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

Interne Oncologie0 个研究点目标入组 457 人开始时间: 待定最近更新: 2024年4月15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
•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.

•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

Interne Oncologie