The effect of curcumin and piperine on the pharmacokinetics of tamoxifen in patients with breast cancer *the ELDORADO study*

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 17

Inclusion Criteria

1. Age * 18 years;2. Histological or cytological confirmed diagnosis of 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).

Exclusion Criteria

1. Pregnant or lactating patients.;2. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria).;3. Use of other drugs, which are mainly dependent for their metabolism on CYP3A4 and CYP2D6. ;4. 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).;5. Bilirubin CTCAE grade 2 or higher, ASAT/ALAT CTCAE grade 2 or higher and grade 3 or higher in patients with liver metastasis. . Renal function impairment CTCAE grade 2 or higher.;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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the influence of curcumin with or without piperine, in patients<br /><br>with breast cancer, on endoxifen plasma pharmacokinetics. The main parameter<br /><br>will be AUC. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Other pharmacokinetic outcomes (i.e. clearance, minimum concentration<br /><br>(Ctrough) and the tamoxifen/endoxifen ratio.<br /><br>2. To evaluate plasma concentration levels of tamoxifen and other tamoxifen<br /><br>metabolites<br /><br>3. To evaluate the incidence and severity of side-effects of treatment with<br /><br>tamoxifen in absence and presence of curcumin with or without piperine.</p><br>