Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients
Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled
 trastuzumab.
This is the first belgian feasibility study of HER2 imaging using a labelled monoclonal
 antibody, namely trastuzumab labelled with zirconium 89.

 The aims of this study are:

 I/ Evaluate the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab
 (based on the Groningen experience), through the analysis of the correlation between the
 FDG-PET/CT and the HER2 immunoPET.

 II/ PET quantification of HER2 receptor by using the images and the blood pharmacokinetic of
 the tracer.

 III/ In the subset of patients for whom biopsies of metastatic sites have not been carried
 out previously and are of an easy access, tissue will be acquired as part of the validation
 of the HER2 immunoPET and as an attempt to better understand the molecular heterogeneity of
 HER2 positive breast cancer at the time of relapse.

 IV/Evaluate the concentration of circulating HER2 extracellular domain in the blood and study
 his possible role as on imaging quality
Inclusion criteria:

 1. 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).

 2. 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.

 3. Patients with FDG-PET positive metastatic lesions.

 4. Brain metastases are allowed provided they are controlled and they are not the sole
 site of metastatic disease.

 5. Patient planned to have metastatic site biopsy for HER2 status control.

 6. Age ≥ 18 years

 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1

 8. For women of childbearing potential a pregnancy test will be done and an agreement to
 use a highly-effective non hormonal form of contraception.

 9. Agreement from the patient to participate in this imaging study and if indicated
 agreement to biopsy one or two accessible lesions.

 10. Signed written informed consent (approved by the Ethics Committee) obtained prior to
 any study procedure

 Exclusion criteria:

 1. Current severe, uncontrolled systemic disease (e.g., clinically significant
 cardiovascular, pulmonary, or metabolic disease)

 2. Pregnant or lactating women

 3. Current known infection with HIV, HBV, or HCV

 4. Known severe hypersensitivity to trastuzumab

 5. Assessed by the investigator to be unable or unwilling to comply with the requirements
 of the protocol

 6. Patients with bone only metastases are not eligible

 7. Psychiatric illness/social situations that would limit compliance with study
 requirements

 8. Patients who received lapatinib within the 7 days prior to HER immunoPET/CT.