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

NCT06830382 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

  • Breast Cancer Stage IV
  • HER2-low Breast Cancer
  • Molecular Imaging

Interventions

DIAGNOSTIC_TEST

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

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

Sponsors & Collaborators

Principal Investigators

  • Renske Altena, MD PhD · Karolinska Institutet

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-03
Primary Completion
2030-04-01
Completion
2032-04-01

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06830382 on ClinicalTrials.gov