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Compares treatment options for Locally Advanced or Metastatic Breast Cancers
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.
ClinicalTrials.gov ID: NCT07195344
What this study is testing
What is Pharmacokinetics blood samples?
Pharmacokinetics blood samples is an investigational medicine, being studied as a potential treatment for locally advanced or metastatic breast cancers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Women (or men) aged ≥ 18 years on the day of signing the informed consent with histologically proven breast cancer.
- Metastatic or locally advanced breast cancer with overexpression/amplification HER2 (IHC +++ or ++ and positive-hybridation in situ) or low HER2...
- Patient eligible for Trastuzumab-Deruxtecan (T-DXd).
- Concomitant administration of pertuzumab may be accepted in case of approval in first line for HER2- overexpressed/amplified locally advanced or...
- Female people 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
- Peripheral venous access making blood samples difficult.
- Patients unable to receive T-DXd treatment at a dose of 5.4 mg/kg in cycle 1 (whatever the reason)
- Patients with known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or...
- Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with...
- Patient pregnant, or breast-feeding.
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of...
See the full eligibility criteria
- Women (or men) aged ≥ 18 years on the day of signing the informed consent with histologically proven breast cancer.
- 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...
- Patient eligible for Trastuzumab-Deruxtecan (T-DXd).
- Concomitant administration of pertuzumab may be accepted in case of approval in first line for HER2- overexpressed/amplified locally advanced or metastatic breast cancer.
- Female people of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study treatment.
- Female people 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...
- Male people 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...
- Signed written informed consent.
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.
- Patient affiliated to a Social Health Insurance in France.
- Peripheral venous access making blood samples difficult.
- Patients unable to receive T-DXd treatment at a dose of 5.4 mg/kg in cycle 1 (whatever the reason)
- 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...
- Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.
- Patient pregnant, or breast-feeding.
- 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.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
- Concurrent participation in an experimental drug study.
- 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.
- Patient with severe hepatic impairment defined by TGO and/or TGP \> 5 x ULN and Total bilirubin \> 1.5 x ULN.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Dijon, France
- Lille, France
- Marseille, France
- Nîmes, France
- Paris, France
- Rennes, France
- Saint-Herblain, France
- Strasbourg, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Dijon, France; Lille, France; Marseille, France; Nîmes, France; Paris, France and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.