The purpose of this study is to determine if pharmacokinetics of docetaxel is modified by the body composition (assessed by the BMI but also by CT-scan) in patients treated by docetaxel as adjuvant treatment of a localized breast cancer
Half of the patients treated for a localized breast cancer are obese or overweighted. Recently published post-hoc analyses of a large randomised trial (BIG-2-98) revealed that BMI could impact the benefit of a docetaxel based chemotherapy, but not of an anthracyclin based chemotherapy. One of the hypothesis is that the distribution volume of hydrophobic drugs, such as docetaxel, may be influenced by the BMI, and more precisely by the amount of total fat. In that context, we aim to assess the docetaxel pharmacokinetics during its first exposure for localized breast cancer, and compare these results according to 3 groups of patients (lean, overweight and obese).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
48
pharmacokinetics blood sample assessment during the first exposure to docetaxel
Centre Henri Becquerel
Rouen, France
RECRUITINGComparison of docetaxel area under courb between obese and lean patients
Time frame: 8 hours after the end of first cycle of docetaxel
Comparison of docetaxel area under courb between overweight and lean patients
Time frame: 8 hours after the end of first cycle of docetaxel
Comparison of docetaxel area under courb according to BMI versus body composition (assessed by CT scan)
Time frame: 8 hours after the end of first cycle of docetaxel
Interrelationship of docetaxel area under courb and docetaxel induced side effects
Time frame: 3 months after first cycle of docetaxel
Interrelationship between of body composition and leptine/adiponectine rates
Time frame: 8 hours after the end of first cycle of docetaxel
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.