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    Clinical Trial Results:
    A randomised, double blind, placebo controlled, phase II study of fulvestrant with or without the addition of vandetanib as treatment for patients with metastatic breast cancer resistant to aromatase inhibitor therapy

    Summary
    EudraCT number
    		 2014-001208-23
    Trial protocol
    		 GB  
    Global end of trial date
    30 Jun 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Apr 2026
    First version publication date
    04 Apr 2026
    Other versions
    Summary report(s)
    		 FURVA BJC Reports

    Trial information

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    Trial identification
    Sponsor protocol code
    2014/VCC/0013
    Additional study identifiers
    ISRCTN number
    		 ISRCTN13663157
    US NCT number
    		 NCT02530411
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Velindre NHS Trust
    Sponsor organisation address
    Unit 2 Charnwood Court, Cardiff, United Kingdom, CF15 7QZ
    Public contact
    Angela Casbard, Centre for Trials Research, Cardiff University, 44 29 2068 7500, FURVA@cardiff.ac.uk
    Scientific contact
    Angela Casbard, Centre for Trials Research, Cardiff University, 44 29 2068 7500, FURVA@cardiff.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
    18 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish whether the combination of vandetanib and fulvestrant will improve clinical outcome in patients with endocrine resistant advanced breast cancer (RECIST v1.1).
    Protection of trial subjects
    The IDMC reviewed the data at two safety reviews after 20 and 40 participants received at least 1 cycle of treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2015
    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
    United Kingdom: 165
    Worldwide total number of subjects
    165
    EEA total number of subjects
    0
    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)
    81
    From 65 to 84 years
    82
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Before any trial related procedures are undertaken, the patient’s written informed consent must be obtained. The patient should be given a minimum of 24 hours after initial invitation to participate before being asked to sign the consent form. Screening logs should be completed for every patient considered for the trial.

    Period 1
    Period 1 title
    Main (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fulverstrant plus vandetanib
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vandetanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received oral vandetanib/placebo tablets once a day by mouth for the duration of the trial, until IMP treatment is discontinued. The starting dose was 300 or 200 mg dependent on renal impairment status.

    Arm title
    		 Fulvestrant plus placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    vandetanib placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will receive oral vandetanib/placebo tablets once a day by mouth for the duration of the trial, until IMP treatment is discontinued.

    Number of subjects in period 1
    		Fulverstrant plus vandetanib Fulvestrant plus placebo
    Started
    80
    85
    Completed
    80
    85

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fulverstrant plus vandetanib
    Reporting group description
    		 -

    Reporting group title
    Fulvestrant plus placebo
    Reporting group description
    		 -

    Reporting group values
    		 Fulverstrant plus vandetanib Fulvestrant plus placebo Total
    Number of subjects
    		 80 85 165
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 40 41 81
        From 65-84 years
    		 38 44 82
        85 years and over
    		 2 0 2
    Gender categorical
    Units: Subjects
        Female
    		 80 85 165
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Fulverstrant plus vandetanib
    Reporting group description
    		 -

    Reporting group title
    Fulvestrant plus placebo
    Reporting group description
    		 -

    Primary: Progression Free Survival

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    End point title
    		 Progression Free Survival [1]
    End point description
    Progression-free survival (PFS - time to event) based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
    End point type
    Primary
    End point timeframe
    Time to event
    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: Progression-free survival (PFS - time to event) based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
    End point values
    		 Fulverstrant plus vandetanib Fulvestrant plus placebo
    Number of subjects analysed
    80
    85
    Units: Number
    median (confidence interval 95%)
        PFS mean
    5.5 (3.6 to 8.9)
    5.5 (3.5 to 8.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    At baseline, during treatment, at the end of treatment, at the end of study
    Adverse event reporting additional description
    Full report of AEs and SAEs is in the publication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: Full list of AEs and SAEs can be found in the paper.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Dec 2016
    Revision of Protocol V2.0 09/12/2016 to V3.0 09/12/2016 with more clarification about eligibility criteria, trial assessments, IMP management, prohibited medications, and translational research; Revision of PIS/Content Form V1.0 16/10 2016 to V2.0 09/12/2016 to reflect changes to the protocol; Revision of Participant Diary Card V1.0 to V2.0 07/12/2016 and Follow up Patient diary card (weeks 25-60) V1.0 121114 to V2.0 07/12/2016; Revision of Investigator Brochure (IB) for the IMP Vandetanib: Ed. 15 18/12/2013 to be used for DSUR reporting period 15/01/2015 to 14/01/2017; updated IB Ed. 16 dated 21/01/2015 and Ed. 17 dated 02/02/2016; Updated IBs for nIMP Fulvestrant Ed.17 dated 02/06/2014 and Ed.18 dated 18/08/2015; Notification of the divestment of the IMP (Vandetanib) from AstraZeneca to Genzyme

    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.
    No limitations

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/39516358
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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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