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

NCT00717015 | Completed

• 1 other identifier: BR02/06/06
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Hormone Receptor Positive Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We aim to enroll 200 patients onto our study over a period of 2 years. Patients will be recruited from the oncology outpatient clinic in National University Hospital. Participation in the study will be strictly voluntary and written informed consent will be obtained from all subjects according to institutional and governmental guidelines. Consent will be obtained by attending doctors or co-investigators of the study prior to blood sampling.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chiung Ing Wong, MRCP, MB ChB

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: November 1, 2005
• Last Updated: April 3, 2012

Record last verified: 2012-04

Locations

SG (1)