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    Summary
    EudraCT Number:2015-005663-17
    Sponsor's Protocol Code Number:SB3-G31-BC-E
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-10-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-005663-17
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term Follow-up Study for Cardiac Safety in the Patients with Breast Cancer Who Have Completed the Main Study
    A.4.1Sponsor's protocol code numberSB3-G31-BC-E
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSamsung Bioepis Co., Ltd.
    B.1.3.4CountryKorea, Republic of
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSamsung Bioepis Co.,Ltd.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIQVIA Limited
    B.5.2Functional name of contact pointIQVIA Contact Centre
    B.5.3 Address:
    B.5.3.1Street AddressThe Alba Campus, Rosebank
    B.5.3.2Town/ cityLivingston
    B.5.3.3Post codeEH54 7EG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0018622613634
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP Role
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ontruzant
    D.2.1.1.2Name of the Marketing Authorisation holderSamsung Bioepis NL B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSB3 ( Trastuzumab biosimilar)
    D.3.2Product code SB3
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with primary HER2 positive early or locally advanced breast cancer, who received the IP (SB3 or Herceptin®) in the SB3-G31-BC
    trial.
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10065430
    E.1.2Term HER-2 positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10072740
    E.1.2Term Locally advanced breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to observe the incidence of symptomatic congestive heart failure (CHF) New York Heart Association (NYHA) class II,III and IV and asymptomatic left ventricular ejection fraction (LVEF) decrease in subjects who participated in the SB3-G31-BC trial and treated with SB3 ( proposed trastuzumab biosimilar) or Herceptin® as neoadjuvant and adjuvant treatment.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    To observe the incidence of cardiac death and other significant cardiac
    conditions
    To observe the long term efficacy of SB3 compared to Herceptin® by
    •Event-free survival (EFS) and disease-free survival (DFS)
    •Overall Survival (OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [Cardiac Safety and Survival Cohort]
    Subjects must meet all of the following criteria to be eligible for the study:
    1.Subjects who have completed the study treatment of SB3-G31-BC trial according to the protocol.
    2.Subjects must provide informed consent.
    [Survival Only Cohort]
    Inclusion criteria
    Subjects must meet all of the following criteria to be eligible for the study:
    1. Subjects who received SB3 or Herceptin® according to the clinical trial SB3-G31-BC.
    2. Subjects who provide informed consent. If prospective data collection is not possible (e.g. when the subject is deceased or lost to follow-up), a
    waiver of informed consent/authorization will be requested for the retrospective data collection from medical records, where applicable and
    in accordance with national regulations and local ethics. If ICF waiver for the deceased subject is not allowed, their next-of-kin (if applicable)
    will be informed accordingly, and will be asked to give their consent where applicable and approved by IRB/IEC and in accordance with national regulations.
    E.4Principal exclusion criteria
    [Cardiac Safety and Survival Cohort]:
    Subjects unwilling to follow the study requirements are not eligible for the study.

    [Survival Only Cohort]:
    There is no exclusion criteria for the Survival Only Cohort.
    E.5 End points
    E.5.1Primary end point(s)
    The incidence of symptomatic CHF and asymptomatic significant LVEF decrease
    -CHF, defined as NYHA II, III, IV, confirmed by a cardiologist, accompanied by a significant LVEF decrease.
    -Significant LVEF decrease, defined as an absolute decline of at least 10 % points from baseline LVEF (LVEF at screening of the SB3-G31-BC trial)
    and resulting LVEF less than 50%
    E.5.1.1Timepoint(s) of evaluation of this end point
    All analysis will be performed periodically and at the end of the study
    E.5.2Secondary end point(s)
    1. The incidence of cardiac death and other significant cardiac conditions
    -Cardiac death, defined as death definitely as a result of heart failure, myocardial infarction, or documented arrhythmia or as probable cardiac
    death within 24 hours of a cardiac event.
    2. EFS defined as the time from the date of randomisation for the SB3-G31- BC trial to the date where an event occurs. An event is breast cancer recurrence or progression (local, regional, distant or contralateral) or death due to any cause.
    3. DFS, defined as the time from the date of surgery for the SB3-G31-BC trial to the date where an event occurs. An event is breast cancer recurrence (local, regional, distant, or contralateral) or death due to any cause.
    4. OS, defined as the time from the date of randomisation for the SB3-G31-BC trial to the date of death, regardless of the cause of death.
    Subjects who were alive at the time of analysis will be censored at the date of the last follow up assessment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All analysis will be performed periodically and at the end of the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Follow up study - NO IMP will be administered
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bosnia and Herzegovina
    India
    Korea, Republic of
    Malaysia
    Philippines
    Russian Federation
    Ukraine
    Vietnam
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    5 years after last patient has been enrolled
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 555
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 57
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-10-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state143
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 186
    F.4.2.2In the whole clinical trial 612
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No IMP will be administered in this study. Subjects will continue on their normal care during and after the study
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-12-11
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