Clinical trial NCT05858398: Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer
Official title: Influence of Body Composition, Total Body Fat and Body Mass Index on the Pharmacokinetics of Docetaxel in Localized Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
body composition
docetaxel
pharmacokinetics
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Universitaire Ziekenhuizen KU Leuven
First posted: 2023-05-15
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Comparison of docetaxel area under courb between obese and lean patients
timeFrame: 8 hours after the end of first cycle of docetaxel
Secondary outcomes:
measure: Comparison of docetaxel area under courb between overweight and lean patients
timeFrame: 8 hours after the end of first cycle of docetaxel
measure: Comparison of docetaxel area under courb according to BMI versus body composition (assessed by CT scan)
timeFrame: 8 hours after the end of first cycle of docetaxel
measure: Interrelationship of docetaxel area under courb and docetaxel induced side effects
timeFrame: 3 months after first cycle of docetaxel
measure: Interrelationship between of body composition and leptine/adiponectine rates
timeFrame: 8 hours after the end of first cycle of docetaxel
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Florian Clatot, Prof
role: PRINCIPAL_INVESTIGATOR
References: