Clinical trial · Interventional
Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer
Influence of Body Composition, Total Body Fat and Body Mass Index on the Pharmacokinetics of Docetaxel in Localized Breast Cancer
NCT05858398CI-TRIAL-00100030FATTAXrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pharmacokinetics blood sample assessment | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pharmocokinetics blood sample assessment
- description
- during first administration of docetaxel several pharmacokinetics samples will be assessed
- interventionNames
- Biological: pharmacokinetics blood sample assessment
Primary outcomes (1)
- measure
- Comparison of docetaxel area under courb between obese and lean patients
- timeFrame
- 8 hours after the end of first cycle of docetaxel
Secondary outcomes (4)
- measure
- Comparison of docetaxel area under courb between overweight and lean patients
- timeFrame
- 8 hours after the end of first cycle of docetaxel
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.