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    Clinical Trial Results:
    A phase ll trial of combination chemotherapy with intravenous oxaliplatin combined with tablet capecitabin in patients with recidivant breastcancer

    Summary
    EudraCT number
    		 2012-005329-56
    Trial protocol
    		 DK  
    Global end of trial date
    01 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2019
    First version publication date
    27 Nov 2019
    Other versions
    Summary report(s)
    		 CAPOX_article

    Trial information

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    Trial identification
    Sponsor protocol code
    MA1229
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev University Hospital
    Sponsor organisation address
    Herlev Ringvej 75, Herlev, Denmark, 2730
    Public contact
    Dept of oncology, Dept of oncology, Herlev Hospital, 0045 38682344, Dorte.nielsen.01@regionh.dk
    Scientific contact
    Dept of oncology, Dept of Oncology, Herlev Hospital, 0045 38682344, Dorte.nielsen.01@regionh.dk
    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 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Clinical Benefit rate (Number of patients with complete or partial response or stable disease >= 6 months (Recist 1.1)
    Protection of trial subjects
    The study was approved by the Regional Scientific Ethics Committee (VEK no. H-4-2013-034), the Danish Medicine Agency (EudraCT no 2012-005329-56) and signed informed consent was obtained from all patients included. The study was conducted in accordance with the principles of good clinical practice and the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2013
    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
    Denmark: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    12
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients recruited at single site at Herlev Hospital, Department of Oncology, Denmark, Recruitment was open from Dec 2013 to Aug 2015

    Pre-assignment
    Screening details
    		 Eligible women were required to have locally advanced or metastatic, histologically or cytologically confirmed breast cancer as well as a HER-2 negative tumor.Previous adjuvant treatment with taxane and epirubicin or with taxane and cyclophosphamide followed by first line treatment with epirubicin was required.

    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
    		 CapOx
    Arm description
    		 Capecitabine and Oxaliplatin (CapOx)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1300 mg/m2 daily divided into two doses

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Oxaliplatin was administered intravenously at 85 mg/m2 as a 30-minute infusion on day 1 of each 2-weeks cycle

    Number of subjects in period 1
    		CapOx
    Started
    18
    Completed
    15
    Not completed
    3
         Consent withdrawn by subject
    2
         Adverse event, non-fatal
    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
    		 18 18
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 57.5 (42 to 74) -
    Gender categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    CapOx
    Reporting group description
    		 Capecitabine and Oxaliplatin (CapOx)

    Primary: Clinical Benefit Rate

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    End point title
    		 Clinical Benefit Rate [1]
    End point description
    Patients with SD >= 6 months or partial response or complete response
    End point type
    Primary
    End point timeframe
    Disease status assessed by CT scan every 8th week from treatment start to progression of disease
    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: Simon two-stage design -stage 1 analyse: The Clinical Benefit Rate (CBR; complete response, partial remission and stable disease ≥ 6 months) limit of > 50% was not met and the study was closed.
    End point values
    		 CapOx
    Number of subjects analysed
    18
    Units: number of patients
    9
    No statistical analyses for this end point

    Secondary: Best Overall Response

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    End point title
    		 Best Overall Response
    End point description
    End point type
    Secondary
    End point timeframe
    Disease status assessed by CT scan every 8th week from treatment start to progression of disease
    End point values
    		 CapOx
    Number of subjects analysed
    18
    Units: number of patients
        CR
    1
        PR
    4
        SD
    7
        PD
    6
    No statistical analyses for this end point

    Secondary: Progression free Survival

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    End point title
    		 Progression free Survival
    End point description
    End point type
    Secondary
    End point timeframe
    PFS was calculated as the period from the first treatment to disease progression or death of any cause.
    End point values
    		 CapOx
    Number of subjects analysed
    18
    Units: months
        median (confidence interval 95%)
    5.2 (4.8 to 5.6)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    End point type
    Secondary
    End point timeframe
    OS was calculated as the time from the first treatment to death from any cause or until May 1st 2017
    End point values
    		 CapOx
    Number of subjects analysed
    18
    Units: months
        median (confidence interval 95%)
    12.9 (4.1 to 21.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of treatment to 28 days after last treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    CapOx
    Reporting group description
    		 Capecitabine and Oxaliplatin (CapOx)

    Serious adverse events
    		 CapOx
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 18 (27.78%)
         number of deaths (all causes)
    17
         number of deaths resulting from adverse events
    1
    Vascular disorders
    Pulmonary embolism
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    vena cava syndrome
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Musculoskeletal and connective tissue disorders
    Paresis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CapOx
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 18 (100.00%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 18 (33.33%)
         occurrences all number
    6
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 18 (27.78%)
         occurrences all number
    5
    Platelet count decreased
         subjects affected / exposed
    9 / 18 (50.00%)
         occurrences all number
    9
    Neutrophil count decreased
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Cardiac disorders
    Chest pain
         subjects affected / exposed
    4 / 18 (22.22%)
         occurrences all number
    4
    Nervous system disorders
    Dysaesthesia
         subjects affected / exposed
    17 / 18 (94.44%)
         occurrences all number
    18
    Peripheral sensory neuropathy
         subjects affected / exposed
    15 / 18 (83.33%)
         occurrences all number
    16
    Headache
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    12 / 18 (66.67%)
         occurrences all number
    14
    flu like symptoms
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Infusion related reaction
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 18 (27.78%)
         occurrences all number
    6
    Nausea
         subjects affected / exposed
    14 / 18 (77.78%)
         occurrences all number
    16
    Stomatitis
         subjects affected / exposed
    12 / 18 (66.67%)
         occurrences all number
    13
    Vomiting
         subjects affected / exposed
    7 / 18 (38.89%)
         occurrences all number
    8
    Constipation
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Gastritis
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    10 / 18 (55.56%)
         occurrences all number
    13
    Infections and infestations
    Paronychia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Infection
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2

    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.
    NA, Trial was stopped after analyses of first stage in Simon´s two stage design.
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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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