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    Clinical Trial Results:
    A Randomised, Double-blind, Parallel-group, Multicentre, Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant (FASLODEXTM) 250 mg, Fulvestrant (FASLODEXTM) 250 mg (plus 250 mg Loading Regimen) and Fulvestrant (FASLODEXTM) 500 mg in Postmenopausal Women with Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine Therapy

    Summary
    EudraCT number
    2005-004247-54
    Trial protocol
    BE   HU   CZ  
    Global end of trial date
    13 Mar 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Mar 2020
    First version publication date
    29 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D6997C00006
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Alderley Park, Macclesfield, United Kingdom, ST10 4TG
    Public contact
    Faslodex Medical science director, AstraZeneca, +1 877-400-4656, clinicaltrialtransparency@astrazeneca.com
    Scientific contact
    Faslodex Medical science director, AstraZeneca, +1 877-400-4656, clinicaltrialtransparency@astrazeneca.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
    13 Jun 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jun 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the objective response rate (ORR) of patients treated with fulvestrant 250 mg, fulvestrant 250 mg (plus 250 mg loading regimen) and fulvestrant 500 mg.
    Protection of trial subjects
    The final Clinical Study Protocol, including the final version of the Informed Consent Form had to be approved or given a favourable opinion in writing by an IEC as appropriate. The site investigators were required to submit written approval to AstraZeneca before they could enrol any patient into the study. The Principal Investigator at each site was responsible for informing the IEC of any amendment to the protocol in accordance with local requirements. In addition, all advertising used to recruit patients for the study had to be approved by the IEC. The protocol had to be re-approved by the IEC annually, as local regulations required.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 May 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    10 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 30
    Country: Number of subjects enrolled
    Canada: 31
    Country: Number of subjects enrolled
    Czech Republic: 8
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Hungary: 24
    Country: Number of subjects enrolled
    Poland: 29
    Country: Number of subjects enrolled
    Romania: 10
    Country: Number of subjects enrolled
    Turkey: 3
    Worldwide total number of subjects
    144
    EEA total number of subjects
    110
    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)
    58
    From 65 to 84 years
    83
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    The planned population size was 135 recruited patients. In total 144 patients were randomised in the study from 34 centres in 8 countries. The first patient was randomised into the study on 30 May 2006 and the last patient was randomised on 30 November 2007.

    Pre-assignment
    Screening details
    In total 161 patients were enrolled and 17 of them were not randomised.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Fulvestrant 250 mg
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Fulvestrant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    250 mg fulvestrant (1 fulvestrant injection and 1 placebo injection) was to be given on Days 0, 28 (±3) and every 28 (±3) days; 2 placebo injections were given on Day 14 (±3 days). Time windows extended to ±7 days after 24 weeks

    Arm title
    Fulvestrant 250 mg + Loading Dose
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Fulvestrant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    An initial dose of 500 mg (2 fulvestrant injections) was to be given on Day 0, followed by 250 mg (1 fulvestrant injection and 1 placebo injection) on Days 14 (±3), 28 (±3) and every 28 (±3) days. Time windows extended to ±7 days after 24 weeks

    Arm title
    Fulvestrant 500 mg
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Fulvestrant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    500 mg fulvestrant (2 fulvestrant injections) was to be given on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days. Time windows extended to ±7 days after 24 weeks.

    Number of subjects in period 1
    Fulvestrant 250 mg Fulvestrant 250 mg + Loading Dose Fulvestrant 500 mg
    Started
    47
    51
    46
    Completed
    47
    51
    46
    Period 2
    Period 2 title
    Treatment Period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Fulvestrant 250 mg
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Fulvestrant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    250 mg fulvestrant (1 fulvestrant injection and 1 placebo injection) was to be given on Days 0, 28 (±3) and every 28 (±3) days; 2 placebo injections were given on Day 14 (±3 days). Time windows extended to ±7 days after 24 weeks

    Arm title
    Fulvestrant 250 mg + Loading Dose
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Fulvestrant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    An initial dose of 500 mg (2 fulvestrant injections) was to be given on Day 0, followed by 250 mg (1 fulvestrant injection and 1 placebo injection) on Days 14 (±3), 28 (±3) and every 28 (±3) days. Time windows extended to ±7 days after 24 weeks

    Arm title
    Fulvestrant 500 mg
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Fulvestrant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    500 mg fulvestrant (2 fulvestrant injections) was to be given on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days. Time windows extended to ±7 days after 24 weeks.

