CYPTAM study.
Completed
- Conditions
- women with early stage breast cancerusing adjuvant tamoxifenDutch:patientes met vroeg-stadium mammacarcinoom behandeld met adjuvant tamoxifen
- Registration Number
- NL-OMON23389
- Lead Sponsor
- eiden University Medical Center (LUMC)Leiden, the Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 650
Inclusion Criteria
1. Pre- and postmenopausal women who will receive tamoxifen or have already been using tamoxifen during a maximum period of one year, as part of a standard adjuvant therapy for newly diagnosed breast cancer.
Exclusion Criteria
1. Other malignancy within the previous 5 years (except adequately treated in situ carcinoma of cervix or basal cell carcinoma).
2. Hormone receptor negative primary tumors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To associate CYP2D6 genotype and tamoxifen metabolite plasma concentration to relapse free survival (RFS), disease free survival (DFS) and overall survival (OS) (documentation study).<br /><br>2. To investigate the effect of a temporary one-step dose escalation of tamoxifen on endoxifen plasma concentration in poor and intermediate metabolizers (pharmacokinetics study).<br><br /><br /><br>Amendment: To correlate the CYP2D6 genotype and the serum endoxifen concentrations to the CYP2D6 phenotype determined by a dextromethorphan breath test (DM-BT).
- Secondary Outcome Measures
Name Time Method