OncoMatch/Clinical Trials/NCT07195344
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.
Is NCT07195344 recruiting? Yes, currently enrolling (Jun 2026). This Phase 4 trial studies Pharmacokinetics blood samples for locally advanced or metastatic breast cancers.
Treatment: Pharmacokinetics blood samples — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Allowed: HER2 (ERBB2) overexpression
overexpression/amplification HER2 (IHC +++ or ++ and positive-hybridation in situ)
Allowed: HER2 (ERBB2) amplification
overexpression/amplification HER2 (IHC +++ or ++ and positive-hybridation in situ)
Allowed: HER2 (ERBB2) low expression
low HER2 expression (IHC + or ++ and negative-hybridation in situ) and may be ultra-low (in first line, in case of approval)
Disease stage
Required: Stage III, IV
Lab requirements
Liver function
severe hepatic impairment defined by TGO and/or TGP > 5 x ULN and Total bilirubin > 1.5 x ULN [excluded]
Patient with severe hepatic impairment defined by TGO and/or TGP > 5 x ULN and Total bilirubin > 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07195344 currently recruiting?
Yes, this trial is currently recruiting patients.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify