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 (May 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
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.
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