Breast Cancer
Conditions
Keywords
breast cancer, body composition, docetaxel, pharmacokinetics
Brief summary
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
Detailed description
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).
Interventions
BIOLOGICALpharmacokinetics blood sample assessment
pharmacokinetics blood sample assessment during the first exposure to docetaxel
Sponsors
Erasmus Medical Center
Universitaire Ziekenhuizen KU Leuven
Centre Henri Becquerel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* HER2 amplified or triple negative tumors * Pregnant or breastfeeding women * Patients under guardianship or curatorship * Concomitant administration of another cytotoxic drug or targeted therapy * Psychosocial disorder * Administration of another cytotoxic drug or targeted therapy within 20 days prior to blood collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of docetaxel area under courb between obese and lean patients | 8 hours after the end of first cycle of docetaxel |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of docetaxel area under courb between overweight and lean patients | 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) | 8 hours after the end of first cycle of docetaxel |
| Interrelationship of docetaxel area under courb and docetaxel induced side effects | 3 months after first cycle of docetaxel |
| Interrelationship between of body composition and leptine/adiponectine rates | 8 hours after the end of first cycle of docetaxel |
Countries
France
Contacts
Primary ContactFlorian Clatot, Prof
Backup ContactDoriane Richard, PhD
Outcome results
None listed