Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer

Breast Cancer Clinical Trial

— FATTAX  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05858398
• Other study ID #: CHB22.03
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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