Study on the pharmacokinetic interaction between diclofenac and tamoxifen in patients with breast cancer. the DICLOTAM study - DICLOTAM study

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 14 人开始时间: 待定最近更新: 2024年4月15日

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.
•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
•- Controlled thyroid dysfunction

•1. Pregnant or lactating patients
•2. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria)
•3. Patients with a history of (stomach) ulcers or gastric bleeding or hypersensitivity to NSAIDs.
•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<60 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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