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    Clinical Trial Results:
    A randomised phase II trial of [18F]fluorothymidine and the standard tracer [18F]Fluorodeoxyglucose in the assessment of systemic therapy response in triple negative breast cancer and their utility compared to conventional MRI imaging response, early ADC change and biopsy derived biomarkers

    Summary
    EudraCT number
    		 2011-004220-34
    Trial protocol
    		 GB  
    Global end of trial date
    23 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Aug 2019
    First version publication date
    21 Aug 2019
    Other versions
    Summary report(s)
    		 RESULTS SUMMARY

    Trial information

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    Trial identification
    Sponsor protocol code
    TNPET01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Professor Andrew Tutt, King's College London, +44 02071884988, andrew.tutt@kcl.ac.uk
    Scientific contact
    Professor Andrew Tutt, King's College London, +44 02071884988, andrew.tutt@kcl.ac.uk
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Professor Andrew Tutt, Guy's and St Thomas' NHS Foundation Trust, +44 02071884988, andrew.tutt@kcl.ac.uk
    Scientific contact
    Professor Andrew Tutt, Guy's and St Thomas' NHS Foundation Trust, +44 02071884988, andrew.tutt@kcl.ac.uk
    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
    23 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part A: To confirm repeatability of Positron Emission Tomography (PET) scan SUV measurement before chemotherapy in triple negative breast cancer using [18F]FLT and [18F]FDG tracers Parts A and B: To evaluate PET imaging using [18F]FLT or [18F]FDG as a method for evaluating response to systemic therapy in primary triple negative breast cancer
    Protection of trial subjects
    Women of childbearing potential must have documented negative pregnancy test within the 2 weeks prior to day 1 chemotherapy and agree to use a medically acceptable birth control during the duration of their chemotherapy.
    Background therapy
    		 All Participants will receive 6-8 cyclophosphamide (x3-4) cycles standard sequential consisting of anthracycline/ and taxane (x-3-4) components chemotherapy prior to surgery.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2012
    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
    United Kingdom: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from a single centre in the UK between 2012 and 2017

    Pre-assignment
    Screening details
    		 A total of 25 patients with triple negative breast cancer will be enrolled:- n=10 Part A, n=15 Part B.

    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
    Are arms mutually exclusive
    Yes

    Arm title
    		 PART A - FDG
    Arm description
    		 FDG - 3 scans in total: 5 patients scanned using FDG PET component, 200 MBq of FDG: 4mSv CT component for attenuation correction and localisation of dynamic and 1st static PET scan: 1.5 mSv CT component for second static PET scan: 1.5 mSv CT component for third static PET scan: 1.5 mSv (CT parameters for all patients in this group 2FOV, 140 kVp, 32mAs, coll = 40 mm, pitch = 1.375) Total effective dose per session: 8.5 mSv Total effective dose for three sessions: 25.5 mSv
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MetaTrace FDG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    FDG tracer administration will be in accordance with the SmPC and patients will receive a maximum radioactivity dose of 200 MBq (-10%) [18F]-FDG by intravenous administration.

    Arm title
    		 PART A - FLT
    Arm description
    		 5 patients to be scanned using FLT. 3 scans in total PET component, 200 MBq FLT: 6.5 mSv (1) CT component for dynamic and static PET scan(2FOV, 140 kVp, 42mAs, coll = 40 mm, pitch = 1.375): 2 mSv Total effective dose per session: 8.5 mSv Total effective dose for three sessions: 26 mSv
    Arm type
    		 Experimental

    Investigational medicinal product name
    [18F]FLT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Aseptic technique is employed when preparing the drug for administration. The clinical dose of FLT will contain a maximum of 50 µg of [18F]-FLT, and radioactivity concentration. The volume will be adjusted to account for the radioactive concentration of the product at the time of administration. Participants will receive a maximum radioactivity dose of 200 MBq (-10%) [18F]FLT,, equating to a maximum chemical dose of less than 50 µg [18F]-FLT.

    Arm title
    		 PART B - FDG
    Arm description
    		 On confirmation of tracer repeatability in Part A analysis , a further 15 participants were expected to be recruited to Part B. All participants in Part B will be imaged using the tracer, FDG which met the repeatability criteria at the end of part A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MetaTrace FDG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    FDG tracer administration will be in accordance with the SmPC and patients will receive a maximum radioactivity dose of 200 MBq (-10%) [18F]-FDG by intravenous administration.

