Predicting an accurate tamoxifen dose: a feasibility study in patients with hormone positive breast cancer
- Conditions
- breast cancermammacarcinoma10006291
- Registration Number
- NL-OMON53836
- Lead Sponsor
- niversitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 115
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Age >= 18 years;
2. WHO Performance Status <= 1
3. Patients with primary breast cancer, with a prescription for adjuvant
tamoxifen treatment.
4. Willing to abstain from strong and moderate CYP3A4 or CYP2D6 inhibitors or
inducers, according to: CYTOCHROME P450 DRUG INTERACTION TABLE - Drug
Interactions (iu.edu);
5. Able and willing to sign the Informed Consent Form;
6. Able and willing to undergo blood sampling for PK analysis.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Patients with known alcoholism, drug addiction and/or psychiatric or
physiological condition which in the opinion of the investigator would impair
treatment compliance;
2. > 2 weeks of tamoxifen treatment before inclusion
3. Patients who*s endoxifen levels have been used for therapeutic drug
monitoring in the past.
4. Evidence of a neurological disorder which might affect cognitive functioning
(only for cognition scan part)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method