.
Drug: Tamoxifen
Suggesting an increase in the dose of tamoxifen to those who have suboptimum level of endoxifen due to their genetic variations
NO_INTERVENTION: Standard dose of tamoxifen
Those identified as Normal Metabolizers (NMs) from our previous study remain on tamoxifen 20 mg per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival rate
Time Frame: 3 year
The percentage of study participants who are still alive by the end of this study after being diagnosed with breast cancer
3 year
Progression Survival rate
Time Frame: 3 year
The percentage of study participants who live with the disease but the disease does not get worse by the end of this study
3 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term side effects of tamoxifen
Time Frame: 3 year
Long-term side effects of tamoxifen, including heartburn, thromboembolic event, endometrial hyperplasia and uterine cancer, will also be monitored and documented using the Adverse Drug Reaction (ADR) reporting form provided by the Indonesian National Agency of Drug and Food Control.
3 year

Collaborators and Investigators

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

Sponsor

Nalagenetics Pte Ltd

Collaborators

Indonesia University
SJH Initiatives
MRCCC Siloam Hospitals Semanggi

Investigators

  • Study Chair: Baitha Maggadani, MPharm, Fakultas Farmasi Universitas Indonesia
  • Study Chair: Arief Winata, MD, MRCCC Siloam Hospitals Semanggi
  • Principal Investigator: Samuel Haryono, MD, PhD, SJH Innitiatives
  • Study Chair: Fatma Aldila, PharmD, Nalagenetics Pte Ltd

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)

January 1, 2021

Primary Completion (ANTICIPATED)

April 30, 2024

Study Completion (ANTICIPATED)

June 30, 2024

Study Registration Dates

First Submitted

August 12, 2022

First Submitted That Met QC Criteria

August 12, 2022

First Posted (ACTUAL)

August 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID-TMS-02-20201012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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