RecruitingNCT06830382

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

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


Sponsor

Renske Altena

Enrollment

70 participants

Start Date

Oct 3, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special PET imaging scan that detects HER2 (a protein linked to cancer cell growth) to identify which patients with metastatic or advanced breast cancer are most likely to benefit from HER2-targeted antibody-drug conjugate therapy. The goal is to make cancer treatment more precise by matching patients to the right therapy based on their tumor's HER2 activity. **You may be eligible if...** - You are a woman aged 18 or older - You have metastatic or locally advanced breast cancer that has progressed after at least one line of chemotherapy, or has relapsed within 6 months after completing adjuvant chemotherapy - You have at least one metastatic lesion of 10 mm or larger that can be biopsied (or have a recent biopsy available) - You are willing and able to give written consent **You may NOT be eligible if...** - Your breast cancer lesions are too small or inaccessible for biopsy - You have had prior treatment with the HER2-targeting therapies being tested in this study - You have serious organ problems that would make treatment or imaging unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPositron emission tomografy with [68Ga]Ga-ABY-025

Investigational Medicinal product (IMP):\[68Ga\]Ga-ABY-025 (all patients)


Locations(1)

Karolinska University hospital

Solna, Sweden

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NCT06830382


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