NL-OMON48342
Completed
Phase 2
Study on the possible pharmacokinetic interaction between grean tea supplements and tamoxifen in patients with breast cancer. the TEA study - TEA study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 14
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Exclusion Criteria
- •1\. Patients with known impaired drug absorption (e.g. gastrectomy and
- •achlorhydria)
- •2\. Patients with an active gastric ulcer
- •3\. 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)
- •4\. A CYP2D6 poor metabolizer or ultra\-rapid metabolizer phenotype based on
- •CYP2D6 genotyping outcome
Outcomes
Primary Outcomes
Not specified
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