Actively Recruiting
HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC
Led by Renske Altena · Updated on 2025-11-20
70
Participants Needed
1
Research Sites
338 weeks
Total Duration
On this page
Sponsors
R
Renske Altena
Lead Sponsor
K
Karolinska Institutet
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients age 6518 years
- Metastatic or locally advanced breast cancer with disease progression after 651 line of chemotherapy in the palliative setting, or disease relapse within six months after (neo-) adjuvant chemotherapy
- Able and willing to provide written consent to participate
- At least one metastatic lesion 6510 mm available for biopsy, or a recent biopsy no more than 12 months old without HER2-targeted therapy or radiotherapy to that lesion
- At least one additional metastatic lesion 6510 mm for evaluating treatment effect
- WHO performance status 642
- Expected survival longer than 12 weeks
- Females of child-bearing potential must agree to use adequate contraception during and for six months after study treatment and have negative pregnancy tests before each study drug administration
You will not qualify if you...
- Contraindications to trastuzumab deruxtecan treatment or inability to receive it per local routine
- Previously documented metastatic tumor biopsy that was HER2-positive (IHC 3+ and/or HER2 gene amplification)
- Other active cancers except basal cell carcinoma of the skin
- Inadequate heart, kidney, bone marrow, or liver function
- Increased risk of complications from biopsies, including bleeding disorders or abnormal blood clotting tests
- Use of anticoagulants or antiplatelet drugs that cannot be safely paused
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Karolinska University hospital
Solna, Sweden, 17176
Actively Recruiting
Research Team
T
Thuy Tran, Associate Prof, PharmD, PhD
CONTACT
R
Renske Altena, Associate Professor, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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