How body fat affects docetaxel levels in early breast cancer
Influence of Body Composition, Total Body Fat and Body Mass Index on the Pharmacokinetics of Docetaxel in Localized Breast Cancer
NA · Centre Henri Becquerel · NCT05858398
This trial tests whether body composition measured by BMI and CT scan changes how docetaxel is distributed in adult women receiving adjuvant chemotherapy for localized breast cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Henri Becquerel (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rouen) |
| Trial ID | NCT05858398 on ClinicalTrials.gov |
What this trial studies
Researchers will take blood samples during the first docetaxel exposure to measure drug pharmacokinetics and compare results across three groups (lean, overweight, obese). Body composition will be quantified using BMI and CT-scan analysis at the L3 level to estimate total fat. Patients with HER2-amplified or triple-negative tumors and those receiving other concurrent cytotoxic or targeted therapies are excluded. The goal is to link measured drug exposure to body fat measures and inform whether dosing adjustments might be needed by body composition.
Who should consider this trial
Good fit: Adult women with localized early breast cancer who are planned to receive adjuvant docetaxel at 100 mg/m² and who have a CT scan including the L3 level done within three months are ideal candidates.
Not a fit: Patients with HER2-amplified or triple-negative tumors, pregnant or breastfeeding women, those under guardianship, or patients receiving concurrent or recent other cytotoxic/targeted therapies are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could help personalize docetaxel dosing based on a patient’s body fat to reduce side effects and improve treatment effectiveness.
How similar studies have performed: Post-hoc analyses from a large randomized trial (BIG-2-98) suggested BMI may affect benefit from docetaxel, but direct pharmacokinetic studies linking CT-measured fat to docetaxel exposure remain limited and are relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rouen
- Centre Henri Becquerel — Rouen, France (RECRUITING)
Study contacts
- Principal investigator: Florian Clatot, Prof — Centre Henri Becquerel
- Study coordinator: Florian Clatot, Prof
- Email: florian.clatot@chb.unicancer.fr
- Phone: +33232082231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, breast cancer, body composition, docetaxel, pharmacokinetics