Optimizing endoxifen concentration through the induction of CYP3A4, CYP2C and CYP2D6 mediated tamoxifen metabolism - Induction of tamoxifen metabolism

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Histological or cytological confirmed diagnosis of (invasive) breast cancer, for which treatment with tamoxifen monotherapy is indicated (to be evaluated by the treating physician);
•Use of tamoxifen monotherapy for at least 4 weeks (to guarantee steady-state) and willing to continue the treatment until the end of the study;
•Age >18 years;
•WHO performance <1;
•Adequate renal and hepatic functions (serum creatinin < 1.25x upper limit of normal (ULN), total bilirubin < 1.25xULN; alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) < 2.5x ULN, in case of liver metastasis < 5 ULN; alkaline phosphatase (AF) < 5xULN);
•Adequate hematological blood counts (absolute neutrophil count (ANC) > 1.5 x 109/L, platelets > 100 x 1012/L);
•Written informed consent;
•No chemotherapy within the last 4 weeks before start;
•No radiotherapy within the last 4 weeks before start;
•No concurrent (over the counter) medication or (herbal) supplements known to induce or inhibit CYP2D6, CYP2C, CYP3A4 and/or P-glycoprotein;
•Abstain from grapefruit, grapefruit juice, herbal dietary supplements, and herbal tea during the study.

•Pregnant or lactating patients;
•Impossibility to take oral drugs;
•Serious illness or medical unstable condition requiring treatment, symptomatic CNS-metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;
•Contra-indications for dextromethorphan use;
•Use of medications or dietary supplements known to induce or inhibit CYP2D6, CYP2C, CYP3A4 and/or P-glycoprotein;
•Unwillingness to abstain from grapefruit (juice), (herbal) dietary supplements, herbals, over-the-counter medication (except for paracetamol and ibuprofen) and other drugs known to seriously interact with CYP3A during the study period;
•Non-compliance

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