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Genotyping and Phenotyping of CYP2D6 Breast Cancer Patients on Tamoxifen

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ClinicalTrials.gov Identifier: NCT03504631
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
Dharmais National Cancer Center Hospital
Information provided by (Responsible Party):
Yenny Farmako, Trisakti University

Brief Summary:
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

Condition or disease Intervention/treatment
Breast Cancer Female Other: No intervention

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


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Study Type : Observational
Estimated Enrollment : 117 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Genotyping and Phenotyping of CYP2D6 as Predictor of Z-endoxifen Plasma Levels in Breast Cancer Patients on Tamoxifen Treatment
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. Genotype and phenotype of CYP2D6 [ Time Frame: 4 months ]
    Number of subjects with CYP2D6 genotype and phenotype who had steady state level


Secondary Outcome Measures :
  1. Z-endoxifen [ Time Frame: 4 months ]
    Number of subjects with plasma levels of Z-endoxifen more than 5.9 ng/mL


Biospecimen Retention:   Samples With DNA
Blood samples from breast cancer patients treated with Z-endoxifen were drawn for analysis of genotype and phenotype of CYP2D6, as well as the plasma concentration of Z-endoxifen


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female only
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatient breast cancer patients on tamoxifen treatment for at least 4 months
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504631


Contacts
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Contact: Yenny, MD +628159661333 yenfarmako@gmail.com

Locations
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Indonesia
Dharmais hospital Recruiting
Jakarta, DKI Jakarta, Indonesia, 11420
Contact: Denni Jokopurwanto, MD, PhD    +62811153590    dennijoko@gmail.com   
Sponsors and Collaborators
Trisakti University
Dharmais National Cancer Center Hospital
Investigators
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Study Director: Rianto Setiabudy, MD, PhD Indonesia University

Publications:

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Responsible Party: Yenny Farmako, Head of Pharmacology, Trisakti University
ClinicalTrials.gov Identifier: NCT03504631     History of Changes
Other Study ID Numbers: 1001
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yenny Farmako, Trisakti University:
tamoxifen
breast cancer
Z-endoxifen

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents