How body fat affects docetaxel levels in early breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.