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    Clinical Trial Results:
    A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC

    Summary
    EudraCT number
    		 2015-005663-17
    Trial protocol
    		 CZ   FR   BG   RO   PL  
    Global end of trial date
    21 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Apr 2022
    First version publication date
    06 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SB3-G31-BC-E
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02771795
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Samsung Bioepis Co., Ltd.
    Sponsor organisation address
    76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, Korea, Republic of,
    Public contact
    Quintiles Contact Centre, Quintiles Limited, 001 8622613634,
    Scientific contact
    Quintiles Contact Centre, Quintiles Limited, 001 8622613634,
    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
    21 Jan 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to observe the incidence of symptomatic congestive heart failure (CHF) NYHA class II,III and IV and asymptomatic LVEF decrease in patients who participated in the SB3-G31-BC Study and treated with SB3 ( proposed trastuzumab biosimilar) or Herceptin® as neoadjuvant and adjuvant treatment.
    Protection of trial subjects
    The study and clinical study protocols were reviewed and approved by Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for each study centre. This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki (2013) and that are consistent with the latest International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice (ICH E6 [R2] GCP) and applicable local regulatory requirements and laws.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Apr 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    India: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 64
    Country: Number of subjects enrolled
    Malaysia: 19
    Country: Number of subjects enrolled
    Philippines: 5
    Country: Number of subjects enrolled
    Russian Federation: 177
    Country: Number of subjects enrolled
    Ukraine: 104
    Country: Number of subjects enrolled
    Viet Nam: 9
    Country: Number of subjects enrolled
    Poland: 92
    Country: Number of subjects enrolled
    Romania: 28
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Czechia: 12
    Country: Number of subjects enrolled
    France: 16
    Worldwide total number of subjects
    538
    EEA total number of subjects
    151
    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)
    528
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who had received SB3 or Herceptin® according to the SB3-G31-BC study provided informed consent to participate in this study.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    There was no investigational product or a treatment administered to the subjects

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SB3 (proposed trastuzumab biosimilar)
    Arm description
    		 SB3 was administered in SB3-G31-BC study (2013-004172-35). No additional IP was administered for this study since it was an observational study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SB3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    SB3 was administered intravenously at a loading dose of 8 mg/kg and at a maintenance dose of 6 mg/kg for the subsequent cycles in SB3-G31-BC study.

    Arm title
    		 Herceptin
    Arm description
    		 Herceptin was administered in SB3-G31-BC study (2013-004172-35). No additional IP was administered for this study since it was an observational study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Herceptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Herceptin was administered intravenously at a loading dose of 8 mg/kg and at a maintenance dose of 6 mg/kg for the subsequent cycles in SB3-G31-BC study.

    Number of subjects in period 1
    		SB3 (proposed trastuzumab biosimilar) Herceptin
    Started
    267
    271
    Completed
    45
    56
    Not completed
    222
    215
         Termination by premature discontinuation of study
    185
    168
         Early termination during the study period
    37
    47

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 538 538
    Age categorical
    Units: Subjects
        Less than 60 years
    		 445 445
        60 years and over
    		 92 92
        Missing
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 538 538
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Survival Follow-up Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This set consisted of all subjects who enrolled for this study. This set included Cardiac Safety and Survival Cohort and Survival Only Cohort.

    Subject analysis sets values
    		 Survival Follow-up Set
    Number of subjects
    538
    Age categorical
    Units: Subjects
        Less than 60 years
    445
        60 years and over
    92
        Missing
    1
    Age continuous
    Units:
        
    49.95 ( 27 )
    Gender categorical
    Units: Subjects
        Female
    538
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    SB3 (proposed trastuzumab biosimilar)
    Reporting group description
    		 SB3 was administered in SB3-G31-BC study (2013-004172-35). No additional IP was administered for this study since it was an observational study.

    Reporting group title
    Herceptin
    Reporting group description
    		 Herceptin was administered in SB3-G31-BC study (2013-004172-35). No additional IP was administered for this study since it was an observational study.

    Subject analysis set title
    Survival Follow-up Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This set consisted of all subjects who enrolled for this study. This set included Cardiac Safety and Survival Cohort and Survival Only Cohort.

    Primary: The incidence of CHF and asymptomatic significant LVEF decrease

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    End point title
    		 The incidence of CHF and asymptomatic significant LVEF decrease [1]
    End point description
    End point type
    Primary
    End point timeframe
    during overall study period
    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: This is primarily designed to observe the incidence of symptomatic CHF, asymptomatic significant LVEF decrease, and other cardiac events in breast cancer patients treated with SB3 or Herceptin® according to the protocol SB3-G31-BC. There is no pre-defined hypothesis testing, therefore all analyses will be performed for the observational or exploratory purpose.
    End point values
    		 SB3 (proposed trastuzumab biosimilar) Herceptin Survival Follow-up Set
    Number of subjects analysed
    186 [2]
    181 [3]
    367 [4]
    Units: no.
    1
    2
    3
    Notes
    [2] - Long-term follow-up set
    [3] - Long-term follow-up set
    [4] - Long-term follow-up set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Since SB3-G31-BC-E study was to assess the long-term cardiac safety for SB3 or Herceptin®, which was mainly about post-dose cardiac toxicities captured through cardiac assessments, non-serious AEs were not intended to be collected through this study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 N/A
    Dictionary version
    N/A
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Since SB3-G31-BC-E study was to assess the long-term cardiac safety for SB3 or Herceptin®, which was mainly about post-dose cardiac toxicities captured through cardiac assessments and not by AE reporting, other non-serious AEs were not intended to be collected through this study. However, for any type of serious AE (SAE; cardiac or non-cardiac) that could be determined by the Investigator to be related to the IP then that SAE was reported through a separate paper SAE report form to the Sponsor.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Nov 2018
    clarification on study design and eligibility criteria

    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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    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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