Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer
FATTAX
Influence of Body Composition, Total Body Fat and Body Mass Index on the Pharmacokinetics of Docetaxel in Localized Breast Cancer
1 other identifier
interventional
48
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Oct 2023
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2023
CompletedFirst Posted
Study publicly available on registry
May 15, 2023
CompletedStudy Start
First participant enrolled
October 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2027
ExpectedJanuary 2, 2026
December 1, 2025
2.5 years
April 14, 2023
December 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of docetaxel area under courb between obese and lean patients
8 hours after the end of first cycle of docetaxel
Secondary Outcomes (4)
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
Study Arms (1)
Pharmocokinetics blood sample assessment
EXPERIMENTALduring first administration of docetaxel several pharmacokinetics samples will be assessed
Interventions
pharmacokinetics blood sample assessment during the first exposure to docetaxel
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Henri Becquerellead
- Erasmus Medical Centercollaborator
- Universitaire Ziekenhuizen KU Leuvencollaborator
Study Sites (1)
Centre Henri Becquerel
Rouen, 76038, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florian Clatot, Prof
Centre Henri Becquerel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2023
First Posted
May 15, 2023
Study Start
October 25, 2023
Primary Completion
May 2, 2026
Study Completion (Estimated)
May 2, 2027
Last Updated
January 2, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share