Image

Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer

Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer

Recruiting
18 years and older
Female
Phase N/A

Powered by AI

Overview

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).

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

Study details
    Breast Cancer

NCT05858398

Centre Henri Becquerel

1 February 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.