Clinical trial
Influence of Body Composition, Total Body Fat and Body Mass Index on the Pharmacokinetics of Docetaxel in Localized Breast Cancer
Name
CHB22.03
Description
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 arms
Trial start
2023-05-30
Estimated PCD
2025-05-02
Trial end
2026-05-02
Status
Not yet recruiting
Treatment
pharmacokinetics blood sample assessment
pharmacokinetics blood sample assessment during the first exposure to docetaxel
Arms:
Pharmocokinetics blood sample assessment
Size
48
Primary endpoint
Comparison of docetaxel area under courb between obese and lean patients
8 hours after the end of first cycle of docetaxel
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}
Updated at
2023-05-15
1 organization
1 product
1 indication
Organization
Centre Henri BecquerelIndication
Breast Cancer