Tamoxifen Pharmacokinetics and CYP2D6 Polymorphisms in Asian Women With Hormone Receptor Positive Breast Cancer
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT00717015
- Lead Sponsor
- National University Hospital, Singapore
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. To determine the steady state pharmacokinetics of tamoxifen and its metabolites
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National University Hospital
🇸🇬Singapore, Singapore