Recruiting

HER2-expression PET Imaging in Metastatic Breast Cancer

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2025
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Summary

Principal SponsorRenske Altena
Study ContactThuy Tran, Associate Prof, PharmD, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 3, 2025

Actual date on which the first participant was enrolled.

This clinical study is designed for female patients with metastatic breast cancer, focusing on understanding the HER2 protein's expression in cancer cells. It aims to explore how a specific imaging technique, using a tracer called [68Ga]Ga-ABY-025, might predict the effectiveness of HER2-targeting treatments. The study targets women whose tumors are known to be non-HER2 positive or have an unknown HER2 status. It includes those whose disease has progressed after previous chemotherapy or within six months of completing treatment for primary breast cancer. This study is crucial as it could lead to better-targeted treatments for patients with this type of cancer, potentially improving outcomes. Participants in the study will first undergo a special scan called HER2-PET and a tumor biopsy, which helps determine the presence and extent of HER2 proteins. If the HER2 protein is present in the tumor biopsy, patients will receive treatment with a drug called T-DXd. The effectiveness of this treatment is evaluated with a follow-up HER2-PET scan after 9-12 weeks. An additional HER2-PET scan and biopsy may be done if the disease progresses while on T-DXd. This process helps researchers evaluate the treatment's impact and potentially predict the responsiveness of such therapies in managing metastatic breast cancer.

Official TitleA 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
NCT06830382
Principal SponsorRenske Altena
Study ContactThuy Tran, Associate Prof, PharmD, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

8 inclusion criteria required to participate
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 12 months old and without exposition to HER2-targeted therapy or local radiotherapy to the specific lesion).

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5 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Karolinska University hospital

Solna, SwedenOpen Karolinska University hospital in Google Maps
Recruiting
One Study Center