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

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