Estrogen receptor positive breast cancer
Conditions
Interventions
Trade Name: Tamoxifen
Pharmaceutical Form: Coated tablet
Sponsors
Erasmus MC Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the influence of curcumin with or without piperine, in patients with estrogen receptor positive breast cancer, on tamoxifen/endoxifen plasma pharmacokinetics (AUC).;Secondary Objective: 1. Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax) and time to Cmax (tmax)) and the tamoxifen/endoxifen ratio. 2. To evaluate the incidence and severity of side-effects of treatment with tamoxifen in absence and presence of curcumin with or without piperine. ;Primary end point(s): To determine the influence of curcumin with or without piperine, in patients with estrogen receptor positive breast cancer, on tamoxifen/endoxifen plasma pharmacokinetics (AUC).;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax) and time to Cmax (tmax)) and the tamoxifen/endoxifen ratio. 2. To evaluate the incidence and severity of side-effects of treatment with tamoxifen in absence and presence of curcumin with or without piperine. ;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Netherlands
Contacts
Public ContactRon Mathijssen
Erasmus MC
Outcome results
None listed