Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: pharmacokinetics blood sample assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmocokinetics blood sample assessment<br>during first administration of docetaxel several pharmacokinetics samples will be assessed | Biological: pharmacokinetics blood sample assessment<br>* pharmacokinetics blood sample assessment during the first exposure to docetaxel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of docetaxel area under courb between obese and lean patients |  | 8 hours after the end of first cycle of docetaxel | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body composition, breast cancer, docetaxel, pharmacokinetics