Tamoxifen prediction study in patients with hormone positive breast cancer: the PREDICTAM study
- Conditions
- Hormone positive breast cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2022-002426-28-NL
- Lead Sponsor
- Erasmus MC Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 100
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method