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Status unknownNCT03504631Updated Apr 24, 2018

Genotyping and Phenotyping of CYP2D6 Breast Cancer Patients on Tamoxifen

An observational study in Breast Cancer Female, sponsored by Trisakti University. Status unknown at 1 site in Indonesia. Open to female participants. Per ClinicalTrials.gov, last updated 2018-04-24.

Sponsored by Trisakti University · Observational

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
117
Sex
Female
01

Study summary

This study is an observational study to determine phenotype and genotype of CYP2D6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months

Read the detailed description

Tamoxifen is an antiestrogen drug with concentration dependent properties, with z-endoxifen known as active metabolite. Until know therapeutic range for z-endoxifen to improve treatment response was not known. Variation response on tamoxifen can be cause of genetic polymorphism CYP2D6 that can be different between interindividul and ethnic.

The aim of this study is to determine phenotype and genotype of CYP2D6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months

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Conditions studied

  • Breast Cancer Female

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Keywords

  • tamoxifen
  • breast cancer
  • Z-endoxifen
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In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 117 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Trisakti University is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Outpatient breast cancer patients on tamoxifen treatment for at least 4 months

Inclusion criteria

  • Breast cancer patients on tamoxifen treatment for at least 4 months

Exclusion criteria

Exclusion Criteria:

  • Abnormalities in liver markers (AST >2.5 x ULN)
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
117 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Breast cancer patients on tamoxifen

    Patients currently on treatment with tamoxifen for at least 4 months.

    Other: No intervention

Interventions

  • OtherNo intervention

    no intervention

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What researchers measure

Primary outcomes

  1. Genotype and phenotype of CYP2D6

    Number of subjects with CYP2D6 genotype and phenotype who had steady state level

    Time frame: 4 months

Secondary outcomes

  1. Z-endoxifen

    Number of subjects with plasma levels of Z-endoxifen more than 5.9 ng/mL

    Time frame: 4 months

07

Study locations

1 of 1 sites recruiting
  • Dharmais hospital
    Jakarta, DKI Jakarta 11420, Indonesia
    Recruiting
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References and documents

Publications

  • 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. PubMed 21430657 ↗
  • Jager NG, Rosing H, Schellens JH, Linn SC, Beijnen JH. Tamoxifen dose and serum concentrations of tamoxifen and six of its metabolites in routine clinical outpatient care. Breast Cancer Res Treat. 2014 Feb;143(3):477-83. doi: 10.1007/s10549-013-2826-1. Epub 2014 Jan 5. PubMed 24390246 ↗
  • Tamminga WJ, Wemer J, Oosterhuis B, Brakenhoff JP, Gerrits MG, de Zeeuw RA, de Leij LF, Jonkman JH. An optimized methodology for combined phenotyping and genotyping on CYP2D6 and CYP2C19. Eur J Clin Pharmacol. 2001 May;57(2):143-6. doi: 10.1007/s002280100273. PubMed 11417446 ↗
  • Desta Z, Ward BA, Soukhova NV, Flockhart DA. Comprehensive evaluation of tamoxifen sequential biotransformation by the human cytochrome P450 system in vitro: prominent roles for CYP3A and CYP2D6. J Pharmacol Exp Ther. 2004 Sep;310(3):1062-75. doi: 10.1124/jpet.104.065607. Epub 2004 May 24. PubMed 15159443 ↗
  • Fotoohi AK, Karim H, Lafolie P, Pohanka A, Ostervall J, Hatschek T, Vitols S. Pronounced Interindividual But Not Intraindividual Variation in Tamoxifen and Metabolite Levels in Plasma During Adjuvant Treatment of Women With Early Breast Cancer. Ther Drug Monit. 2016 Apr;38(2):239-45. doi: 10.1097/FTD.0000000000000257. PubMed 26485084 ↗
  • Hennig EE, Piatkowska M, Karczmarski J, Goryca K, Brewczynska E, Jazwiec R, Kluska A, Omiotek R, Paziewska A, Dadlez M, Ostrowski J. Limited predictive value of achieving beneficial plasma (Z)-endoxifen threshold level by CYP2D6 genotyping in tamoxifen-treated Polish women with breast cancer. BMC Cancer. 2015 Aug 1;15:570. doi: 10.1186/s12885-015-1575-4. PubMed 26232141 ↗
  • Antunes MV, Linden R, Santos TV, Wallemacq P, Haufroid V, Classen JF, Andreolla H, Costa N, Fontanive TO, Rosa DD. Endoxifen levels and its association with CYP2D6 genotype and phenotype: evaluation of a southern Brazilian population under tamoxifen pharmacotherapy. Ther Drug Monit. 2012 Aug;34(4):422-31. doi: 10.1097/FTD.0b013e318260b46e. PubMed 22777153 ↗
  • Lei L, Wang X, Wu XD, Wang Z, Chen ZH, Zheng YB, Wang XJ. Association of CYP2D6*10 (c.100C>T) polymorphisms with clinical outcome of breast cancer after tamoxifen adjuvant endocrine therapy in Chinese population. Am J Transl Res. 2016 Aug 15;8(8):3585-92. eCollection 2016. PubMed 27648149 ↗
  • Hawse JR, Subramaniam M, Cicek M, Wu X, Gingery A, Grygo SB, Sun Z, Pitel KS, Lingle WL, Goetz MP, Ingle JN, Spelsberg TC. Endoxifen's molecular mechanisms of action are concentration dependent and different than that of other anti-estrogens. PLoS One. 2013;8(1):e54613. doi: 10.1371/journal.pone.0054613. Epub 2013 Jan 28. PubMed 23382923 ↗
  • Bagheri A, Kamalidehghan B, Haghshenas M, Azadfar P, Akbari L, Sangtarash MH, Vejdandoust F, Ahmadipour F, Meng GY, Houshmand M. Prevalence of the CYP2D6*10 (C100T), *4 (G1846A), and *14 (G1758A) alleles among Iranians of different ethnicities. Drug Des Devel Ther. 2015 May 13;9:2627-34. doi: 10.2147/DDDT.S79709. eCollection 2015. PubMed 25999696 ↗
  • Zhou SF. Polymorphism of human cytochrome P450 2D6 and its clinical significance: Part I. Clin Pharmacokinet. 2009;48(11):689-723. doi: 10.2165/11318030-000000000-00000. PubMed 19817501 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03504631
Lead sponsor
Trisakti University
Collaborators
Dharmais National Cancer Center Hospital
Responsible party
Yenny Farmako (Head of Pharmacology, Trisakti University) — Principal investigator
First posted
Apr 20, 2018
Start date
Oct 1, 2017
Primary completion
Oct 1, 2018 (estimated)
Completion
Dec 1, 2018 (estimated)
Last update
Apr 24, 2018

Study contacts

Yenny, MD
Contact
yenfarmako@gmail.com
+628159661333
Rianto Setiabudy, MD, PhD
study director · Indonesia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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