HER2-expression PET Imaging in Metastatic Breast Cancer
Data Collection
Collected from today forward - ProspectiveBreast Diseases+3
+ Breast Neoplasms
+ Neoplasms
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.70 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.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