    Number of subjects in period 2
    Fulvestrant 250 mg Fulvestrant 250 mg + Loading Dose Fulvestrant 500 mg
    Started
    47
    51
    46
    Completed
    11
    17
    14
    Not completed
    36
    34
    32
         Consent withdrawn by subject
    1
    -
    1
         Disease progression
    31
    26
    27
         Death
    2
    4
    2
         Adverse event
    1
    2
    -
         Progression (investigators opinion)
    1
    -
    -
         Incorrect enrollment
    -
    2
    1
         Lost to follow-up
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fulvestrant 250 mg
    Reporting group description
    -

    Reporting group title
    Fulvestrant 250 mg + Loading Dose
    Reporting group description
    -

    Reporting group title
    Fulvestrant 500 mg
    Reporting group description
    -

    Reporting group values
    Fulvestrant 250 mg Fulvestrant 250 mg + Loading Dose Fulvestrant 500 mg Total
    Number of subjects
    47 51 46 144
    Age Categorical
    Full analysis set
    Units: Subjects
        Adults (18-64 years)
    24 14 20 58
        From 65-74 years
    16 21 20 57
        75 years and over
    7 16 6 29
    Age Continuous
    Full analysis set
    Units: years
        median (full range (min-max))
    63 (42 to 88) 69 (38 to 85) 67 (49 to 85) -
    Gender Categorical
    Full analysis set
    Units: Subjects
        Female
    47 51 46 144
    Race/Ethnicity
    Full analysis set
    Units: Subjects
        Caucasian
    45 51 46 142
        Oriental (Japanese)
    1 0 0 1
        Oriental (Asian other than Chinese or Japanese)
    1 0 0 1
    Age
    Full analysis set
    Units: Years
        arithmetic mean (standard deviation)
    63.7 ± 9.9 68.1 ± 9.9 65.5 ± 9.0 -
    Weight
    Full analysis set
    Units: kg
        arithmetic mean (standard deviation)
    71.6 ± 17.2 71.7 ± 13.4 70.8 ± 12.9 -
    BMI
    Full analysis set
    Units: kg/m2
        arithmetic mean (standard deviation)
    27.7 ± 6.3 28.0 ± 4.8 27.3 ± 4.2 -

    End points

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    End points reporting groups
    Reporting group title
    Fulvestrant 250 mg
    Reporting group description
    -

    Reporting group title
    Fulvestrant 250 mg + Loading Dose
    Reporting group description
    -

    Reporting group title
    Fulvestrant 500 mg
    Reporting group description
    -
    Reporting group title
    Fulvestrant 250 mg
    Reporting group description
    -

    Reporting group title
    Fulvestrant 250 mg + Loading Dose
    Reporting group description
    -

    Reporting group title
    Fulvestrant 500 mg
    Reporting group description
    -

    Subject analysis set title
    PK analysis set
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Includes all patients who consented to blood draws for the analysis of fulvestrant plasma concentrations and have at least one evaluable blood sample drawn after baseline for the purpose of measuring fulvestrant plasma levels.

