Can 89Zr-atezolizumab PET scan identify patients with metastatic invasive lobular breast cancer who will respond to chemotherapy-immune checkpoint inhibition?

Can 89Zr-atezolizumab PET scan identify patients with metastatic invasive lobular breast cancer who will respond to chemotherapy-immune checkpoint inhibition? - ImaGelato

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001197-28-NL

Enrollment

Registered

2019-04-11

Start date

2019-07-31

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lobular metastatic breast cancer

Interventions

Product Name: [89Zr]-Atezolizumab Product Code: [89Zr]-Atezolizumab Pharmaceutical Form: Solution for injection INN or Proposed INN: MPDL3280A Other descriptive name: MPDL3280A Concentration unit: mg

Eligibility

Sex/Gender

All

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 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

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
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. • 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).	—

Measure

Time frame

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. • 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).

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Secondary

Measure	Time frame
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. • 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). ;Timepoint(s) of evaluation of this end point: Data analysis will be performed on an ongoing basis after every patient.	—

Measure

Time frame

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. • 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). ;Timepoint(s) of evaluation of this end point: Data analysis will be performed on an ongoing basis after every patient.

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Countries

Netherlands

Contacts

Public ContactDepartment of Medical Oncology

University Medical Center Groningen

c.p.schroder@umcg.nl+31503612821

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026