HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC

Launched by RENSKE ALTENA · Feb 14, 2025

Keywords

ClinConnect Summary

The HER2-PET trial is a research study aimed at improving treatment for women with advanced breast cancer that expresses a protein called HER2. This trial will use a special imaging technique called PET (Positron Emission Tomography) with a tracer that helps to see HER2 levels in the body. The goal is to identify patients who are most likely to benefit from a specific treatment called T-DXd, which could lead to better results and fewer side effects. To be part of this study, women must be at least 18 years old, have metastatic breast cancer that has progressed after at least one line of treatment, and have a suitable tumor for biopsy.

Participants in the trial can expect to undergo imaging tests and biopsies to assess their HER2 status, and those who qualify will receive the T-DXd treatment. The study is currently not recruiting participants, but it aims to provide more personalized treatment options based on the individual’s specific cancer characteristics. It's important for potential participants to know they will need to give informed consent and may need to follow specific guidelines regarding contraception during the study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female patients 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 three months old and without exposition to systemic anti-cancer 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 testing prior to each administration of the IMP is obligatory.
• Exclusion Criteria:
• • 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.
• • any anticoagulants or antiplatelet treatment that cannot be temporarily paused