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.
| NCT ID | NCT07195344 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Institut Claudius Regaud |
| Condition | Locally Advanced or Metastatic Breast Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 210 participants in total. It began in 2025-10-15 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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 (IHC + or ++ and negative-hybridation in situ) and may be ultra-low (in first line, in case of approval). 3. Patient eligible for Trastuzumab-Deruxtecan (T-DXd). 4. Concomitant administration of pertuzumab may be accepted in case of approval in first line for HER2- overexpressed/amplified locally advanced or metastatic breast cancer. 5. Female subjects of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study treatment. 6. Female subjects of childbearing potential must be willing to follow at least one method of contraception or be surgically sterile, or abstain from heterosexual activity for the duration of the study and until 7 months after the last dose of study treatment. Subjects of childbearing potential are those who have not been surgically sterilized and who had menstruation in the last 12 months. Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception. 7. Male subjects must agree to use at least one method of contraception for the duration of the study and until 4 months after the last dose of study treatment. Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception. 8. Signed written informed consent. 9. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol. 10. Patient affiliated to a Social Health Insurance in France. Exclusion Criteria: 1. Peripheral venous access making blood samples difficult. 2. Patients unable to receive T-DXd treatment at a dose of 5.4 mg/kg in cycle 1 (whatever the reason) 3. Patients with known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 4. Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study. 5. Patient pregnant, or breast-feeding. 6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure. 7. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice). 8. Concurrent participation in an experimental drug study. 9. Patient with a known history of hypersensitivity to the active substance of T-DXd or to any of the excipients listed in the SmPC of T-DXd. 10. Patient with severe hepatic impairment defined by TGO and/or TGP \> 5 x ULN and Total bilirubin \> 1.5 x ULN.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07195344 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced or Metastatic Breast Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07195344 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07195344 currently recruiting?
Yes, NCT07195344 is actively recruiting participants. Contact the research team at dalenc.florence@iuct-oncopole.fr for enrollment information.
Where is the NCT07195344 trial being conducted?
This trial is being conducted at Angers, France, Dijon, France, Lille, France, Marseille, France and 7 additional locations.
Who is sponsoring the NCT07195344 clinical trial?
NCT07195344 is sponsored by Institut Claudius Regaud. The trial plans to enroll 210 participants.
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