PET Study of Breast Cancer Patients Using [68Ga]ABY-025

Breast Cancer Clinical Trial

Official title: An Exploratory Study to Evaluate [68Ga]ABY-025 for PET Imaging of HER2 Expression in Subjects With Metastatic Breast Cancer

Status Completed

Clinical Trial Summary

The study will evaluate [68Ga]ABY-025 for PET imaging of HER2 expression in subjects with HER2-positive or HER2-negative breast cancer.

Clinical Trial Description

Open-labeled, exploratory, single center study.

1. Group 1 (dose-finding) Six subjects with HER2-positive primary tumor status and four subjects with HER2-negative status. [68Ga]ABY-025 PET with low dose (100 μg) of ABY-025 peptide is performed, followed by a repeated PET within three weeks using high dose (500 μg) ABY-025 peptide (radioactivity maximum 500 MBq). A third [68Ga]ABY-025 PET will be performed in the HER2-positive subgroup only, when signs of progressive disease are found at routine clinical evaluation or else latest after 12 months regardless of disease status, then using the ABY-025 peptide dose previously determined to be preferable.

2. Group 2 Ten subjects with HER2-positive primary tumor status. [68Ga]ABY-025 PET is performed using the ABY-025 peptide dose determined to be preferable during the dose-finding part of the study, followed by a second [68Ga]ABY-025 PET investigation at signs of progressive disease or else latest after 9 months. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT01858116
• Study type: Interventional
• Source: Biomedical Radiation Sciences
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2013
• Completion date: June 2014