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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04312347
Recruitment Status : Completed
First Posted : March 18, 2020
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Nalagenetics Pte Ltd

Study Description
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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
ER+ Breast Cancer Drug: Tamoxifen dose adjustment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : September 6, 2019
Actual Primary Completion Date : May 1, 2021
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Effects of genotype and phenotype of CYP2D6 on plasma and serum concentration of tamoxifen and its metabolites [ Time Frame: 8 weeks after initial tamoxifen intake ]
  2. Effects of dose recommendation of tamoxifen based on CYP2D6 genotyping results on endoxifen levels [ Time Frame: 8 weeks after dose recommendation ]
  3. Frequencies of CYP2D6 alleles in female Indonesian population [ Time Frame: Baseline, pre-intervention ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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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): NCT04312347


Locations
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Indonesia
MRCCC Siloam Hospital Semanggi
Jakarta, DKI Jakarta, Indonesia, 12930
Sponsors and Collaborators
Nalagenetics Pte Ltd
Investigators
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Principal Investigator: Baitha P. Maggadani Department of Pharmacy, University of Indonesia
More Information
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Publications:

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Responsible Party: Nalagenetics Pte Ltd
ClinicalTrials.gov Identifier: NCT04312347    
Other Study ID Numbers: TMS01190510
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: March 2020

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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 Nalagenetics Pte Ltd:
breast cancer
tamoxifen
CYP2D6
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