The effects of switching antidepressants on endoxifen exposure - Switch study

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 13 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•- Histological or cytological confirmed diagnosis of breast cancer, for which treatment with tamoxifen is indicated (to be evaluated by the treating physician);
•- Use of tamoxifen for at least 4 weeks (to guarantee steady-state) and willing to continue the treatment until the end of the study;
•- Concomitant use of paroxetine for at least 4 weeks (Amendment: or other antidepressant which has been shown to inhibit CYP2D6 in vitro/in vivo);
•- Age > 18 years;
•- WHO performance < 1;
•- Adequate renal and hepatic functions (see protocol);
•- Adequate hematological blood counts (see protocol);
•- 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, except SSRIs (Amendment: current antidepressant), known to induce or inhibit CYP2D6, CYP2C, CYP3A4 and/or P-glycoprotein;
•- No concurrent medication or supplements which can interact with venlafaxine and/or escitalopram;
•- Abstain from grapefruit, grapefruit juice, herbal dietary supplements, and herbal tea during the study.

•- Pregnant or lactating patients;
•- 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;
•- Patients with a history of suicide attempts or current suicidal ideation;
•- Contra-indications for venlafaxine and/or escitalopram use;
•- Patients with Congenital Long QT Syndrome (CLQTS);
•- 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);
•- More than one dose of tamoxifen (20 or 40 mg) per day;
•- Non-compliance.

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