Study on the effect of green tea on the exposure to tamoxifen in patients with breast cancer the TEA study

Phase 1

• Conditions: Breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002910-37-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-07
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 14

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 <5.0 upper limit of normal (ULN)
-bilirubin <1.5 (ULN)
-GFR > 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>3.To evaluate the incidence and severity of side-effects of treatment with tamoxifen in absence and presence of green tea.<br>;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 Outcome Measures

Name	Time	Method
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.<br>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.<br>3.To evaluate the incidence and severity of side-effects of treatment with tamoxifen in absence and presence of green tea.<br>;Timepoint(s) of evaluation of this end point: Last visit last patient