Actively 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.
Led by Institut Claudius Regaud · Updated on 2026-05-05
210
Participants Needed
11
Research Sites
206 weeks
Total Duration
On this page
Sponsors
I
Institut Claudius Regaud
Lead Sponsor
L
Ligue contre le cancer, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women or men aged 18 years or older with histologically confirmed breast cancer
- Locally advanced or metastatic breast cancer with HER2 overexpression/amplification or low HER2 expression
- Eligible for Trastuzumab-Deruxtecan (T-DXd) treatment
- Concomitant pertuzumab allowed if approved for first-line treatment in HER2-positive cases
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before first treatment dose
- Female participants of childbearing potential must use effective contraception, be surgically sterile, or abstain from heterosexual activity during the study and for 7 months after last dose
- Male participants must use contraception during the study and for 4 months after last dose
- Signed informed consent
- Ability and willingness to comply with study procedures
- Affiliated with Social Health Insurance in France
You will not qualify if you...
- Peripheral venous access that makes blood sampling difficult
- Inability to receive T-DXd treatment at 5.4 mg/kg dose in cycle 1
- Active additional malignancy requiring treatment, except certain skin cancers or in situ cervical cancer
- Significant uncontrolled medical, psychiatric, or surgical conditions interfering with study completion
- Pregnant or breastfeeding
- Psychological, familial, geographic, or social situations preventing informed consent or study compliance
- Legal restrictions such as loss of freedom or legal protection
- Participation in another experimental drug study
- Known hypersensitivity to T-DXd or its excipients
- Severe liver impairment defined by specific lab values (TGO/TGP > 5 x ULN, Total bilirubin > 1.5 x ULN)
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Institut de Cancérologie de l'Ouest - Site Angers
Angers, France
Not Yet Recruiting
2
Centre Georges François Leclerc
Dijon, France
Not Yet Recruiting
3
Centre Oscar Lambret
Lille, France
Actively Recruiting
4
Institut Paoli Calmettes
Marseille, France
Not Yet Recruiting
5
CHU de Nîmes
Nîmes, France
Actively Recruiting
6
Institut Curie - Site Paris
Paris, France
Not Yet Recruiting
7
Centre Eugène Marquis
Rennes, France
Actively Recruiting
8
Institut de Cancérologie de l'Ouest - Site Saint Herblain
Saint-Herblain, France
Not Yet Recruiting
9
Centre Paul Strauss
Strasbourg, France
Actively Recruiting
10
IUCT-O
Toulouse, France
Actively Recruiting
11
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
Research Team
F
Florence DALENC, MD, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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