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NCT Number: NCT05858398

Influence of Body Composition on Chemotherapy Outcomes 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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pharmacokinetics blood sample assessment

Biological

pharmacokinetics blood sample assessment during the first exposure to docetaxel

Primary outcomes

  1. Comparison of docetaxel area under courb between obese and lean patients

    Time frame: 8 hours after the end of first cycle of docetaxel

Secondary outcomes

  1. Comparison of docetaxel area under courb between overweight and lean patients

    Time frame: 8 hours after the end of first cycle of docetaxel

  2. 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

  3. Interrelationship of docetaxel area under courb and docetaxel induced side effects

    Time frame: 3 months after first cycle of docetaxel

  4. Interrelationship between of body composition and leptine/adiponectine rates

    Time frame: 8 hours after the end of first cycle of docetaxel

Study contacts

Contact information is provided by the study sponsor or research team.

Doriane Richard, PhD

CONTACT

[email protected]

+33232082985

Florian Clatot, Prof

CONTACT

[email protected]

+33232082231

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Collaborators

  • Erasmus Medical Center
  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

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

Acronym: FATTAX

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 15, 2023
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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