All patients will undergo two 89Zr-atezolizumab PET scans, one at baseline and one after two doses carboplatin induction treatment. The 89Zr-atezolizumab PET scan will be performed 4 days after tracer injection. Procedures within the ImaGelato study will be completed after the two 89Zr-atezolizumab PET scans, but patients will continue treatment with carboplatin combined with atezolizumab in the GELATO trial.

Lobular Metastatic Breast Cancer

Patients receive a total amount of 10 mg unlabeled atezolizumab, this will be added to the tracer to prevent rapid clearance during imaging. A labeled dose of 37 Megabequerell (MBq) 89Zr-atezolizumab (±10%; 1 Millicurie) will then be administered. The tracer will be administered intravenously (i.v.). All patients will undergo two 89Zr-atezolizumab PET scans, one at baseline and one after two doses carboplatin induction treatment. After each tracer injection, 89Zr-atezolizumab PET scans will be performed on day 4 (96 ± 6h after tracer administration).

89Zr-atezolizumab PET scans

University Medical Center Groningen

89Zr-atezolizumab PET Scan and Lobular Breast Cancer

Can 89Zr-atezolizumab PET Scan Identify Patients With Metastatic Invasive Lobular Breast Cancer Who Will Respond to Chemotherapy-immune Checkpoint Inhibition?

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. For the two different time points we will calculate the SUV for all lesions and patients. Relative decrease or increase in SUV units between different time points will be calculated for all lesions and patients, and recorded as percentage of SUV decrease or increase.

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. For the 89Zr-atezolizumab PET scans, uptake will be quantified with SUV units for both time points.

Relation of 89Zr-atezolizumab tumor uptake at baseline and after carboplatin induction, with tumor biopsy assessments (for example PD-L1 immunohistochemistry (IHC)). We will investigate whether PD-L1 expression is associated with 89Zr-atezolizumab uptake. The relationship between tumor PD-L1 expression (measured in pre-treatment biopsy and induction treatment biopsy), and 89Zr-atezolizumab tumor uptake will be described.

C.P. Schroder

principal investigator

Locally Advanced or Metastatic Solid Tumors Irrespective of PD-L1 Expression

89Zr-MPDL3280A tracer injection and 89Zr-MPDL-3280A-PET scans

89Zr-MPDL-3280A-PET scans

MPDL3280A-imaging-IST-UMCG

ImmunoPET Imaging With 89Zr-MPDL3280A in Patients With Locally Advanced or Metastatic Solid Tumors Prior to and During MPDL3280A Treatment

Prof.dr. E.G.E. de Vries

Principal Investigator

All patients receive 18F-FES (~200MBq) injection followed by a FES-PET. On the same day or the day after 18F-FES injection 89Zr-trastuzumab (~37 MBq) will be injected. The HER2-PET will be performed 4 days after tracerinjection.

Metastatic Breast Cancer

On the day of FES-injection&scan or the day after FES-injection, 89Zr-trastuzumab (~37 MBq) will be injected. The HER2-PET will be performed 4 days after tracerinjection.

Molecular imaging

All patients receive 18F-FES (~200MBq) injection followed by a FES-PET.

VU University Medical Center

University Medical Center

University Medical Center St. Radboud

IMaging PAtients for Cancer Drug selecTion - Metastatic Breast Cancer

Towards Patient Tailored Cancer Treatment Supported by Molecular Imaging IMPACT: IMaging PAtients for Cancer Drug selecTion - Metastatic Breast Cancer

The primary objective is to evaluate the clinical utility of experimental PET scans, in the setting of MBC at first presentation. These scans include Fluor-18-16 alpha-fluoroestradiol(18F-FES)-PET and Zirconium-89(89Zr)-trastuzumab-PET scans at baseline, and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG)-PET for early response measurement. Clinical utility in this setting might be defined as improved personalized medicine, when the PET scans show improved predictive value for therapy response in comparison or in addition to currently available clinical information including a biopsy. But also when the PET scans would have the same predictive value for therapy response compared to a biopsy, they would have clinical utility because they are less invasive and more patient friendly. The inherent focus (the primary endpoint) of this study is therefore therapy response. Therapy response will be related to the novel PET scans, both per patient and per metastasis analysis.

To relate experimental PET scans (baseline 18F-FES-PET and 89Zr-trastuzumab-PET; 2 week 18F-FDG-PET scan) to (progression free) survival.

To relate DNA sequencing and RNA expression analysis of the baseline biopsy and venous blood samples (only DNA sequencing; baseline) to all other molecular, imaging (standard and experimental), and clinical follow-up data (treatment response and survival).

To relate miRNA analysis of the baseline biopsy and a venous blood sample at baseline to all other molecular, imaging and clinical follow-up data.

