Therapeutic Drug Monitoring guided tamoxifen dosing: a feasibility study in patients with hormone positive breast cancer

Erasmus MC Cancer Institute0 个研究点目标入组 400 人开始时间: 2018年1月16日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•1. Adult women (= 18 years of age) who are planned to start adjuvant tamoxifen therapy.
•2. WHO Performance Status = 1
•3. Able and willing to sign the Informed Consent Form prior to screening evaluations
•4. 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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•1. Woman who are pregnant or breast feeding;
•2. Endometrial cancer (diagnosis < 3 years ago)
•3. Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent.
•4. Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair treatment compliance.
•5. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of tamoxifen or puts the patient at high risk for treatment related complications.
•6. =3 months tamoxifen treatment without TDM or start dose >20 mg OD.

发起方

Erasmus MC Cancer Institute