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    Clinical Trial Results:
    A Phase 3, Double-Blind, Randomized, Parallel-Group, Active-Controlled Study to Compare the Efficacy and Safety of CT-P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients with HER2-Positive Early Breast Cancer

    Summary
    EudraCT number
    		 2013-004525-84
    Trial protocol
    		 LV   GR   HU   ES   IT   PT   RO   PL   HR  
    Global end of trial date
    23 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Oct 2019
    First version publication date
    06 Oct 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CT-P6 3.2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02162667
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CELLTRION, Inc.
    Sponsor organisation address
    23, Academy-ro, Yeonsu-gu, Incheon, Korea, Republic of, 22014
    Public contact
    CELLTRION, Inc., CELLTRION, Inc., +82 850 5000, contact@celltrion.com
    Scientific contact
    CELLTRION, Inc., CELLTRION, Inc., +82 850 5000, contact@celltrion.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
    23 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to demonstrate equivalence of CT-P6 and Herceptin, both given in combination with docetaxel (75 mg/m2, Cycles 1 to 4) followed by FEC (5-fluorouracil 500 mg/m2, epirubicin 75 mg/m2, and cyclophosphamide 500 mg/m2, Cycles 5 to 8), in terms of efficacy as determined by pathological complete response (pCR), in patients with HER2-positive operable early breast cancer.
    Protection of trial subjects
    The study was conducted according to the principles of the International Council for Harmonisation (ICH) harmonised tripartite guideline E6(R1): Good Clinical Practice (GCP) (ICH 1996) and the ethical principles that have their origin in the World Medical Association Declaration of Helsinki. The investigators agreed to conduct all aspects of this study in accordance with national, state, and local laws or regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Aug 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 3
    Country: Number of subjects enrolled
    Belarus: 54
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 1
    Country: Number of subjects enrolled
    Chile: 8
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Georgia: 59
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    India: 24
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Japan: 30
    Country: Number of subjects enrolled
    Latvia: 5
    Country: Number of subjects enrolled
    Mexico: 5
    Country: Number of subjects enrolled
    Peru: 6
    Country: Number of subjects enrolled
    Philippines: 35
    Country: Number of subjects enrolled
    Poland: 30
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Romania: 31
    Country: Number of subjects enrolled
    Russian Federation: 159
    Country: Number of subjects enrolled
    South Africa: 17
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Taiwan: 7
    Country: Number of subjects enrolled
    Ukraine: 61
    Worldwide total number of subjects
    549
    EEA total number of subjects
    80
    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)
    478
    From 65 to 84 years
    71
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 112 study centers were included in Europe, the Middle East, and Africa (EMEA), Asia Pacific, and Latin America and 99 study centers randomized subjects.

    Pre-assignment
    Screening details
    		 This study will include females 18 years of age or older with pathologically confirmed, newly diagnosed, operable early breast cancer (Stage I, II, or IIIa).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P6
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trastuzumab (CT-P6, Herzuma)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    8 mg/kg body weight on Day 1 of Neoadjuvant Period Cycle 1, followed by 6 mg/kg body weight repeated every 3 weeks for 8 cycles

    Arm title
    		 Herceptin
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Trastuzumab (Herceptin)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    8 mg/kg body weight on Day 1 of Neoadjuvant Period Cycle 1, followed by 6 mg/kg body weight repeated every 3 weeks for 8 cycles

    Number of subjects in period 1
    		CT-P6 Herceptin
    Started
    271
    278
    Completed
    258
    261
    Not completed
    13
    17
         Adverse event, serious fatal
    2
    1
         Consent withdrawn by subject
    2
    3
         Physician decision
    -
    1
         Adverse event, non-fatal
    5
    8
         Missing primary endpoint
    1
    1
         Protocol deviation
    1
    3
         Lack of efficacy
    2
    -
    Period 2
    Period 2 title
    Adjuvant Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P6
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trastuzumab (CT-P6, Herzuma)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/kg body weight repeated every 3 weeks up to 1 year from the first day of study drug administered in the Neoadjuvant Period

    Arm title
    		 Herceptin
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Trastuzumab (Herceptin)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/kg body weight repeated every 3 weeks up to 1 year from the first day of study drug administered in the Neoadjuvant Period

