Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer (FATTAX)

December 29, 2025 updated by: Centre Henri Becquerel

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Collaborators

Universitaire Ziekenhuizen KU Leuven
Erasmus Medical Center

Investigators

  • Principal Investigator: Florian Clatot, Prof, Centre Henri Becquerel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2023

Primary Completion (Estimated)

May 2, 2026

Study Completion (Estimated)

May 2, 2027

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB22.03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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