Study on the possible pharmacokinetic interaction between green tea supplements and tamoxifen in patients with breast cancer.

Erasmus MC0 个研究点目标入组 14 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•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. Willing to abstain from a cup of green tea (<4 h after tamoxifen intake)

•1. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria)
•2. Patients with an active gastric ulcer
•3. Patients with a BMI >35 kg/m2
•4. Age >80 years
•5. 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)
•6. A CYP2D6 poor metabolizer or ultra-rapid metabolizer phenotype based on CYP2D6 genotyping outcome
•7. Use of strong CYP3A4, CYP2D6, CYP2C9/2C19, UGT and P-gp inhibitors or inducers , herbal or dietary supplements or other over-the-counter medication besides paracetamol (e.g. Veregen, grapefruit, st. Johns-wort)

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