    Number of subjects in period 2 [1]
    		CT-P6 Herceptin
    Started
    254
    262
    Completed
    243
    249
    Not completed
    11
    13
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    4
    2
         Adverse event, non-fatal
    2
    3
         Other
    -
    2
         Lack of efficacy
    5
    4
         Protocol deviation
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: There were two patients (one in Arm CT-P6 and another in Arm Herceptin) who entered the Adjuvant Period after completing the Neoadjuvant Period without assessing the primary endpoint. After period 1 (Neoadjuvant Period with primary endpoint assessment), four patients in Arm CT-P6 withdrew and did not enter the Adjuvant Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CT-P6
    Reporting group description
    		 -

    Reporting group title
    Herceptin
    Reporting group description
    		 -

    Reporting group values
    		 CT-P6 Herceptin Total
    Number of subjects
    		 271 278 549
    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)
    		 240 238 478
        From 65-84 years
    		 31 40 71
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 53 (24 to 78) 53 (22 to 74) -
    Gender categorical
    Units: Subjects
        Female
    		 271 278 549
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Per protocol set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients in the ITT set, except for those patients excluded because of major protocol deviations. A major protocol deviation was one that may have affected the interpretation of study results; major protocol deviations were defined in the statistical analysis plan.

    Subject analysis sets values
    		 Per protocol set (PPS)
    Number of subjects
    504
    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)
    441
        From 65-84 years
    63
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    CT-P6
    Reporting group description
    		 -

    Reporting group title
    Herceptin
    Reporting group description
    		 -
    Reporting group title
    CT-P6
    Reporting group description
    		 -

    Reporting group title
    Herceptin
    Reporting group description
    		 -

    Subject analysis set title
    Per protocol set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients in the ITT set, except for those patients excluded because of major protocol deviations. A major protocol deviation was one that may have affected the interpretation of study results; major protocol deviations were defined in the statistical analysis plan.

    Primary: Pathological complete response (pCR)

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    End point title
    		 Pathological complete response (pCR)
    End point description
    The pCR which is defined as the absence of invasive tumor cells in the breast and in axillary lymph nodes, regardless of the ductal carcinoma in situ (DCIS) was the primary efficacy endpoint.
    End point type
    Primary
    End point timeframe
    at the time of surgery after 8 cycles of treatment (4 cycles of CT-P6 or Herceptin with docetaxel followed by 4 cycles of CT-P6 or Herceptin with FEC)
    End point values
    		 CT-P6 Herceptin Per protocol set (PPS)
    Number of subjects analysed
    248
    256
    504
    Units: pCR Rate
        Number of Responders
    116
    129
    245
        Number of Non-Responders
    132
    127
    259
    Statistical analysis title
    		 pCR (Per protocol set)
    Comparison groups
    CT-P6 v Herceptin
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.0362
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1238
         upper limit
    		 0.0516
    Notes
    [1] - Equivalence margin: (-0.15 - 0.15)

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    CT-P6
    Reporting group description
    		 -

