Primary 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.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
* 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).
Background summary
Recent studies show that an 89Zr-atezolizumab PET scan can predict the
sensitivity to an immune therapy treatment with atezolimab. But if the scan can
also show possible changes in chemotherapy sensitivity, is not known. The use
of the 89Zr-atezolizumab is experimental and not-approved for standard tumor
imaging. Therefore we would like to perform this special PET scan in the
ImaGelato study, in patients participating in the GELATO study in the UMCG,
prior and during chemotherapy.
Study objective
Primary 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.
Study design
This exploratory single center feasibility ImaGelato study is conducted as an
imaging side study to the Dutch GELATO trial (ClinicalTrials.gov NCT03147040;
METc 2018/113).
Intervention
All patients will undergo two 89Zr-atezolizumab PET scans, one at baseline and
one after two doses carboplatin induction treatment. The PET scan will be
performed 4 days after tracer injection.
Study burden and risks
For the ImaGelato study, 3 extra visits to the clinic are required in addition
to those for the GELATO trial: (1) for screening plus injection (2) for the
first PET scan, (3) for the second tracer injection OR second PET scan. The
other study visits will be performed simultaneously with visits for the GELATO
trial. The PET scan will induce an extra radiation burden of about 18 mSv, and
1.5 mSv per low-dose CT scan (in total 39 mSv for 2 PET scans). No individual
benefit is expected from study participation. In the future, this study may
potentially contribute to improved insight in the effect of chemotherapy on
response to immune checkpoint inhibitors in cancer types that are relatively
unresponsive to immunotherapy such as (lobular) breast cancer. Ultimately this
study may contribute to optimal patient selection and treatment with
immunotherapy. This is of relevance in view of optimal treatment for individual
patients, avoiding unnecessary toxicity and financial burden.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR201900180-NL |
| CCMO | NL69601.042.19 |
| Other | volgt |