Tamoxifen Pharmacokinetics and CYP2D6 Polymorphisms in Asian Women With Hormone Receptor Positive Breast Cancer

NCT ID: NCT00717015

Last Updated: 2012-04-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-30

Brief Summary

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We hypothesized that subjects with CYP2D6\*10 alleles may have a lower steady state levels of endoxifen due to reduced conversion of tamoxifen to endoxifen.

Primary objectives:

* To determine the steady state pharmacokinetics of tamoxifen and its metabolites
* To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of tamoxifen and its metabolites in hormone receptor positive women who are taking tamoxifen as adjuvant treatment for breast cancer.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent.
* At least 18 years of age.
* On tamoxifen for at least 3 months for adjuvant therapy.
* On a stable diet for past 1 week before blood sampling.
* Compliant with tamoxifen medication.
* Completed adjuvant chemotherapy and/or adjuvant radiation therapy.

Exclusion Criteria

• Patients should not be on the list of medications for the last 1 week before accrual to the study
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Principal Investigators

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Chiung Ing Wong, MRCP, MB ChB

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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National University Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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BR02/06/06

Identifier Type: -

Identifier Source: org_study_id

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