    Number of subjects in period 1
    		PART A - FDG PART A - FLT PART B - FDG
    Started
    5
    6
    11
    Completed
    5
    4
    10
    Not completed
    0
    2
    1
         Consent withdrawn by subject
    -
    1
    1
         FLT production failure - no IMP received
    -
    1
    -

    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
    		 22 22
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 22 22
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 22 22
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    PART A - FDG
    Reporting group description
    		 FDG - 3 scans in total: 5 patients scanned using FDG PET component, 200 MBq of FDG: 4mSv CT component for attenuation correction and localisation of dynamic and 1st static PET scan: 1.5 mSv CT component for second static PET scan: 1.5 mSv CT component for third static PET scan: 1.5 mSv (CT parameters for all patients in this group 2FOV, 140 kVp, 32mAs, coll = 40 mm, pitch = 1.375) Total effective dose per session: 8.5 mSv Total effective dose for three sessions: 25.5 mSv

    Reporting group title
    PART A - FLT
    Reporting group description
    		 5 patients to be scanned using FLT. 3 scans in total PET component, 200 MBq FLT: 6.5 mSv (1) CT component for dynamic and static PET scan(2FOV, 140 kVp, 42mAs, coll = 40 mm, pitch = 1.375): 2 mSv Total effective dose per session: 8.5 mSv Total effective dose for three sessions: 26 mSv

    Reporting group title
    PART B - FDG
    Reporting group description
    		 On confirmation of tracer repeatability in Part A analysis , a further 15 participants were expected to be recruited to Part B. All participants in Part B will be imaged using the tracer, FDG which met the repeatability criteria at the end of part A.

    Primary: PART A

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    End point title
    		 PART A [1]
    End point description
    To confirm PET scan SUV measurement repeatability using [18F]FDG and [18F]FLT tracers. Repeatability for both tracers will be within +/-15% (second scan at 3 days after first PET +/- 10% of baseline)
    End point type
    Primary
    End point timeframe
    End of study is defined as day of surgery. Patients will proceed to definitive surgery according to usual practice at 3 to 6 weeks after their final chemotherapy.
    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: Please see attached document
    End point values
    Number of subjects analysed
    Units: whole
    Attachments
    		 PART A RESULTS
    No statistical analyses for this end point

    Primary: PART B

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    End point title
    		 PART B [2]
    End point description
    To evaluate PET-CT imaging using [18F]FLT or [18F]FDG as methods for evaluating response to systemic therapy in primary triple negative breast cancer. Correlation of SUV response for tracer with conventional MRI RECIST response assessment after 3 cycles neoadjuvant chemotherapy
    End point type
    Primary
    End point timeframe
    End of study is defined as day of surgery. Patients will proceed to definitive surgery according to usual practice at 3 to 6 weeks after their final chemotherapy.
    Notes
    [2] - 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: Please see attached document
    End point values
    		 PART A - FDG PART A - FLT PART B - FDG
    Number of subjects analysed
    5
    4
    10
    Units: whole
    5
    4
    10
    No statistical analyses for this end point

    Secondary: Secondary Endpoints

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    End point title
    		 Secondary Endpoints
    End point description
    *The Time point in triple negative breast cancer where tumour SUV peaks *Correlate PET imaging response in breast and axillary lymph nodes with residual cancer burden (RCB) at definitive surgery *Correlate PET imaging response using each tracer with blood and biopsy derived biomarkers. These will include proliferation biomarkers, HER2:HER3 dimer (FRET Efficiency), apoptosis biomarkers, tumour genomic profiling analyses and blood derivatives for DNA, RNA and protein markers of the cancers biology *Non invasive assessment of Ki and k1 from this data set *Assess nodal response using PET imaging *Evaluate the ability of tracer to predict subsequent MRI response as a function of integrated ADC & size change. *Evaluate the ability of early early MRI size and ADC change to predict subsequent MRI response. *Confirm the safety of [18F]FLT in patients with breast cancer. *Correlate MRI imaging ADC change with blood & biopsy derived proliferation biomarkers & apoptosis biomarkers
    End point type
    Secondary
    End point timeframe
    End of trial
    End point values
    Number of subjects analysed
    Units: whole
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Until the end of trial (Day of surgery)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    PART A - FDG
    Reporting group description
    		 -

    Reporting group title
    PART A - [18F]FLT
    Reporting group description
    		 -

    Reporting group title
    PART B - FDG
    Reporting group description
    		 -

    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 non-serious adverse events were reported.
    Serious adverse events
    		 PART A - FDG PART A - [18F]FLT PART B - FDG
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 5 (20.00%)
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fever, headache, Lethargy
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Shortness of breath on minimal excursion
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iatrogenic pneumothorax
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PART A - FDG PART A - [18F]FLT PART B - FDG
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 May 2014
    Change from 30 to 25 participants sample size and change to reflect single tracer progressing to part B with increased power for this tracer

    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
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