    Primary: Objective Response Rate (ORR)

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    End point title
    Objective Response Rate (ORR) [1]
    End point description
    Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).
    End point type
    Primary
    End point timeframe
    The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
    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: 95% CI are provided, there was no other analysis for the primary endpoint.
    End point values
    Fulvestrant 250 mg Fulvestrant 250 mg + Loading Dose Fulvestrant 500 mg
    Number of subjects analysed
    47
    51
    46
    Units: Percentage of patients
    number (confidence interval)
        Percentage (%)
    8.5 (2.4 to 20.4)
    5.9 (1.2 to 16.2)
    15.2 (6.3 to 28.9)
    No statistical analyses for this end point

    Secondary: Time to Progression (TTP)

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    End point title
    Time to Progression (TTP)
    End point description
    Time from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method. RECIST tumor assessments were carried out every 12 weeks until progression.
    End point type
    Secondary
    End point timeframe
    The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
    End point values
    Fulvestrant 250 mg Fulvestrant 250 mg + Loading Dose Fulvestrant 500 mg
    Number of subjects analysed
    47
    51
    46
    Units: Days
        median (inter-quartile range (Q1-Q3))
    88 (79 to 260)
    172 (80 to 339)
    169 (82 to 477)
    No statistical analyses for this end point

    Secondary: Duration of Response (DoR)

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    End point title
    Duration of Response (DoR)
    End point description
    DoR was defined as the time from date of first documentation of the response (CR or PR) until the date of disease progression or death from any cause.
    End point type
    Secondary
    End point timeframe
    The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
    End point values
    Fulvestrant 250 mg Fulvestrant 250 mg + Loading Dose Fulvestrant 500 mg
    Number of subjects analysed
    4 [2]
    3 [3]
    7 [4]
    Units: Days
        median (inter-quartile range (Q1-Q3))
    9999999 (9999999 to 9999999)
    9999999 (66 to 9999999)
    539 (539 to 539)
    Notes
    [2] - Only patients with response are analysed
    [3] - Only patients with response are analysed
    [4] - Only patients with response are analysed
    No statistical analyses for this end point

    Secondary: Clinical Benefit Rate (CBR)

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    End point title
    Clinical Benefit Rate (CBR)
    End point description
    CBR was defined as the proportion of all randomised patients who had clinical benefit (response of CR, PR or SD>=24 weeks).
    End point type
    Secondary
    End point timeframe
    The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.
    End point values
    Fulvestrant 250 mg Fulvestrant 250 mg + Loading Dose Fulvestrant 500 mg
    Number of subjects analysed
    47
    51
    46
    Units: Percentage of patients
        number (confidence interval)
    31.9 (19.1 to 47.1)
    47.1 (32.9 to 61.5)
    47.8 (32.9 to 63.1)
    No statistical analyses for this end point

    Secondary: Pharmacokinetic Parameter: Mean population clearance, a measure of the efficiency with which Fulvestrant is eliminated from the body

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    End point title
    Pharmacokinetic Parameter: Mean population clearance, a measure of the efficiency with which Fulvestrant is eliminated from the body
    End point description
    A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean.
    End point type
    Secondary
    End point timeframe
    Baseline to 12 weeks
    End point values
    PK analysis set
    Number of subjects analysed
    72
    Units: litres per hour
        least squares mean (standard error)
    31 ± 3.29
    No statistical analyses for this end point

    Secondary: Pharmacokinetic Parameter: Mean volume of distribution at steady state, a measure of the apparent volume in the body into which Fulvestrant distributes

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    End point title
    Pharmacokinetic Parameter: Mean volume of distribution at steady state, a measure of the apparent volume in the body into which Fulvestrant distributes
    End point description
    A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean. The mean estimate of volume of distribution at steady state was reported as the sum of V1/F and V2/F in the clinical study report.
    End point type
    Secondary
    End point timeframe
    Baseline to 12 weeks
    End point values
    PK analysis set
    Number of subjects analysed
    72
    Units: litres
    least squares mean (standard error)
        V1/F
    20600 ± 3.67
        V2/F
    35700 ± 27.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomisation to the point of data cut off for primary analysis
    Adverse event reporting additional description
    1 patient randomized to 250mg + LD arm was excluded from safety due to no treatment received All-Cause Mortality: patients who died whilst whilst on treatment or during 56 days following the last fulvestrant injection Serious Adverse Events: SAEs and AEs leading to death Deaths Resulting From AE = deaths causally related to AE per investiga
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Fulvestrant 250 mg
    Reporting group description
    -

