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    Clinical Trial Results:
    Early identification of patients who benefit from palbociclib in addition to letrozole

    Summary
    EudraCT number
    		 2015-004231-12
    Trial protocol
    		 NL  
    Global end of trial date
    28 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Feb 2023
    First version publication date
    08 Feb 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NL20151001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02806050
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Medical Center Groningen
    Sponsor organisation address
    Hanzeplein 1, Groningen, Netherlands, 9713 GZ
    Public contact
    CP Schröder, University Medical Center Groningen, +31 503616161, c.p.schroder@umcg.nl
    Scientific contact
    CP Schröder, University Medical Center Groningen, +31 503616161, 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
    28 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate in a feasibility study whether low uptake on FES-PET at baseline is related to non response to letrozole plus palbociclib treatment.
    Protection of trial subjects
    All patients will receive an effective treatment combination. In addition to the standard control visits to the clinic, three extra visits will be performed as part of the study: for screening, for the FES-PET scan and for the early FDG-PET. The FESPET scan will induce an extra radiation burden of 6.1 mSv and the early FDG-PET 5 mSv. In the future, this study may potentially contribute to improved selection of patients for this combination treatment. This is of relevance in view of optimal treatment for individual patients, avoiding unnecessary toxicity and financial burden.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Sep 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    20
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 31 patients were included in the study, 29 patients completed the study. 2 patients discontinued the study prematurely: - 1 patient had dural metastases therefore no response PET/CT scan was performed - 1 patient had elevated liver enzymes, therefore a response PET/CT was performed after 1 cycle (instead of after 2 cycles), progressive disease

    Pre-assignment
    Screening details
    		 See enclosed paper

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

    Arms
    Arm title
    		 Palbociclib and FES PET
    Arm description
    		 To evaluate whether low uptake on FES-PET at baseline is related to non-response to letrozole plus palbociclib treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    18F-FES
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    total 200 MBq

    Investigational medicinal product name
    Palbociclib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    per day 125 mg

    Number of subjects in period 1
    		Palbociclib and FES PET
    Started
    29
    Completed
    29

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 29 29
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 9 9
    Gender categorical
    Units: Subjects
        Female
    		 29 29
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Palbociclib and FES PET
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    study population

    Subject analysis sets values
    		 Palbociclib and FES PET
    Number of subjects
    29
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    20
        From 65-84 years
    9
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    29
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    Palbociclib and FES PET
    Reporting group description
    		 To evaluate whether low uptake on FES-PET at baseline is related to non-response to letrozole plus palbociclib treatment.

    Subject analysis set title
    Palbociclib and FES PET
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    study population

    Primary: The relation between low uptake on FES-PET to response per lesion

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    End point title
    		 The relation between low uptake on FES-PET to response per lesion [1]
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks after start of treatment
    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: See enclosed paper
    End point values
    		 Palbociclib and FES PET Palbociclib and FES PET
    Number of subjects analysed
    29
    29
    Units: SUV
    29
    29
    No statistical analyses for this end point

    Secondary: quantitative FES-uptake and correlation with progression free survival

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    End point title
    		 quantitative FES-uptake and correlation with progression free survival
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Palbociclib and FES PET Palbociclib and FES PET
    Number of subjects analysed
    29
    29
    Units: SUV
    29
    29
    No statistical analyses for this end point

    Secondary: analysis of circulating tumor DNA and correlation with FES-PET results and progression free survival

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    End point title
    		 analysis of circulating tumor DNA and correlation with FES-PET results and progression free survival
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Palbociclib and FES PET Palbociclib and FES PET
    Number of subjects analysed
    29
    29
    Units: SUV
    29
    29
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Frequency threshold for reporting non-serious adverse events: 3%
    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: See enclosed paper

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jun 2017
    1. Moving the FDG PET scan from 8 weeks to 2 weeks after the start of treatment. 2. Expand the number of patients from n=15 to n=30 for the implementation of point 1. Expanding the number of patients also enables further refinement of the FES-PET analysis: namely by adding a per-patient analysis with regard to response, in addition to the per-lesion analysis (the primary endpoint).
    14 Aug 2017
    update IMPD
    12 Feb 2018
    1. Expand inclusion of exclusively postmenopausal patients with also premenopausal patients, provided they are undergoing ovarian suppression with an LHRH analog 2. Textual adjustment in PIF and protocol that the combination treatment in The Netherlands is registered
    21 Aug 2018
    Diagnostic change in follow-up, in which the CT scan every 3 months for measurable disease according to RECIST criteria 1.1 is cancelled
    18 Sep 2018
    Update investigator's brochure palbociclib

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31891878
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    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
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