Study on the pharmacokinetic interaction between green tea and tamoxifen in patients with breast cancer. the TEA study”

Erasmus MC0 个研究点目标入组 14 人开始时间: 2019年10月7日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•1.Age = 18 years
•2.Patients with a confirmed diagnosis of primary or advanced breast cancer, who are on tamoxifen treatment for at least three months (steady state concentration).
•3.WHO performance = 1 (see Appendix B)
•4.Able and willing to sign the informed consent form prior to screening evaluations
•5.Willing to abstain from strong CYP3A4, CYP2D6, CYP2C9/2C19, UGT and P-gp inhibitors or inducers, herbal or dietary supplements or other over-the-counter medication besides paracetamol. (see Appendix C)
•6.Adequate organ function defined as:
•-ALAT and ASAT <5.0 upper limit of normal (ULN)
•-bilirubin <1.5 (ULN)
•-GFR > 30 ml/min/1.73 m2
•7.Endoxifen trough concentration of 16 nM
•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 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•1.Pregnant or lactating patients
•2.Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria)
•3.Patients with an active gastric ulcer
•4.Known serious illness or medical unstable conditions that could interfere with this study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or herpes zoster, organ transplants, kidney failure (GFR<30 ml/min/1.73 m2), serious liver disease (e.g. severe cirrhosis), cardiac and respiratory diseases)
•5.A CYP2D6 poor metabolizer or ultra-rapid metabolizer phenotype based on CYP2D6 genotyping outcome.

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