Centre Henri Becquerel
Rouen, 76038, France
Location status: Recruiting
Location contact
Doriane Richard, PhD
CONTACT
Florian Clatot, Prof
CONTACT
NCT Number: NCT05858398
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
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Rouen, 76038, France
Location status: Recruiting
Doriane Richard, PhD
CONTACT
Florian Clatot, Prof
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
pharmacokinetics blood sample assessment during the first exposure to docetaxel
Time frame: 8 hours after the end of first cycle of docetaxel
Time frame: 8 hours after the end of first cycle of docetaxel
Time frame: 8 hours after the end of first cycle of docetaxel
Time frame: 3 months after first cycle of docetaxel
Time frame: 8 hours after the end of first cycle of docetaxel
Contact information is provided by the study sponsor or research team.
Doriane Richard, PhD
CONTACT
Florian Clatot, Prof
CONTACT
Centre Henri Becquerel
Other
Influence of Body Composition, Total Body Fat and Body Mass Index on the Pharmacokinetics of Docetaxel in Localized Breast Cancer
Acronym: FATTAX
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