Tamoxifen Dose Adjustment on Indonesian Female ER+ Breast Cancer Patients Based on CYP2D6 Genotype and Endoxifen Levels
NCT ID: NCT04312347
Last Updated: 2021-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
151 participants
INTERVENTIONAL
2019-09-06
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Personalized dosing of tamoxifen
Increase tamoxifen dose into 40 mg/day for patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype.
Tamoxifen dose adjustment
Patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype will receive tamoxifen dose escalation into 40 mg/day.
Interventions
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Tamoxifen dose adjustment
Patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype will receive tamoxifen dose escalation into 40 mg/day.
Eligibility Criteria
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Inclusion Criteria
* Have taken tamoxifen daily for at least 2 months
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Nalagenetics Pte Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Baitha P. Maggadani
Role: PRINCIPAL_INVESTIGATOR
Department of Pharmacy, University of Indonesia
Locations
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MRCCC Siloam Hospital Semanggi
Jakarta, DKI Jakarta, Indonesia
Countries
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References
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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.
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.
Other Identifiers
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TMS01190510
Identifier Type: -
Identifier Source: org_study_id
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