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A multicentre, prospective, open-label study with [68Ga]Ga-ABY-025 PET-imaging to characterize HER2-expression and explore the therapy-predictive value for HER2-antibody drug conjugates in patients with metastatic breast cancer (HER2-Ex PET)
EU CTIS ID: 2024-512721-89-00
What this study is testing
To investigate the therapy-predictive role of HER2-PET for the clinical benefit of treatment with T-DXd in patients with HER2-expressing mBC
- Therapeutic exploratory (Phase II)
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
- Female age ≥18 years
- Metastatic or locally advanced breast cancer with disease progression after ≥ 1 line of chemotherapy in the palliative setting, or with disease relapse within six months after completion of (neo-) adjuvant chemotherapy
- The patient must be able and willing to provide written consent to participate in the study
- At least one metastatic lesion ≥ 10 mm is available for biopsy. o Exception can be made when a recent biopsy is available (no more than 12 months old and without exposition to HER2-targeted therapy or local radiotherapy to the specific lesion).
- At least one additional metastatic index lesion ≥ 10 mm for evaluation of treatment effect (according to RECIST v1.1)
- WHO performance status ≤ 2
You likely can't join if
- Contra-indications for treatment for trastuzumab deruxtecan and inability to undergo this treatment as per local treatment routines
- A previously documented metastatic tumor biopsy that was HER2-positive (IHC 3+ and/or HER2 gene amplification)
- Other manifest malignancies except for basal cell carcinoma of the skin
- Inadequate cardiac, renal, bone marrow or liver function
- Patients with increased risk of complications from biopsies, i.e. increased risk of bleeding, defined as; prothrombin time test (INR value) >1.4, platelet count <70 (109/l), activated partial thromboplastin time (APTT) >30s, known bleeding disorders such as haemophilia, von Willebrand disease or platelet disorders or any anticoagulants or antiplatelet treatment that cannot be temporarily paused
See the full eligibility criteria
Who can join
- Female age ≥18 years
- Metastatic or locally advanced breast cancer with disease progression after ≥ 1 line of chemotherapy in the palliative setting, or with disease relapse within six months after completion of (neo-) adjuvant chemotherapy
- The patient must be able and willing to provide written consent to participate in the study
- At least one metastatic lesion ≥ 10 mm is available for biopsy. o Exception can be made when a recent biopsy is available (no more than 12 months old and without exposition to HER2-targeted therapy or local radiotherapy to the specific lesion).
- At least one additional metastatic index lesion ≥ 10 mm for evaluation of treatment effect (according to RECIST v1.1)
- WHO performance status ≤ 2
- Expected survival > 12 weeks
- Contraceptives: Females of child-bearing potential must agree to use adequate contraception prior to study entry, , for the duration of the study treatment phase and for six months after the last dose of [68Ga]Ga-ABY-025. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period. Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If a female participant is of child-bearing potential (females are considered not of childbearing potential if they are at least one year postmenopausal and/or surgically sterile), she must have a documented negative serum pregnancy test before [68Ga]Ga-ABY-025 administration. Pregnancy testing prior to each administration of the IMP is obligatory.
What rules you out
- Contra-indications for treatment for trastuzumab deruxtecan and inability to undergo this treatment as per local treatment routines
- A previously documented metastatic tumor biopsy that was HER2-positive (IHC 3+ and/or HER2 gene amplification)
- Other manifest malignancies except for basal cell carcinoma of the skin
- Inadequate cardiac, renal, bone marrow or liver function
- Patients with increased risk of complications from biopsies, i.e. increased risk of bleeding, defined as; prothrombin time test (INR value) >1.4, platelet count <70 (109/l), activated partial thromboplastin time (APTT) >30s, known bleeding disorders such as haemophilia, von Willebrand disease or platelet disorders or any anticoagulants or antiplatelet treatment that cannot be temporarily paused
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 female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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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.