Tamoxifen Dose Adjustment on Indonesian Female ER+ Breast Cancer Patients Based on CYP2D6 Genotype and Endoxifen Levels
Sponsor
Nalagenetics Pte Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT04312347
Collaborator
(none)
151
1
1
21.8
6.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
151 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Tamoxifen Dose Adjustment on ER+ Breast Cancer Patients Based on Genomic and Metabolite Concentrations Analysis
Actual Study Start Date
:
Sep 6, 2019
Actual Primary Completion Date
:
May 1, 2021
Actual Study Completion Date
:
Jun 30, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Personalized dosing of tamoxifen Increase tamoxifen dose into 40 mg/day for patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype. |
Drug: Tamoxifen dose adjustment
Patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype will receive tamoxifen dose escalation into 40 mg/day.
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MRCCC Siloam Hospital Semanggi | Jakarta | DKI Jakarta | Indonesia | 12930 |
Sponsors and Collaborators
- Nalagenetics Pte Ltd
Investigators
- Principal Investigator: Baitha P. Maggadani, Department of Pharmacy, University of Indonesia
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
Responsible Party:
Nalagenetics Pte Ltd
ClinicalTrials.gov Identifier:
NCT04312347
Other Study ID Numbers:
- TMS01190510
First Posted:
Mar 18, 2020
Last Update Posted:
Aug 5, 2021
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nalagenetics Pte Ltd
Additional relevant MeSH terms: