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    Clinical Trial Results:
    A Randomized, Double-Blind Pharmacokinetic Study Of PF 05280014 Plus Taxotere® And Carboplatin Versus Herceptin® Plus Taxotere® And Carboplatin For The Neoadjuvant Treatment Of Patients With Operable HER2 Positive Breast Cancer.

    Summary
    EudraCT number
    		 2013-004679-11
    Trial protocol
    		 IT   SK   CZ   HU   PL  
    Global end of trial date
    09 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Mar 2017
    First version publication date
    16 Mar 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B3271004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 East 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer CT.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer CT.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    26 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the percentage of participants with steady state (Cycle 5) trough plasma concentration (Ctrough) >20 μg/mL for PF 05280014 versus trastuzumab-EU in patients with operable HER2-positive breast cancer who received study therapy together with Taxotere and carboplatin in the neoadjuvant setting.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation Good Clinical Practice Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial participants. A signed and dated informed consent was required before any screening procedures were done, with the exception of radiographic tumor assessments (which were performed as part of routine procedures within 6 weeks prior to randomization and in accordance with protocol method/documentation requirements). Appropriate documentation indicating that these radiographic tumor assessments were performed as standard of care were available in the patient’s source notes. The investigators explained the nature, purpose, and risks of the study to each participant. Each participant was informed that she could withdraw from the study at any time and for any reason. Each participant was given sufficient time to consider the implications of the study before deciding whether to participate.
    Background therapy
    		 Taxotere was administered every 3 weeks on Day 1 of each cycle. The starting dose of Taxotere was 75 mg/m2 administered IV over 60 minutes. Carboplatin was administered every 3 weeks on Day 1 of each cycle.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Sep 2014
    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
    Belarus: 2
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Hungary: 17
    Country: Number of subjects enrolled
    Italy: 15
    Country: Number of subjects enrolled
    Poland: 25
    Country: Number of subjects enrolled
    Russian Federation: 117
    Country: Number of subjects enrolled
    Serbia: 1
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Ukraine: 40
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    225
    EEA total number of subjects
    62
    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)
    183
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was initiated at 67 sites in 10 countries (across Europe and the United States [US]), of which 21 sites had no enrollment activity. Advertisements approved by ethics committees and investigator databases may be used as recruitment procedures. All advertisements must have been approved by the study Sponsor prior to use.

    Pre-assignment
    Screening details
    		 Informed consent must have been obtained before any study specific procedures were performed (with the exception of certain imaging assessments if meeting the protocol specified criteria); however, it may be obtained more than 28 days before randomization.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PF-05280014
    Arm description
    		 Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin area under the concentration versus time curve (AUC) 6 were administered on Day 1 of each cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-05280014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The first administration of PF-05280014 on Day 1, Cycle 1 was a loading dose of 8 mg/kg infused over 90 minutes. The duration of infusion could be lengthened according to local standard of care or tolerability. Subsequent infusions followed every 3 weeks (ie, cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability. In the absence of objective disease progression or prohibitive toxicity, patients received PF-05280014 for 6 cycles.

    Arm title
    		 Trastuzumab-EU
    Arm description
    		 Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Trastuzumab-EU
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The first administration of trastuzumab-EU on Day 1, Cycle 1 was a loading dose of 8 mg/kg infused over 90 minutes. The duration of infusion could be lengthened according to local standard of care or tolerability. Subsequent infusions followed every 3 weeks (ie, cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability. In the absence of objective disease progression or prohibitive toxicity, patients received trastuzumab-EU for 6 cycles.

    Number of subjects in period 1
    		PF-05280014 Trastuzumab-EU
    Started
    113
    112
    Completed
    109
    106
    Not completed
    4
    6
         Adverse event, serious fatal
    1
    -
         NotSpecified
    2
    1
         Participant refused further follow-up
    1
    -
         Related adverse event, serious non-fatal
    -
    1
         Lost to follow-up
    -
    2
         Related adverse event, not serious
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-05280014
    Reporting group description
    		 Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin area under the concentration versus time curve (AUC) 6 were administered on Day 1 of each cycle.

    Reporting group title
    Trastuzumab-EU
    Reporting group description
    		 Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.

    Reporting group values
    		 PF-05280014 Trastuzumab-EU Total
    Number of subjects
    		 113 112 225
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 88 95 183
        From 65-84 years
    		 25 17 42
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 54.2 ( 11.7 ) 51.2 ( 12.7 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 113 112 225

    End points

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    End points reporting groups
    Reporting group title
    PF-05280014
    Reporting group description
    		 Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin area under the concentration versus time curve (AUC) 6 were administered on Day 1 of each cycle.

    Reporting group title
    Trastuzumab-EU
    Reporting group description
    		 Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.

    Primary: Percentage of Participants with Steady State Drug Concentration Ctrough (Cycle 6 pre-dose) >20 µg/mL at Cycle 5.

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    End point title
    		 Percentage of Participants with Steady State Drug Concentration Ctrough (Cycle 6 pre-dose) >20 µg/mL at Cycle 5.
    End point description
    The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) >20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group.
    End point type
    Primary
    End point timeframe
    Cycle 5
    End point values
    		 PF-05280014 Trastuzumab-EU
    Number of subjects analysed
    101
    89
    Units: Percentage of participants
        number (confidence interval 95%)
    92.1 (85 to 96.5)
    93.3 (85.9 to 97.5)
    Statistical analysis title
    		 Estimated difference (stratified)
    Statistical analysis description
    Stratified estimated difference between PF-05280014 and Trastuzuamb-EU.
    Comparison groups
    PF-05280014 v Trastuzumab-EU
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.02
         upper limit
    		 6.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.7
    Notes
    [1] - The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough >20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.
    Statistical analysis title
    		 Estimated difference (unstratified)
    Statistical analysis description
    Unstratified estimated difference between PF-05280014 and Trastuzuamb-EU.
    Comparison groups
    PF-05280014 v Trastuzumab-EU
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.59
         upper limit
    		 6.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.78
    Notes
    [2] - The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough >20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.

    Secondary: Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 through 6.

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    End point title
    		 Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 through 6.
    End point description
    Samples of blood were taken pre-dose on Cycles 1, 2, 4, 5, and 6, and at 1 hour post dose on Cycles 1 and 5 for pharmacokinetic evaluation.
    End point type
    Secondary
    End point timeframe
    Cycles 1 through 6
    End point values
    		 PF-05280014 Trastuzumab-EU
    Number of subjects analysed
    101
    89
    Units: μg/mL
    arithmetic mean (standard deviation)
        Cycle 1/Day 1 0 hours N= 101, 88
    2.313 ( 17.949 )
    1.318 ( 12.366 )
        Cycle 1/Day 1 1 hour N= 97, 80
    160.4 ( 57.329 )
    164.8 ( 47.033 )
        Cycle 2/Day 21 0 hours N= 99, 88
    24.29 ( 13.796 )
    27.2 ( 10.65 )
        Cycle 4/Day 63 0 hours N= 98, 89
    33.43 ( 14.488 )
    37.33 ( 15.629 )
        Cycle 5/Day 84 0 hours N= 101, 87
    35.01 ( 15.571 )
    40.44 ( 26.765 )
        Cycle 5/Day 84 1 hour N= 90, 80
    137 ( 37.748 )
    138.8 ( 37.417 )
        Cycle 6/Day 105 0 hours N= 101, 89
    37.77 ( 17.523 )
    40.1 ( 16.67 )
    No statistical analyses for this end point

    Secondary: Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes.