    Reporting group title
    Fulvestrant 250 mg + Loading Dose
    Reporting group description
    -

    Reporting group title
    Fulvestrant 500 mg
    Reporting group description
    -

    Serious adverse events
    Fulvestrant 250 mg Fulvestrant 250 mg + Loading Dose Fulvestrant 500 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 47 (8.51%)
    9 / 50 (18.00%)
    4 / 46 (8.70%)
         number of deaths (all causes)
    2
    4
    2
         number of deaths resulting from adverse events
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell lung cancer
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscus lesion
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 50 (0.00%)
    0 / 46 (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
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 50 (2.00%)
    0 / 46 (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
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 50 (0.00%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 50 (2.00%)
    0 / 46 (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
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Eye disorders
    Macular hole
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 50 (0.00%)
    0 / 46 (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
    Gastrointestinal disorders
    Diverticulum intestinal hemorrhagic
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 50 (2.00%)
    0 / 46 (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
    Melaena
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 50 (2.00%)
    0 / 46 (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
    Pleural effusion
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 50 (4.00%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 50 (2.00%)
    0 / 46 (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
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 50 (2.00%)
    0 / 46 (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
    Pulmonary embolism
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 50 (2.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 50 (2.00%)
    0 / 46 (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
    Mental disorder
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 50 (0.00%)
    0 / 46 (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
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         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
    Fulvestrant 250 mg Fulvestrant 250 mg + Loading Dose Fulvestrant 500 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 47 (76.60%)
    35 / 50 (70.00%)
    31 / 46 (67.39%)
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    6 / 50 (12.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    6
    0
    Vascular disorders
    Hot flush
         subjects affected / exposed
    9 / 47 (19.15%)
    5 / 50 (10.00%)
    3 / 46 (6.52%)
         occurrences all number
    12
    5
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 47 (2.13%)
    3 / 50 (6.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    3
    0
    Headache
         subjects affected / exposed
    5 / 47 (10.64%)
    4 / 50 (8.00%)
    3 / 46 (6.52%)
         occurrences all number
    9
    5
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 47 (10.64%)
    4 / 50 (8.00%)
    4 / 46 (8.70%)
         occurrences all number
    5
    4
    4
    Fatigue
         subjects affected / exposed
    4 / 47 (8.51%)
    11 / 50 (22.00%)
    7 / 46 (15.22%)
         occurrences all number
    7
    12
    7
    Injection site pain
         subjects affected / exposed
    6 / 47 (12.77%)
    7 / 50 (14.00%)
    6 / 46 (13.04%)
         occurrences all number
    7
    12
    7
    Oedema peripheral
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 50 (6.00%)
    2 / 46 (4.35%)
         occurrences all number
    3
    3
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    3 / 47 (6.38%)
    3 / 50 (6.00%)
    2 / 46 (4.35%)
         occurrences all number
    3
    3
    3
    Abdominal pain
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 50 (6.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    3
    1
    Diarrhoea
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 50 (8.00%)
    6 / 46 (13.04%)
         occurrences all number
    3
    4
    7
    Nausea
         subjects affected / exposed
    12 / 47 (25.53%)
    9 / 50 (18.00%)
    7 / 46 (15.22%)
         occurrences all number
    13
    9
    9
    Vomiting
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 50 (8.00%)
    5 / 46 (10.87%)
         occurrences all number
    3
    7
    5
    Constipation
