Predicting an accurate tamoxifen dose: a feasibility study in patients with hormone positive breast cancer - PREDICTAM

Erasmus MC Cancer Institute0 个研究点目标入组 100 人开始时间: 2022年8月2日最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•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)

发起方

Erasmus MC Cancer Institute