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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717015
• Other study ID #: BR02/06/06
• Status: Completed
• Phase: N/A
• First received: July 14, 2008
• Last updated: April 2, 2012
• Start date: November 2005

Study information

• Verified date: April 2012
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the steady state pharmacokinetics of tamoxifen and its metabolites			No
Primary	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.			No