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.
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