The effect of curcumin and piperine on the pharmacokinetics of tamoxifen in patients with estrogen receptor positive breast cancer ‘the ELDORADO study’

Erasmus MC Cancer Institute0 个研究点目标入组 24 人开始时间: 2016年11月23日最近更新: 2018年10月1日

试验速览

暂无简介。

•1. Age = 18 years
•2. Histological or cytological confirmed diagnosis of estrogen receptor positive breast cancer in patients with an indication for tamoxifen treatment.
•3. WHO Performance Status = 1
•4. Able and willing to sign the Informed Consent Form prior to screening evaluations
•5. Abstain from curry, grapefruit (juice), (herbal) dietary supplements besides curcumin, herbals, over-the-counter medication (except for paracetamol and ibuprofen).
•6. Adequate baseline patient characteristics (complete blood count, and serum biochemistry which involves sodium, potassium, creatinin, calculation of creatinin clearance (MDRD), AST, ALT, gamma glutamyltranspeptidase (GGT), lactate dehydrogenase (LDH), ALP, total bilirubin, albumin).
•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 16
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•1. Pregnant or lactating patients.
•2. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria).
•3. Known serious illness or medical unstable conditions that could interfere with this study; requiring treatment (e.g. infection, bleedings, uncontrolled hypertension despite optimal medical management, HIV, hepatitis, organ transplants, kidney, cardiac and respiratory diseases).
•4. Bilirubin CTCAE grade 3 or higher, ASAT/ALAT CTCAE grade 3 or higher. Renal function impairment CTCAE grade 3 or higher.
•5. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 month before the start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than one month before the start of study medication).
•6. Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent.
•7. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
•8. Patients on strong CYP3A4 or CYP2D6 inhibitors or inducers, P-gp substrates or medication or supplements which can interact with tamoxifen and curcumin are not eligible for the study.

发起方

Erasmus MC Cancer Institute