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    Clinical Trial Results:
    Randomised phase II study of paclitaxel alone versus paclitaxel plus sorafenib in second- or third-line treatment of patients with metastatic breast cancer

    Summary
    EudraCT number
    		 2009-018025-73
    Trial protocol
    		 DE  
    Global end of trial date
    19 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jun 2022
    First version publication date
    04 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GMIHO-008/2008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01320111
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH,
    Sponsor organisation address
    Almstadtstraße 7, Berlin, Germany, 10119
    Public contact
    CRO, iOMEDICO AG, 0049 761152420, info@iomedico.com
    Scientific contact
    CRO, iOMEDICO AG, 0049 761152420, info@iomedico.com
    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
    18 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This Study will assess the potential prolongation in progression free survival in patients with metastatic breast cancer in combination with standard chemotherapy paclitaxel compared with the paclitaxel monotherapy.
    Protection of trial subjects
    The conduct of this study was in compliance with the Good Clinical Practice Guidelines and under the guiding principles detailes in the Declaration of Helsinki. The study waas also carried out in keeping with applicable local law(s) and regulation(s).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Aug 2010
    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
    Germany: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was initiated in July 2010 and recruitment were stopped in November 2012 for an interim analysis. Based on the results, recruitment was terminated. A total of 60 (Arm A: 30, Arm B: 30) patients were enrolled at 21 sites in Germany.

    Pre-assignment
    Screening details
    		 The patients were randomised between the study groups and stratified according to line of treatment (2nd or 3rd) and pretreatment with bevacizumab.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A (Standard treatment)
    Arm description
    		 Paclitaxel monotherapy with 80 mg/m² as one-hour i.v. infusion on day 1, 8, 15 every 28 days (one cycle). Dosing levels for dose reduction: 61.6 mg/m² and 45.6 mg/m².
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    80 mg/m² as one-hour i.v. infusion on day 1, 8, 15 every 28 days (one cycle)

    Arm title
    		 Arm B (Test treatment)
    Arm description
    		 Combination therapy with paclitaxel 80 mg/m2 as one-hour i.v. infusion on day 1, 8, 15 and sorafenib 400 mg orally twice daily (bid), i.e. 2x200 mg tablets in the morning and 2x200 mg tablets in the evening, taken continuously throughout 28-day cycles. Sorafenib levels for dose escalation and dose reductions: 200 mg in the morning, 200 mg in the evening (200 mg bid) and 200 mg in the morning, 400 mg in the evening. Paclitaxel levels for dose reductions: 61.6 mg/m² and 45.6 mg/m².
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    paclitaxel 80 mg/m2 as one-hour i.v. infusion on day 1, 8, 15

    Investigational medicinal product name
    Sorafenib
    Investigational medicinal product code
    Other name
    Nexavar®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg orally twice daily (bid) taken continuously throughout 28-day cycles

    Number of subjects in period 1
    		Arm A (Standard treatment) Arm B (Test treatment)
    Started
    30
    30
    Completed
    28
    28
    Not completed
    2
    2
         Consent withdrawn by subject
    -
    1
         non-eligible
    1
    1
         non-evaluable
    1
    -

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Arm A (Standard treatment)
    Reporting group description
    		 Paclitaxel monotherapy with 80 mg/m² as one-hour i.v. infusion on day 1, 8, 15 every 28 days (one cycle). Dosing levels for dose reduction: 61.6 mg/m² and 45.6 mg/m².

    Reporting group title
    Arm B (Test treatment)
    Reporting group description
    		 Combination therapy with paclitaxel 80 mg/m2 as one-hour i.v. infusion on day 1, 8, 15 and sorafenib 400 mg orally twice daily (bid), i.e. 2x200 mg tablets in the morning and 2x200 mg tablets in the evening, taken continuously throughout 28-day cycles. Sorafenib levels for dose escalation and dose reductions: 200 mg in the morning, 200 mg in the evening (200 mg bid) and 200 mg in the morning, 400 mg in the evening. Paclitaxel levels for dose reductions: 61.6 mg/m² and 45.6 mg/m².

    Primary: Progression-free survival (PFS)

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    End point title
    		 Progression-free survival (PFS)
    End point description
    End point type
    Primary
    End point timeframe
    from randomisation to disease progression or death
    End point values
    		 Arm A (Standard treatment) Arm B (Test treatment)
    Number of subjects analysed
    23
    27
    Units: month
        median (confidence interval 95%)
    6.6 (5.1 to 9.0)
    5.6 (3.8 to 6.5)
    Statistical analysis title
    		 Primary efficacy
    Comparison groups
    Arm A (Standard treatment) v Arm B (Test treatment)
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0409
    Method
    		 Logrank
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    from randomisation until disease progression or death
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Apart from 1 patient in Arm A, all patients experienced at least 1 adverse event. The most common adverse events of any toxicity grade in Arm A were peripheral neuropathy (55% of patients), fatigue (45%), diarrhoea (41%) and alopecia (41%). In Arm B, the most common adverse events were diarrhoea (57%), fatigue (50%), mucositis oral (39%) and peripheral neuropathy (36%).

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2010
    Study protocol (3.0, 02 Nov 2010): Clarification of wording of inclusion/exclusion criteria; formal corrections/changes; subsequent submission of study sites;
    05 Apr 2013
    Study protocol (4.0, 15 Feb 2013): Formal implementation of temporary halt of recruitment after recruitment of the 60. patient (measure not caused by safety issue); implementation of a prospective efficacy interim analysis (including enhancement of required total patient number (128 to 148); prolongation of recruitment phase); formal corrections/changes

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    17 Dec 2012
    Temporary halt of recruitment after recruitment of the 60. patient (measure not caused by safety issue); announcement of implementation of a prospective efficacy interim analysis and related protocol amendment.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Premature study termination due to futility (decision based on results of prospective efficacy interim analysis July/2013); recruitment was not resumed; study continued regular follow-up phase as per protocol.
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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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