NCT01832051

Clinical Value of 89Zr-trastuzumab PET

HER2-PET as a Diagnostic Tool in Breast Cancer Patients With a Clinical Dilemma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor lesions in breast cancer patients is essential for diagnostic and therapeutic management of metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional information, have so far not been able to replace the biopsy. To solve this problem, non-invasive whole body visualization and quantification of HER2 expression by means of the HER2-PET may be a valuable tool. In this prospective multicenter imaging study, eligible patients will receive one HER2-PET and CTC analysis in addition to standard work up for metastatic disease. Subsequent administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three questionnaires, one before HER2-PET and two after HER2-PET.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	89Zr-trastuzumab injection

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-06-01
• Completion: 2015-10-01
• First posted: 2013-04-15
• Last updated: 2015-11-05

Locations

1 site across 1 country: Netherlands