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    End point title
    		 Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes.
    End point description
    Following surgery after treatment completion, tumors were assessed as Complete Pathological Response, Partial Pathological Response, or No Pathological Response.
    End point type
    Secondary
    End point timeframe
    Cycle 6/End of treatment
    End point values
    		 PF-05280014 Trastuzumab-EU
    Number of subjects analysed
    100
    86
    Units: Percentage of participants
        number (confidence interval 95%)
    47 (36.9 to 57.2)
    50 (39 to 61)
    Statistical analysis title
    		 Estimated difference (stratified)
    Statistical analysis description
    Stratified estimated difference between PF-05280014 and Trastuzuamb-EU.
    Comparison groups
    PF-05280014 v Trastuzumab-EU
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.58
         upper limit
    		 10.96
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.03
    Notes
    [3] - Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.
    Statistical analysis title
    		 Estimated difference (unstratified)
    Statistical analysis description
    Unstratified estimated difference between PF-05280014 and Trastuzuamb-EU.
    Comparison groups
    PF-05280014 v Trastuzumab-EU
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.4
         upper limit
    		 11.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.35

    Secondary: Objective Response Rate (ORR) Defined as the Percentage of Participants having Complete or Partial Response at End of Treatment, Based on Radiographic Assessments of the Tumor.

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    End point title
    		 Objective Response Rate (ORR) Defined as the Percentage of Participants having Complete or Partial Response at End of Treatment, Based on Radiographic Assessments of the Tumor.
    End point description
    ORR was defined as Complete Response (CR), Partial Response (PR), Stable (SD), Progressive Disease (PD) or Indeterminate (IND). ORR was the percentage of participants who had CR or PR at Cycle 6/End of treatment.
    End point type
    Secondary
    End point timeframe
    Cycle 6/End of treatment
    End point values
    		 PF-05280014 Trastuzumab-EU
    Number of subjects analysed
    101
    89
    Units: Percentage of participants
        number (confidence interval 95%)
    88.1 (80.2 to 93.7)
    82 (72.5 to 89.4)
    Statistical analysis title
    		 Estimated difference (stratified)
    Statistical analysis description
    Stratified estimated difference between PF-05280014 and Trastuzuamb-EU.
    Comparison groups
    PF-05280014 v Trastuzumab-EU
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.01
         upper limit
    		 15.94
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.09
    Notes
    [4] - Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.
    Statistical analysis title
    		 Estimated difference (unstratified)
    Statistical analysis description
    Unstratified estimated difference between PF-05280014 and Trastuzuamb-EU.
    Comparison groups
    PF-05280014 v Trastuzumab-EU
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.08
         upper limit
    		 16.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.19

    Secondary: Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 through 6.

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    End point title
    		 Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 through 6.
    End point description
    The number of participants with positive (titer >=1.00) pre-dose ADA samples, participants counted towards the total if for at least one sample, the ADA was positive.
    End point type
    Secondary
    End point timeframe
    Cycles 1 through 6
    End point values
    		 PF-05280014 Trastuzumab-EU
    Number of subjects analysed
    113
    112
    Units: Number of participants
        Cycle 1 (n=113,112)
    0
    1
        Cycle 2 (n=111,112)
    0
    0
        Cycle 4 (n=108,109)
    0
    0
        Cycle 6 (n=108,108)
    0
    0
    No statistical analyses for this end point

    Secondary: Incidence of Neutralizing Antibodies (NAb) at Cycles 1 through 6.

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    End point title
    		 Incidence of Neutralizing Antibodies (NAb) at Cycles 1 through 6.
    End point description
    The number of participants with positive (NAb response >=1.48) pre-dose NAb samples, participants counted towards the total if for at least one sample, the NAb was positive.
    End point type
    Secondary
    End point timeframe
    Cycles 1 through 6
    End point values
    		 PF-05280014 Trastuzumab-EU
    Number of subjects analysed
    113
    112
    Units: Number of participants
        Cycle 1 (n=113,112)
    0
    0
        Cycle 2 (n=110,112)
    0
    0
        Cycle 4 (n=108,110)
    0
    0
        Cycle 6 (n=108,108)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events were captured from the beginning of the study drug treatment up to 6 months after the last dose. Treatment emergent adverse events were captured from the beginning of the study drug treatment up to 50 days after the last dose.
    Adverse event reporting additional description
    Treatment emergent adverse events were defined as any adverse event that occurred or any preexisting adverse event that worsened within the reporting time frame.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    PF-05280014
    Reporting group description
    		 Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.

