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    Clinical Trial Results:
    Phase II Study of Trastuzumab-Deruxtecan (T-DX; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases

    Summary
    EudraCT number
    		 2020-000981-41
    Trial protocol
    		 AT  
    Global end of trial date
    16 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Aug 2024
    First version publication date
    01 Aug 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TUXEDO-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04752059
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedUniWien
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Marika Rosner, Med. Univ. Wien, Klinik f. Innere Mdizin I, Onkologie, +43 14040044450, marika.rosner@meduniwien.ac.at
    Scientific contact
    Rupert Bartsch, Med. Univ. Wien, Klinik f. Innere Mdizin I, Onkologie, +43 14040044450, rupert.bartsch@meduniwien.ac.at
    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
    16 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Nov 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the ability of trastuzumab-deruxtecan to induce CNS responses in patients with HER2-positive breast cancer and newly diagnosed multiple brain metastases.
    Protection of trial subjects
    CT thorax/abdomen and MRI brain every 9 weeks
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2020
    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
    Austria: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    8
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 15 patients were enrolled at the University Hospital Vienna

    Pre-assignment
    Screening details
    		 15 patients were screened according to the inclusion and exclusion criteria

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trastuzumab-Deruxtecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5,4mg/kg intravenous every 3 weeks

    Number of subjects in period 1
    		Treatment arm
    Started
    15
    Completed
    15

    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
    		 15 15
    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)
    		 12 12
        From 65-84 years
    		 3 3
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 69 (30 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 1 1
    Subject analysis sets

    Subject analysis set title
    Objective response rate
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Simon’s two-stage phase II design

    Subject analysis sets values
    		 Objective response rate
    Number of subjects
    15
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    12
        From 65-84 years
    3
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    14
        Male
    1

    End points

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    End points reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 -

    Subject analysis set title
    Objective response rate
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Simon’s two-stage phase II design

    Primary: Overall trial

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    End point title
    		 Overall trial
    End point description
    End point type
    Primary
    End point timeframe
    From baseline until end of treatment
    End point values
    		 Treatment arm Objective response rate
    Number of subjects analysed
    15
    15
    Units: 22
        number (not applicable)
    15
    15
    Statistical analysis title
    		 Objective responses rate
    Comparison groups
    Treatment arm v Objective response rate
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 Simon's two stage design
    Confidence interval
    Notes
    [1] - descriptive statistics

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time of signing the informed consent through to the end of the designated follow-up period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Treatment related Adverse Events
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment related Adverse Events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 15 (53.33%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Ejection fraction decreased
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fatique
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Psychosis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    lung infection
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fever
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Treatment related Adverse Events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 15 (100.00%)
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 15 (53.33%)
         occurrences all number
    8
    Neutropenia
         subjects affected / exposed
    7 / 15 (46.67%)
         occurrences all number
    7
    Thrombocytopenia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    edema
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    12 / 15 (80.00%)
         occurrences all number
    12
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    5
    Diarrhoea
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Nausea
         subjects affected / exposed
    7 / 15 (46.67%)
         occurrences all number
    7
    Vomiting
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    5
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    7 / 15 (46.67%)
         occurrences all number
    7
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Infections and infestations
    shingles
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    thrush
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    4

    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.
    None reported
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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
    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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