Genotyping and Phenotyping of CYP2D6 Breast Cancer Patients on Tamoxifen

April 23, 2018 updated by: Yenny Farmako, Trisakti University

Genotyping and Phenotyping of CYP2D6 as Predictor of Z-endoxifen Plasma Levels in Breast Cancer Patients on Tamoxifen Treatment

This study is an observational study to determine phenotype and genotype of CYP2D6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Tamoxifen is an antiestrogen drug with concentration dependent properties, with z-endoxifen known as active metabolite. Until know therapeutic range for z-endoxifen to improve treatment response was not known. Variation response on tamoxifen can be cause of genetic polymorphism CYP2D6 that can be different between interindividul and ethnic.

The aim of this study is to determine phenotype and genotype of CYP2D6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months

Study Type

Observational

Enrollment (Anticipated)

117

Contacts and Locations

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

Study Contact

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 11420
        • Recruiting
        • Dharmais hospital
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Outpatient breast cancer patients on tamoxifen treatment for at least 4 months

Description

Inclusion Criteria:

  • Breast cancer patients on tamoxifen treatment for at least 4 months

Exclusion Criteria:

  • Abnormalities in liver markers (AST >2.5 x ULN)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast cancer patients on tamoxifen
Patients currently on treatment with tamoxifen for at least 4 months.
Other: No intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genotype and phenotype of CYP2D6
Time Frame: 4 months
Number of subjects with CYP2D6 genotype and phenotype who had steady state level
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Z-endoxifen
Time Frame: 4 months
Number of subjects with plasma levels of Z-endoxifen more than 5.9 ng/mL
4 months

Collaborators and Investigators

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

Sponsor

Trisakti University

Collaborators

Dharmais National Cancer Center Hospital

Investigators

  • Study Director: Rianto Setiabudy, MD, PhD, Indonesia University

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)

October 1, 2017

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

April 24, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1001 (Registro Nacional Estudios Clinicos (RNEC))

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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