Clinical Trial · NCT01420146

Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients

Overview

Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab.

Sponsor

Jules Bordet Institute

Phase

Phase 1

Contacts

Patrick Flamen, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

Drug / Compound

Isotope(s):

Target(s):

Ligand Class: Antibodies

Chelator: DFO

Eligibility

Brain metastases are allowed provided they are controlled and they are not the sole site of metastatic disease.
Agreement from the patient to participate in this imaging study and if indicated agreement to biopsy one or two accessible lesions.
Patient planned to have metastatic site biopsy for HER2 status control.
Patients with FDG-PET positive metastatic lesions.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1
For women of childbearing potential a pregnancy test will be done and an agreement to use a highly-effective non hormonal form of contraception.
All patients selected for this imaging study are patients scheduled to start trastuzumab-based therapy for advanced HER2 positive breast cancer (This includes trastuzumab alone, trastuzumab + chemotherapy, trastuzumab + endocrine therapy).
Histologically confirmed HER 2 positive (defined as FISH amplification ratio more than 2.2) invasive carcinoma of the breast (primary tumor at diagnosis) with locally recurrent or metastatic disease.

Patients who received lapatinib within the 7 days prior to HER immunoPET/CT.
Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
Known severe hypersensitivity to trastuzumab
Patients with bone only metastases are not eligible
Current known infection with HIV, HBV, or HCV
Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
Psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or lactating women