HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRenske Altena
About this trial
This is a prospective, multi-center, open-label, exploratory diagnostic phase II imaging trial for patients with metastatic breast cancer with at least one line of systemic therapy.
The overarching aim of the HER2-Ex PET trial is to study the role of precision imaging utilizing positron emission tomography (PET) with the HER2-specific tracer \[68Ga\]Ga-ABY-025 (hereafter referred to as HER2-PET) in enhancing treatment planning for patients with metastatic HER2-expressing breast cancer Patients will be allocated based on HER2-status on PET and biopsy. Patients with HER2-expressing lesions in a fresh or archived tumour biopsy will be treated with T-DXd.
The study hypothesis is that PET/CT precision imaging with a contemporary HER2-radiotracer (\[68Ga\]Ga-ABY-025) can be used and can lead to a potentially better identification of patients who benefit from T-DXd treatment, thereby achieving improved treatment responses as well as fewer side effects. This study's diagnostic approach provides a more individualized treatment strategy. Additionally, this study can potentially give us a better biological understanding of HER2-expressing mBC.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Positron emission tomografy with [68Ga]Ga-ABY-025
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Renske Altena
Lead sponsor
Karolinska University Hospital
Sponsor institution
Karolinska Institutet
Collaborator
Affibody
Collaborator
Source ClinicalTrials.gov