RecruitingPhase 4NCT07195344

Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.

Influence of Patient's Morphological Characteristics on Pharmacokinetic and Toxicity of Trastuzumab-Deruxtecan Administered for Metastatic Breast Cancers


Sponsor

Institut Claudius Regaud

Enrollment

210 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, prospective, non-randomized, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer according to their BMI. The primary objective is to compare plasma exposition of the payload (free-DXd) between overweight or obese (BMI\>25) and normal weight (BMI≤25) breast cancer patients during the first 3 cycles of Trastuzumab-Deruxtecan (T-DXd). A total of 210 patients will have to be enrolled in this study with the following repartition: N = 105 patients with a BMI ≤ 25 (normal weight patients). N = 105 patients with a BMI \> 25 (overweight or obese patients) with at least 30 obese patients (BMI\>30).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether body weight (BMI) affects how much of the active chemotherapy component (called free-DXd) from the breast cancer drug trastuzumab deruxtecan (T-DXd) is absorbed into the bloodstream, to understand if dosing should be adjusted for people with higher or lower body weight. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of metastatic or locally advanced breast cancer - Your cancer has HER2 overexpression or amplification, low HER2 expression, or ultra-low HER2 expression - You are already eligible for and will be receiving trastuzumab deruxtecan (T-DXd) as part of your treatment - Female participants of childbearing potential must have a negative pregnancy test within 72 hours before treatment **You may NOT be eligible if...** - You do not have a confirmed breast cancer diagnosis - You are not eligible to receive T-DXd per your doctor's assessment - Your blood tests, organ function, or pregnancy status do not meet the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALPharmacokinetics blood samples

Blood samples will be collected at different time points during the first four treatment cycles and at the end of T-DXd treatment or at 24 months after inclusion in case of T-DXd continuation beyond this time period.


Locations(11)

Institut de Cancérologie de l'Ouest - Site Angers

Angers, France

Centre Georges François Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

Institut Paoli Calmettes

Marseille, France

CHU de Nîmes

Nîmes, France

Institut Curie - Site Paris

Paris, France

Centre Eugène Marquis

Rennes, France

Institut de Cancérologie de l'Ouest - Site Saint Herblain

Saint-Herblain, France

Centre Paul Strauss

Strasbourg, France

IUCT-O

Toulouse, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07195344