Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Henri Becquerel
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Woman older than
Early breast cancer
CT-scan of less than 3 months, including L3 level
Indication of docetaxel at 100 mg/m² as adjuvant CT
Disqualifiers
HER2 amplified or triple negative tumors
Pregnant or breastfeeding women
Patients under guardianship or curatorship
Concomitant administration of another cytotoxic drug or targeted therapy
Trial design
Design model
Single group
Treatments tested in this trial
pharmacokinetics blood sample assessment
Biological/Vaccinepharmacokinetics blood sample assessment during the first exposure to docetaxel
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Pharmocokinetics blood sample assessmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Comparison of docetaxel area under courb between obese and lean patients
Time frame
8 hours after the end of first cycle of docetaxelSecondary outcomes
1
Comparison of docetaxel area under courb between overweight and lean patients
Time frame
8 hours after the end of first cycle of docetaxel2
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 docetaxel3
Interrelationship of docetaxel area under courb and docetaxel induced side effects
Time frame
3 months after first cycle of docetaxel4
Interrelationship between of body composition and leptine/adiponectine rates
Time frame
8 hours after the end of first cycle of docetaxelSponsors and contacts
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Centre Henri Becquerel
Lead sponsor
Erasmus Medical Center
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
Source ClinicalTrials.gov