Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Biological: pharmacokinetics blood sample assessment

• Registration Number: NCT05858398
• Lead Sponsor: Centre Henri Becquerel

Brief 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).

Study Timeline

• Study First Submitted: 2023-04-14
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-11
• Last Update Submitted: 2023-05-11
• Study First Posted: 2023-05-15
• Last Update Posted: 2023-05-15
• Study Start: 2023-05-30
• Primary Completion: 2025-05-02
• Study Completion: 2026-05-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmocokinetics blood sample assessment	pharmacokinetics blood sample assessment	during first administration of docetaxel several pharmacokinetics samples will be assessed

Primary Outcome Measures

Name	Time	Method
Comparison of docetaxel area under courb between obese and lean patients	8 hours after the end of first cycle of docetaxel

Secondary Outcome Measures

Name	Time	Method
Comparison of docetaxel area under courb between overweight and lean patients	8 hours after the end of first cycle of docetaxel
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
Interrelationship of docetaxel area under courb and docetaxel induced side effects	3 months after first cycle of docetaxel
Interrelationship between of body composition and leptine/adiponectine rates	8 hours after the end of first cycle of docetaxel

Trial Locations

Locations (1)

Centre Henri Becquerel; 🇫🇷 Rouen, France