Breast cancer
Conditions
Interventions
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Patients with a confirmed diagnosis of primary or advanced breast cancer, who are on tamoxifen treatment for at least three months (steady state concentration). 3. WHO performance = 1 (see Appendix B) 4. Able and willing to sign the informed consent form prior to screening evaluations 5. Willing to abstain from strong CYP3A4, CYP2D6, CYP2C9/2C19, UGT and P-gp inhibitors or inducers, herbal or dietary supplements or other over-the-counter medication besides paracetamol. (see Appendix C) 6. Adequate organ function defined as: - ALAT and ASAT 30 ml/min/1.73 m2 7. Endoxifen trough concentration of 16 nM 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients 2. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria) 3. Patients with an active gastric ulcer 4. Known serious illness or medical unstable conditions that could interfere with this study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or herpes zoster, organ transplants, kidney failure (GFR<30 ml/min/1.73 m2), serious liver disease (e.g. severe cirrhosis), cardiac and respiratory diseases) 5. A CYP2D6 poor metabolizer or ultra-rapid metabolizer phenotype based on CYP2D6 genotyping outcome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the Area under the curve (AUC) of endoxifen in patients with breast cancer treated with tamoxifen with and without green tea.;Secondary Objective: 1. To compare the Area under the Curve (AUC) of tamoxifen in patients with breast cancer treated with tamoxifen with and without green tea. 2. To compare other tamoxifen and endoxifen pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax), minimal concentration (Ctrough) and time until maximum concentration (tmax) and elimination half-life (t½)). in patients with breast cancer treated with tamoxifen with and without green tea. 3. To evaluate the incidence and severity of side-effects of treatment with tamoxifen in absence and presence of green tea. ;Primary end point(s): To compare the Area under the curve (AUC) of endoxifen in patients with breast cancer treated with tamoxifen with and without green tea.;Timepoint(s) of evaluation of this end point: Last visit last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To compare the Area under the Curve (AUC) of tamoxifen in patients with breast cancer treated with tamoxifen with and without green tea. 2. To compare other tamoxifen and endoxifen pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax), minimal concentration (Ctrough) and time until maximum concentration (tmax) and elimination half-life (t½)). in patients with breast cancer treated with tamoxifen with and without green tea. 3. To evaluate the incidence and severity of side-effects of treatment with tamoxifen in absence and presence of green tea. ;Timepoint(s) of evaluation of this end point: Last visit last patient | — |
Countries
Netherlands
Contacts
Public ContactErasmus MC
Erasmus MC
Outcome results
None listed