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.

Recruiting Phase 4 Interventional Study
Locally Advanced or Metastatic Breast Cancers
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Basic Science
Participants needed
210 (estimated)
Sponsor
Institut Claudius Regaud · Other
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About This Trial
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) b…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Women (or men) aged ≥ 18 years on the day of signing the informed consent with histologically proven breast cancer. 2. Metastatic or locally advanced breast cancer with overexpression/amplification HER2 (IHC +++ or ++ and positive-hybridation in situ) or low HER2 expression (…
Contacts

Florence DALENC, MD, Prof

+33531155104

dalenc.florence@iuct-oncopole.fr

CONTACT