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NCT04312347 Clinical Trial

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

ER+ Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04312347
Other study ID # TMS01190510
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 6, 2019
Est. completion date June 30, 2021

Study information
Verified date March 2020
Source Nalagenetics Pte Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 151
Est. completion date June 30, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tamoxifen dose adjustment
Patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype will receive tamoxifen dose escalation into 40 mg/day.

Locations
Country Name City State
Indonesia MRCCC Siloam Hospital Semanggi Jakarta DKI Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Nalagenetics Pte Ltd

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

Fox P, Balleine RL, Lee C, Gao B, Balakrishnar B, Menzies AM, Yeap SH, Ali SS, Gebski V, Provan P, Coulter S, Liddle C, Hui R, Kefford R, Lynch J, Wong M, Wilcken N, Gurney H. Dose Escalation of Tamoxifen in Patients with Low Endoxifen Level: Evidence for Therapeutic Drug Monitoring-The TADE Study. Clin Cancer Res. 2016 Jul 1;22(13):3164-71. doi: 10.1158/1078-0432.CCR-15-1470. Epub 2016 Feb 4. — View Citation

Madlensky L, Natarajan L, Tchu S, Pu M, Mortimer J, Flatt SW, Nikoloff DM, Hillman G, Fontecha MR, Lawrence HJ, Parker BA, Wu AH, Pierce JP. Tamoxifen metabolite concentrations, CYP2D6 genotype, and breast cancer outcomes. Clin Pharmacol Ther. 2011 May;89(5):718-25. doi: 10.1038/clpt.2011.32. Epub 2011 Mar 23. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Effects of genotype and phenotype of CYP2D6 on plasma and serum concentration of tamoxifen and its metabolites 8 weeks after initial tamoxifen intake
Primary Effects of dose recommendation of tamoxifen based on CYP2D6 genotyping results on endoxifen levels 8 weeks after dose recommendation
Primary Frequencies of CYP2D6 alleles in female Indonesian population Baseline, pre-intervention
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