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Influence des caractéristiques morphologiques sur la pharmacocinétique et la toxicité du trastuzumab-déruxtécan chez des patients ayant un cancer du sein métastatique (TDXdose)
EU CTIS ID: 2025-522656-68-00
What this study is testing
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).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Women (or men) aged ≥ 18 years on the day of signing the informed consent with histologically proven breast cancer.
- 10. Patient affiliated to a Social Health Insurance in France.
- 2. Metastatic or locally advanced breast cancer with overerexpression/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.
You likely can't join if
- 1. Peripheral venous access making blood samples difficult.
- 10. Patient with severe hepatic impairment defined by TGO and/or TGP > 5 x ULN and Total bilirubin > 1.5 x ULN.
- 2. Patient unable to receive T-DXd treatment at a dose of 5.4 mg/kg in cycle 1 (whatever the reason).
- 3. Patient 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. Patient 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.
See the full eligibility criteria
Who can join
- 1. Women (or men) aged ≥ 18 years on the day of signing the informed consent with histologically proven breast cancer.
- 10. Patient affiliated to a Social Health Insurance in France.
- 2. Metastatic or locally advanced breast cancer with overerexpression/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.
What rules you out
- 1. Peripheral venous access making blood samples difficult.
- 10. Patient with severe hepatic impairment defined by TGO and/or TGP > 5 x ULN and Total bilirubin > 1.5 x ULN.
- 2. Patient unable to receive T-DXd treatment at a dose of 5.4 mg/kg in cycle 1 (whatever the reason).
- 3. Patient 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. Patient 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.