    Reporting group title
    Trastuzumab-EU
    Reporting group description
    		 Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.

    Serious adverse events
    		 PF-05280014 Trastuzumab-EU
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 113 (6.19%)
    6 / 112 (5.36%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 113 (0.88%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Gastrointestinal disorders
    Proctitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Device related sepsis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection site abscess
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth infection
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PF-05280014 Trastuzumab-EU
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    106 / 113 (93.81%)
    106 / 112 (94.64%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    7 / 113 (6.19%)
    10 / 112 (8.93%)
         occurrences all number
    10
    14
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 113 (2.65%)
    7 / 112 (6.25%)
         occurrences all number
    4
    9
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    7 / 113 (6.19%)
    4 / 112 (3.57%)
         occurrences all number
    7
    4
    Dysgeusia
         subjects affected / exposed
    4 / 113 (3.54%)
    6 / 112 (5.36%)
         occurrences all number
    8
    12
    Neuropathy peripheral
         subjects affected / exposed
    6 / 113 (5.31%)
    4 / 112 (3.57%)
         occurrences all number
    7
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    56 / 113 (49.56%)
    51 / 112 (45.54%)
         occurrences all number
    114
    112
    Neutropenia
         subjects affected / exposed
    37 / 113 (32.74%)
    41 / 112 (36.61%)
         occurrences all number
    112
    139
    Leukopenia
         subjects affected / exposed
    16 / 113 (14.16%)
    25 / 112 (22.32%)
         occurrences all number
    59
    95
    Thrombocytopenia
         subjects affected / exposed
    16 / 113 (14.16%)
    19 / 112 (16.96%)
         occurrences all number
    30
    24
    Febrile neutropenia
         subjects affected / exposed
    3 / 113 (2.65%)
    6 / 112 (5.36%)
         occurrences all number
    4
    6
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    36 / 113 (31.86%)
    23 / 112 (20.54%)
         occurrences all number
    68
    46
    Fatigue
         subjects affected / exposed
    15 / 113 (13.27%)
    19 / 112 (16.96%)
         occurrences all number
    38
    34
    Pyrexia
         subjects affected / exposed
    6 / 113 (5.31%)
    5 / 112 (4.46%)
         occurrences all number
    9
    11
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    38 / 113 (33.63%)
    34 / 112 (30.36%)
         occurrences all number
    72
    75
    Diarrhoea
         subjects affected / exposed
    16 / 113 (14.16%)
    19 / 112 (16.96%)
         occurrences all number
    23
    33
    Vomiting
         subjects affected / exposed
    7 / 113 (6.19%)
    10 / 112 (8.93%)
         occurrences all number
    10
    16
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    72 / 113 (63.72%)
    69 / 112 (61.61%)
         occurrences all number
    88
    81
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    16 / 113 (14.16%)
    8 / 112 (7.14%)
         occurrences all number
    23
    13
    Bone pain
         subjects affected / exposed
    13 / 113 (11.50%)
    5 / 112 (4.46%)
         occurrences all number
    22
    13
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    13 / 113 (11.50%)
    9 / 112 (8.04%)
         occurrences all number
    16
    14

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Oct 2014
    Amendment 1 was implemented as a result of feedback from the E-DMC and Study B3271002 protocol Amendment 2, as well as Pfizer SOP updates.

    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.
    It was decided that the secondary study objective to explore the relationship between drug exposure and pCR for PF-05280014 versus trastuzumab-EU would not be analyzed.
    For support, Contact us.
    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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