Spots Global Cancer Trial Database for Study of Usefulness of Genotyping to Predict Docetaxel Exposure and Adverse Events
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Trial Identification
Brief Title: Study of Usefulness of Genotyping to Predict Docetaxel Exposure and Adverse Events
Official Title: Activity of CYP3A and Genotypes of CYP3A5 and MDR1 as Predictors of the Clearance and Adverse Effects of Docetaxel, and the Effect of Docetaxel to CYP3A Activity in Previously Untreated Breast Cancer Patients
Study ID: NCT01110291
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Turku University Hospital, Turku, , Finland
Contact Details
Name: Johanna Hilli, MD, PhD
Affiliation: Department of Pharmacology, Drug Development and Therapeutics, University of Turku, Turku, Finland
Role: PRINCIPAL_INVESTIGATOR
Name: Liisa Sailas, MD
Affiliation: Department of Oncology, Vaasa Central Hospital, Vaasa, Finland
Role: STUDY_CHAIR
Name: Sirkku Jyrkkiö, MD, PhD
Affiliation: Department of Oncology and Radiotherapy, Turku University Hospital, Turku, Finland
Role: STUDY_CHAIR
Name: Seppo Pyrhönen, MD, PhD
Affiliation: Department of Oncology and Radiotherapy, Turku University Hospital, Turku, Finland
Role: STUDY_CHAIR
Name: Kari Laine, MD, PhD
Affiliation: medbase Oy Ltd, Turku, Finland
Role: STUDY_CHAIR
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