Can 89Zr-atezolizumab PET scan identify patients with metastatic invasive lobular breast cancer who will respond to chemotherapy-immune checkpoint inhibition?
- Conditions
- obular metastatic breast cancerTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2019-001197-28-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 10
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the feasibility to detect a change in tumor PD-L1 expression on a 89Zr-atezolizumab PET scan, before and after two carboplatin induction treatments.;Primary end point(s): • 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 (SUVpeak) of 30% or more, described as per lesion and per patient.;Timepoint(s) of evaluation of this end point: Data analysis will be performed on an ongoing basis after every patient.;Secondary Objective: • To assess the relation of 89Zr-atezolizumab tumor uptake (change) with response to carboplatin-atezolizumab. <br>• To determine the relation of 89Zr-atezolizumab tumor uptake at baseline and after two courses of carboplatin, with tumor biopsy assessments (PD-L1 IHC, mRNA and other potential markers of interest in the setting of immune response such as macrophages).<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • 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. <br>• 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).<br>;Timepoint(s) of evaluation of this end point: Data analysis will be performed on an ongoing basis after every patient.