Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer
NCT ID: NCT05858398
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2023-10-25
2027-05-02
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Pharmocokinetics blood sample assessment
during first administration of docetaxel several pharmacokinetics samples will be assessed
pharmacokinetics blood sample assessment
pharmacokinetics blood sample assessment during the first exposure to docetaxel
Interventions
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pharmacokinetics blood sample assessment
pharmacokinetics blood sample assessment during the first exposure to docetaxel
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Erasmus Medical Center
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Centre Henri Becquerel
OTHER
Responsible Party
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Principal Investigators
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Florian Clatot, Prof
Role: PRINCIPAL_INVESTIGATOR
Centre Henri Becquerel
Locations
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Centre Henri Becquerel
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHB22.03
Identifier Type: -
Identifier Source: org_study_id
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