Tamoxifen Dose Adjustment on Indonesian Female ER+ Breast Cancer Patients Based on CYP2D6 Genotype and Endoxifen Levels
Tamoxifen Dose Adjustment on ER+ Breast Cancer Patients Based on Genomic and Metabolite Concentrations Analysis
1 other identifier
interventional
151
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 6, 2019
CompletedFirst Submitted
Initial submission to the registry
March 5, 2020
CompletedFirst Posted
Study publicly available on registry
March 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedAugust 5, 2021
March 1, 2020
1.7 years
March 5, 2020
August 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Effects of genotype and phenotype of CYP2D6 on plasma and serum concentration of tamoxifen and its metabolites
8 weeks after initial tamoxifen intake
Effects of dose recommendation of tamoxifen based on CYP2D6 genotyping results on endoxifen levels
8 weeks after dose recommendation
Frequencies of CYP2D6 alleles in female Indonesian population
Baseline, pre-intervention
Study Arms (1)
Personalized dosing of tamoxifen
EXPERIMENTALIncrease tamoxifen dose into 40 mg/day for patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype.
Interventions
Patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype will receive tamoxifen dose escalation into 40 mg/day.
Eligibility Criteria
You may qualify if:
- Diagnosed with ER+ breast cancer
- Have taken tamoxifen daily for at least 2 months
You may not qualify if:
- Have not taken tamoxifen daily for at least 2 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MRCCC Siloam Hospital Semanggi
Jakarta, DKI Jakarta, 12930, Indonesia
Related Publications (2)
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.
PMID: 21430657BACKGROUNDFox 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.
PMID: 26847054BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baitha P. Maggadani
Department of Pharmacy, University of Indonesia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2020
First Posted
March 18, 2020
Study Start
September 6, 2019
Primary Completion
May 1, 2021
Study Completion
June 30, 2021
Last Updated
August 5, 2021
Record last verified: 2020-03