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Study identifier: NCT07195344 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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.

Condition: Locally Advanced or Metastatic Breast Cancers  ·  Sponsor: Institut Claudius Regaud

PhasePhase 4
Planned participants210
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Florence DALENC, MD, Prof  ·  +33531155104  ·  dalenc.florence@iuct-oncopole.fr

Always discuss trial participation with your own doctor first.

Locations (11)

Institut de Cancérologie de l'Ouest - Site AngersAngers, FranceNot Yet Recruiting
Centre Georges François LeclercDijon, FranceNot Yet Recruiting
Centre Oscar LambretLille, FranceRecruiting
Institut Paoli CalmettesMarseille, FranceNot Yet Recruiting
CHU de NîmesNîmes, FranceRecruiting
Institut Curie - Site ParisParis, FranceNot Yet Recruiting
Centre Eugène MarquisRennes, FranceRecruiting
Institut de Cancérologie de l'Ouest - Site Saint HerblainSaint-Herblain, FranceNot Yet Recruiting
Centre Paul StraussStrasbourg, FranceRecruiting
IUCT-OToulouse, FranceRecruiting
Institut de Cancérologie de LorraineVandœuvre-lès-Nancy, FranceNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07195344