MedTrace Logo

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.

NCT07195344 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-05-05

No results posted yet for this study

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).

Conditions

  • Locally Advanced or Metastatic Breast Cancers

Interventions

BIOLOGICAL

Pharmacokinetics 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.

Sponsors & Collaborators

  • Ligue contre le cancer, France

    collaborator OTHER

  • Institut Claudius Regaud

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2029-10-31
Completion
2029-10-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07195344 on ClinicalTrials.gov