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Trial Title:
Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer
NCT ID:
NCT05858398
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
body composition
docetaxel
pharmacokinetics
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
pharmacokinetics blood sample assessment
Description:
pharmacokinetics blood sample assessment during the first exposure to docetaxel
Arm group label:
Pharmocokinetics blood sample assessment
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).
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Henri Becquerel
Address:
City:
Rouen
Zip:
76038
Country:
France
Contact:
Last name:
Florian Clatot, Prof
Phone:
+33232082231
Email:
florian.clatot@chb.unicancer.fr
Contact backup:
Last name:
Doriane Richard, PhD
Phone:
+33232082985
Email:
doriane.richard@chb.unicancer.fr
Start date:
May 30, 2023
Completion date:
May 2, 2026
Lead sponsor:
Agency:
Centre Henri Becquerel
Agency class:
Other
Collaborator:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Source:
Centre Henri Becquerel
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05858398