To relate peptide profiling of new baseline biopsy and venous blood samples (baseline and day of standard response assessment) to all other molecular, imaging and clinical follow-up data.

To assess molecular changes (including pathological examination) of primary biopsy, new baseline biopsy and (optional) biopsy taken during treatment and relate to all molecular, imaging and clinical follow up data.

To relate CTC count and ER/HER2 status of CTCs at baseline to all molecular, imaging and clinical follow-up data.

To relate circulating tumor DNA analysis (baseline, day of early 18F-FDG-PET imaging and day of standard response assessment) to all other molecular, imaging and clinical follow-up data.

To assess cost-effectiveness of experimental PET scans.

To assess impact of baseline biopsy procedure and baseline molecular imaging, as well as quality of Life (QoL) before and during therapy.

MD, PhD

University Medical Center Nijmegen

After an imaging phase, the patient will receive T-DM1 iv every 3 weeks until progression or toxicity

HER-2 Positive Breast Cancer

T-DM1

Injection of 89Zr-trastuzumab for HER2 imaging

89Zr-trastuzumab

Universitair Ziekenhuis Antwerpen (UZA)

Institut Jules Bordet

Vrije Universiteit Amsterdam (VUMC)

University Medical Center Groningen (UMCG)

Radboud University Medical Centre Nijmegen (UMCN)

HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1

Phase II Prospective Imaging Study Evaluating the Utility of Pre-treatment zr89 Labelled Trastuzumab PET/CT and an Early FDG-PET/CT Response to Identify Patients With Advanced HER2+ BC Unlikely to Benefit From a Novel antiHER2 Therapy: TDM1

The primary objective is to show that pre-treatment 89Zr-trastuzumab PET/CT is able to select lesions not responding morphologically from treatment with T-DM1 (applying RECIST 1.0 criteria).

The first secondary objective is to show that early FDG PET/CT (performed after one cycle of T-DM1 just before the second cycle) is able to select lesions not responding from treatment with T-DM1 according to metabolic and morphological response criteria post 3 cycles of T-DM1.

The second secondary objective is to show that 89Zr-trastuzumab PET/CT is able to select lesions not responding from treatment with T-DM1 according to metabolic response criteria post 3 cycles of T-DM1.

The third secondary objective is to show that a lesion with no/faint uptake on 89Zr-trastuzumab PET/CT and not responding metabolically on the early FDG-PET/CT will not respond according to metabolic and morphological criteria after 3 cycles of T-DM1.

Jules Bordet Institute

Roche Pharma AG

Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm

Zr89-trastuzumab PET/CT

Sex: Female, Male

Region of Enrollment

A visual 'patient-based' classification capturing the whole disease burden was developed by using a side-by-side display, comparing baseline FDG-PET/CT(showing all FDG-positive mets independent of their HER2-imaging status) & day4 HER2-PET/CT. Pts were grouped into 4 HER2-PET/CT patterns according to the proportion of FDG avid tumour load showing relevant 89Zr-T uptake. Pattern A: entire tumor load showed pertinent tracer uptake; B: dominant part of tumour load showed tracer uptake; C: minor part of tumor load showed tracer uptake; D: entire tumor load lacked tracer uptake. Patterns A+B='HER2-positive' & C+D='HER2-negative'. In the 20 pts: 4 pts were classified "A", 5"B", 1"C" & 10"D". This classification indicates substantial heterogeneity of 89Zr-T uptake within this so called 'HER2-positive' pt population. After dichotomization, 11(55%) pts were considered as HER2-PET/CT negative. Furthermore, HER2-PET/CT revealed intrapatient heterogeneity of tumour uptake(pts classified B or C).

Test the Diagnostic Accuracy of the HER2 Imaging Using the Labelled Monoclonal Antibody Trastuzumab by Correlating the HER2 PET/CT Imaging With the FDG-PET/CT and Molecular Characterization of Tumor Samples With Discordant Image Findings

Time activity curve of normal organ and tumor lesions: pharmacokinetic

Time Activity Curve

evaluate the concentration of circulating HER2 extracellular domain in the blood and study his possible role as on imaging quality

HER2 Extracellular Domain

Overall Study

Dr Géraldine Gebhart

Zr89-trastuzumab PET/CT single arm
Zr89-trastuzumab: trastuzumab labelled with zirconium 89 for PET/CT

Breast Neoplasms

Secondary

HER2 Positive Carcinoma of Breast

trastuzumab labelled with zirconium 89 for PET/CT

Zr89-trastuzumab

Jules Bordet Institut

Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients

Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients : Correlation With FDG-PET/CT and Anatomopathological Results

zirconium/cancer mamar

89Zr-atezolizumab PET Scan and Lobular Breast Cancer

MPDL3280A-imaging-IST-UMCG

IMaging PAtients for Cancer Drug selecTion - Metastatic Breast Cancer

HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1

Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients

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