NCT05858398

Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer

Influence of Body Composition, Total Body Fat and Body Mass Index on the Pharmacokinetics of Docetaxel in Localized Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Centre Henri Becquerel · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	pharmacokinetics blood sample assessment	pharmacokinetics blood sample assessment during the first exposure to docetaxel

Timeline

• Start date: 2023-10-25
• Primary completion: 2026-05-02
• Completion: 2027-05-02
• First posted: 2023-05-15
• Last updated: 2026-01-02

Locations

1 site across 1 country: France