         subjects affected / exposed
    3 / 47 (6.38%)
    7 / 50 (14.00%)
    1 / 46 (2.17%)
         occurrences all number
    3
    7
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 47 (12.77%)
    6 / 50 (12.00%)
    4 / 46 (8.70%)
         occurrences all number
    6
    6
    4
    Dysphonia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 50 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    3
    Dyspnoea
         subjects affected / exposed
    6 / 47 (12.77%)
    6 / 50 (12.00%)
    5 / 46 (10.87%)
         occurrences all number
    7
    7
    5
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 50 (2.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    1
    3
    Pruritus
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 50 (2.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    1
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 47 (4.26%)
    5 / 50 (10.00%)
    2 / 46 (4.35%)
         occurrences all number
    2
    6
    2
    Depression
         subjects affected / exposed
    3 / 47 (6.38%)
    3 / 50 (6.00%)
    1 / 46 (2.17%)
         occurrences all number
    3
    3
    1
    Renal and urinary disorders
    Urinary incontinence
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 50 (6.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    3
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 47 (8.51%)
    7 / 50 (14.00%)
    4 / 46 (8.70%)
         occurrences all number
    4
    8
    4
    Back pain
         subjects affected / exposed
    5 / 47 (10.64%)
    8 / 50 (16.00%)
    7 / 46 (15.22%)
         occurrences all number
    8
    8
    8
    Musculoskeletal chest pain
         subjects affected / exposed
    4 / 47 (8.51%)
    3 / 50 (6.00%)
    0 / 46 (0.00%)
         occurrences all number
    4
    4
    0
    Musculoskeletal pain
         subjects affected / exposed
    3 / 47 (6.38%)
    2 / 50 (4.00%)
    2 / 46 (4.35%)
         occurrences all number
    3
    2
    2
    Myalgia
         subjects affected / exposed
    6 / 47 (12.77%)
    1 / 50 (2.00%)
    2 / 46 (4.35%)
         occurrences all number
    6
    2
    2
    Pain in extremity
         subjects affected / exposed
    5 / 47 (10.64%)
    5 / 50 (10.00%)
    0 / 46 (0.00%)
         occurrences all number
    10
    6
    0
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 50 (6.00%)
    0 / 46 (0.00%)
         occurrences all number
    2
    3
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 47 (2.13%)
    3 / 50 (6.00%)
    1 / 46 (2.17%)
         occurrences all number
    1
    3
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 50 (6.00%)
    3 / 46 (6.52%)
         occurrences all number
    4
    3
    3
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    2 / 47 (4.26%)
    4 / 50 (8.00%)
    3 / 46 (6.52%)
         occurrences all number
    2
    5
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Feb 2008
    The estimated date of last patient completed was corrected to account for the follow-up procedure for patients still receiving clinical benefit, in the opinion of the investigator, after the data cut-off for the primary analysis. Follow-up procedures post DCO for the primary analysis were clarified.
    12 Feb 2010
    The primary statistical analysis of the fulvestrant “CONFIRM” study (D6997C00002, CSR dated 09 July 2009), showed a clinically and statistically significant advantage for the 500 mg fulvestrant dose group compared to the 250 mg dose group with respect to the primary endpoint of time to progression (TTP), with no clinically significant differences in adverse events in the 500 mg dose group compared to the 250 mg group. The CONFIRM Independent Data Monitoring Committee (IDMC) reviewed these results and recommended that all patients who remain on fulvestrant 250 mg, be given the option to transfer to fulvestrant 500 mg. Dr. Angelo Di Leo, the CONFIRM International Coordinating Investigator, has endorsed this position and agreed that patients receiving fulvestrant 250mg should be assessed on an individual basis by their treating physician, and if both agree, the patient will be transferred to fulvestrant 500 mg. Ongoing patients on the FINDER2 trial are currently receiving open label supplies. Patients who are currently receiving the fulvestrant 250 mg will be given the option of transferring to fulvestrant 500 mg. Patients wishing to transfer to the higher dose will be asked to provide re-consent as required by the AstraZeneca Informed Consent Process. No further analysis will be performed for this study.

    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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