Can 89Zr-atezolizumab PET scan identify patients with metastatic invasive lobular breast cancer who will respond to chemotherapy-immune checkpoint inhibition?
Completed
- Conditions
- lobular breast cancer10006291
- Registration Number
- NL-OMON47947
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in tumor uptake between 89Zr-atezolizumab PET scan at baseline and after<br /><br>two carboplatin induction treatments, defined as decline or increase of<br /><br>standardized uptake value (SUV) of 30% or more, described as per lesion and per<br /><br>patient. </p><br>
- Secondary Outcome Measures
Name Time Method <p>* Relation of 89Zr-atezolizumab tumor uptake (at baseline, after carboplatin<br /><br>induction, and change between the two scans) per lesion and per patient with<br /><br>response to carboplatin-atezolizumab per lesion and per patient.<br /><br>* Relation of 89Zr-atezolizumab tumor uptake at baseline and after carboplatin<br /><br>induction, with tumor biopsy assessments (PD-L1 IHC, mRNA and other potential<br /><br>markers of interest in the setting of immune response such as macrophages).</p><br>