Study of Usefulness of Genotyping to Predict Docetaxel Exposure and Adverse Events
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
Twenty patients with verified high risk breast cancer will be included in the study. Patients
will receive three cycles of docetaxel followed by three cycles of CEF for their adjuvant
treatment. The phenotype of CYP3A and the genotype of CYP3A5 and MDR1 will be assessed. Also
the effect of docetaxel in the activity of CYP3A will be measured by peroral midazolam.
Primary Object:
The primary object of this study is to define, if it is possible to predict the clearance
and/ or toxicity of docetaxel by assessing
- activity of CYP3A4 by midazolam test (CYP3A4 phenotype)
- CYP3A5 genotype
- MDR1 genotype
Secondary object:
The secondary object of this study is to define whether the treatment with docetaxel alters
the activity of CYP3A4 enzyme in previously untreated breast cancer patients.
Details
Lead Sponsor:
University of Turku
Collaborators:
medbase Oy Ltd Sanofi Turku University Hospital Vaasa Central Hospital, Vaasa, Finland