lobular breast cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. A patient must meet the inclusion criteria of the GELATO trial (see in attachment the protocol) 2. Able to give written informed consent and to comply with the ImaGelato protocol
Exclusion criteria
Exclusion criteria: 1. Contra-indication for 89Zr-atezolizumab PET scan 2. Any approved anti-cancer therapy, including chemotherapy or hormonal therapy within *14 days prior to the first 89Zr-atezolizumab injection. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the first 89Zr-atezolizumab injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in tumor uptake between 89Zr-atezolizumab PET scan at baseline and after two carboplatin induction treatments, defined as decline or increase of standardized uptake value (SUV) of 30% or more, described as per lesion and per patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Relation of 89Zr-atezolizumab tumor uptake (at baseline, after carboplatin induction, and change between the two scans) per lesion and per patient with response to carboplatin-atezolizumab per lesion and per patient. * Relation of 89Zr-atezolizumab tumor uptake at baseline and after carboplatin induction, with tumor biopsy assessments (PD-L1 IHC, mRNA and other potential markers of interest in the setting of immune response such as macrophages). | — |
Countries
Netherlands