    Reporting group title
    Herceptin
    Reporting group description
    		 -

    Serious adverse events
    		 CT-P6 Herceptin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 271 (7.75%)
    35 / 278 (12.59%)
         number of deaths (all causes)
    18
    18
         number of deaths resulting from adverse events
    2
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 271 (0.00%)
    2 / 278 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian germ cell teratoma benign
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Deep vein thrombosis
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Implant site extravasation
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Complications of transplant surgery
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scar
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Adams-Stokes syndrome
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 271 (0.37%)
    3 / 278 (1.08%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    6 / 271 (2.21%)
    3 / 278 (1.08%)
         occurrences causally related to treatment / all
    4 / 6
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 271 (0.74%)
    3 / 278 (1.08%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Neurodermatitis
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 271 (0.37%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 271 (0.00%)
    2 / 278 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 271 (0.74%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic embolus
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 278 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CT-P6 Herceptin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    263 / 271 (97.05%)
    263 / 278 (94.60%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    19 / 271 (7.01%)
    11 / 278 (3.96%)
         occurrences all number
    19
    13
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    47 / 271 (17.34%)
    38 / 278 (13.67%)
         occurrences all number
    117
    99
    Fatigue
         subjects affected / exposed
    53 / 271 (19.56%)
    62 / 278 (22.30%)
         occurrences all number
    134
    179
    Oedema peripheral
         subjects affected / exposed
    8 / 271 (2.95%)
    18 / 278 (6.47%)
         occurrences all number
    11
    26
    Pyrexia
         subjects affected / exposed
    31 / 271 (11.44%)
    30 / 278 (10.79%)
         occurrences all number
    42
    40
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    14 / 271 (5.17%)
    14 / 278 (5.04%)
         occurrences all number
    16
    16
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    16 / 271 (5.90%)
    7 / 278 (2.52%)
         occurrences all number
    16
    8
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    18 / 271 (6.64%)
    30 / 278 (10.79%)
         occurrences all number
    24
    43
    Aspartate aminotransferase increased
         subjects affected / exposed
    14 / 271 (5.17%)
    25 / 278 (8.99%)
         occurrences all number
    17
    40
    Ejection fraction decreased
         subjects affected / exposed
    20 / 271 (7.38%)
    9 / 278 (3.24%)
         occurrences all number
    24
    11
    Neutrophil count decreased
         subjects affected / exposed
    14 / 271 (5.17%)
    13 / 278 (4.68%)
         occurrences all number
    34
    42
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    31 / 271 (11.44%)
    28 / 278 (10.07%)
         occurrences all number
    47
    37
    Radiation skin injury
         subjects affected / exposed
    33 / 271 (12.18%)
    34 / 278 (12.23%)
         occurrences all number
    34
    35
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    14 / 271 (5.17%)
    8 / 278 (2.88%)
         occurrences all number
    15
    14
    Headache
         subjects affected / exposed
    25 / 271 (9.23%)
    21 / 278 (7.55%)
         occurrences all number
    35
    28
    Peripheral sensory neuropathy
         subjects affected / exposed
    14 / 271 (5.17%)
    20 / 278 (7.19%)
         occurrences all number
    19
    24
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    59 / 271 (21.77%)
    66 / 278 (23.74%)
         occurrences all number
    98
    125
    Febrile neutropenia
         subjects affected / exposed
    11 / 271 (4.06%)
    16 / 278 (5.76%)
         occurrences all number
    11
    18
    Leukopenia
         subjects affected / exposed
    28 / 271 (10.33%)
    40 / 278 (14.39%)
         occurrences all number
    45
    92
    Neutropenia
         subjects affected / exposed
    95 / 271 (35.06%)
    115 / 278 (41.37%)
         occurrences all number
    216
    255
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    16 / 271 (5.90%)
    15 / 278 (5.40%)
         occurrences all number
    34
    35
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    24 / 271 (8.86%)
    18 / 278 (6.47%)
         occurrences all number
    43
    26
    Diarrhoea
         subjects affected / exposed
    52 / 271 (19.19%)
    50 / 278 (17.99%)
         occurrences all number
    75
    75
    Nausea
         subjects affected / exposed
    99 / 271 (36.53%)
    94 / 278 (33.81%)
         occurrences all number
    281
    284
    Stomatitis
         subjects affected / exposed
    46 / 271 (16.97%)
    33 / 278 (11.87%)
         occurrences all number
    72
    45
    Vomiting
         subjects affected / exposed
    27 / 271 (9.96%)
    26 / 278 (9.35%)
         occurrences all number
    40
    46
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    196 / 271 (72.32%)
    213 / 278 (76.62%)
         occurrences all number
    269
    293
    Rash
         subjects affected / exposed
    18 / 271 (6.64%)
    10 / 278 (3.60%)
         occurrences all number
    20
    14
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    34 / 271 (12.55%)
    40 / 278 (14.39%)
         occurrences all number
    53
    65
    Bone pain
         subjects affected / exposed
    11 / 271 (4.06%)
    20 / 278 (7.19%)
         occurrences all number
    13
    34
    Myalgia
         subjects affected / exposed
    27 / 271 (9.96%)
    28 / 278 (10.07%)
         occurrences all number
    50
    47
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    17 / 271 (6.27%)
    8 / 278 (2.88%)
         occurrences all number
    23
    11
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    21 / 271 (7.75%)
    20 / 278 (7.19%)
         occurrences all number
    49
    28

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Dec 2014
    -Clinical response rate and radiological response rate were combined as tumor response rate additional since CT assessment was added after Neoadjuvant Period Cycle 4. The relevant text was updated accordingly.

    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.
    N/A

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28592386
    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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