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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05858398
Other study ID # CHB22.03
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 30, 2023
Est. completion date May 2, 2026

Study information

Verified date May 2023
Source Centre Henri Becquerel
Contact Florian Clatot, Prof
Phone +33232082231
Email florian.clatot@chb.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Half of the patients treated for a localized breast cancer are obese or overweighted. Recently published post-hoc analyses of a large randomised trial (BIG-2-98) revealed that BMI could impact the benefit of a docetaxel based chemotherapy, but not of an anthracyclin based chemotherapy. 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 48
Est. completion date May 2, 2026
Est. primary completion date May 2, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
pharmacokinetics blood sample assessment
pharmacokinetics blood sample assessment during the first exposure to docetaxel

Locations

Country Name City State
France Centre Henri Becquerel Rouen

Sponsors (3)

Lead Sponsor Collaborator
Centre Henri Becquerel Erasmus Medical Center, Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of docetaxel area under courb between obese and lean patients 8 hours after the end of first cycle of docetaxel
Secondary Comparison of docetaxel area under courb between overweight and lean patients 8 hours after the end of first cycle of docetaxel
Secondary Comparison of docetaxel area under courb according to BMI versus body composition (assessed by CT scan) 8 hours after the end of first cycle of docetaxel
Secondary Interrelationship of docetaxel area under courb and docetaxel induced side effects 3 months after first cycle of docetaxel
Secondary Interrelationship between of body composition and leptine/adiponectine rates 8 hours after the end of first cycle of docetaxel
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