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

    Summary
    EudraCT number
    		 2019-001197-28
    Trial protocol
    		 NL  
    Global end of trial date
    01 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Oct 2022
    First version publication date
    12 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    201900180
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04222426
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Medical Centre Groningen
    Sponsor organisation address
    Hanzeplein 1, Groningen, Netherlands, 9713 GZ
    Public contact
    Department of Medical Oncology, University Medical Center Groningen, +31 503612821, c.p.schroder@umcg.nl
    Scientific contact
    Dr. C.P. Schröder, University Medical Center Groningen, +31 503612821, c.p.schroder@umcg.nl
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    01 May 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    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.
    Protection of trial subjects
    89Zr-atezolizumab injection is safe, only one related low-grade adverse event (pruritus) has been noted in 1 out of 22 patients who completed the full imaging series of up to four 89Zr-atezolizumab PET scans. Whenever possible, to minimize the burden, intervention and patients’visits are preferably planned on the same day. If not possible, for this study, patients will make max. 3 extra visits to the hospital. Since 89Zr-atezolizumab is a radioactive compound, it will cause radiation burden to the patient.89Zr-atezolizumab PET implements a radiation burden of about 18 mSv for 37 MBq 89Zr-atezolizumab and 1.5 mSv for each low dose CT scan. For patients participating in the study, this implies a maximum additional radiation burden of 2 x (18 + 1.5) = 39 mSv. This additional radiation burden (moderate risk) is justifiable in this category of adult patients with metastatic cancer.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Dec 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Due to the COVID pandemic inclusions were possibly slow. Due to the closure of the main study (GELATO) only 1 patient has been included in the study.

    Pre-assignment
    Screening details
    		 Due to the closure of the main study (GELATO) only 1 patient has been included in the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    not applicable.

    Arms
    Arm title
    		 89Zr-atezolizumab PET scan
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    [89Zr]-Atezolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Total of 37 MBq megabecquerel(s)

    Number of subjects in period 1
    		89Zr-atezolizumab PET scan
    Started
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    89Zr-atezolizumab PET scan
    Reporting group description
    		 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.

    Reporting group values
    		 89Zr-atezolizumab PET scan Total
    Number of subjects
    		 1 1
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    89Zr-atezolizumab PET scan
    Reporting group description
    		 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.

    Primary: 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

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    End point title
    		 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 [1]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    2 years
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: descriptive statistics
    End point values
    		 89Zr-atezolizumab PET scan
    Number of subjects analysed
    1
    Units: SUV
    1
    No statistical analyses for this end point

    Secondary: The relation between standardized uptake value (SUV) on 89Zr-atezolizumab PET scan, to response to carboplatin-atezolizumab

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    End point title
    		 The relation between standardized uptake value (SUV) on 89Zr-atezolizumab PET scan, to response to carboplatin-atezolizumab
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 89Zr-atezolizumab PET scan
    Number of subjects analysed
    1
    Units: SUV
    1
    No statistical analyses for this end point

    Secondary: The relation of 89Zr-atezolizumab tumor uptake at baseline and after two courses of carboplatin, with tumor biopsy assessments

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    End point title
    		 The relation of 89Zr-atezolizumab tumor uptake at baseline and after two courses of carboplatin, with tumor biopsy assessments
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 89Zr-atezolizumab PET scan
    Number of subjects analysed
    1
    Units: SUV
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    SAEs within 7 days of first knowledge for SAEs that result in death or are life threatening followed by a period of maximum of 8 days to complete initial report. All other SAEs within 15 days after sponsor has first knowledge.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Frequency threshold for reporting non-serious adverse events: 2%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: no adverse events observed

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The main study, and thus this trial, has a slow inclusion known by criteria such as: no bone biopsies possible, measurable disease required, which certainly in this exceptional subpopulation of lobular breast cancer patients proved to be very severe
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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