Molecular PD-L1 PET/CT Imaging With 89Zr-atezolizumab to Monitor Immune Responses in Metastatic Triple Negative Breast Cancer
The overarching purpose of this study is to improve precision medicine through more refined therapy selection for breast cancer patients who are candidates for ICI therapy (monoclonal antibodies targeting the programmed death ligand 1 (PD-L1) or programmed cell death protein 1 (PD-1)). The reference standard biomarker for ICI therapy selection is PD-L1 protein expression measured by immunohistochemistry (IHC). Several disadvantages exist with this method, the most important ones being inter- and intralesional as well as spatial heterogeneity in PD-L1 expression, as well as the need for invasive procedures to obtain material for analysis. The study hypothesis is that Positron Emission Tomography combined with Computed Tomography (PET/CT) imaging with a contemporary radiotracer (89Zr-atezolizumab), visualizing PD-L1 expression in the whole body, could be a better predictive biomarker to select which patients benefit from ICI. The use of PET/CT imaging with new radiotracers enables a non-invasive assessment of the presence of the target of treatment in the whole body and provides the possibility to combine functional information with anatomical details.
• Patients with metastatic triple negative breast cancer (mTNBC), defined by pathological criteria: oestrogen receptor expression \<10%, progesterone receptor expression \<10%, HER2 negative, on the primary tumour or a metastatic biopsy
• Measurable disease according to RECIST v1.1
• At least one metastatic lesion accessible for biopsy
• Deemed by treating physician as fit for systemic therapy according to study protocol
• ECOG performance score 0/1
• Age ≥ 18 years old
• Adequate blood tests for bone marrow, renal and hepatic functions
• Able and willing to provide written informed consent