Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-02-02 @ 12:18 AM
Study NCT ID:
NCT02771795
Status:
TERMINATED
Last Update Posted:
2024-02-02
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
Sponsor:
Organization:
Raw JSON
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No additional IP was administered for this study since it was an observational study.', 'otherNumAtRisk': 271, 'deathsNumAtRisk': 271, 'otherNumAffected': 0, 'seriousNumAtRisk': 271, 'deathsNumAffected': 38, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'SB3 (Proposed Trastuzumab Biosimilar)', 'description': 'Intravenous administration SB3 (proposed trastuzumab biosimilar): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.', 'otherNumAtRisk': 267, 'deathsNumAtRisk': 267, 'otherNumAffected': 0, 'seriousNumAtRisk': 267, 'deathsNumAffected': 22, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Asymptomatic Significant LVEF Decrease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin (Trastuzumab)', 'description': 'Intravenous administration\n\nHerceptin (trastuzumab): Intravenous administration in SB3-G31-BC study (NCT02149524). 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No additional IP was administered for this study since it was an observational study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approximately 56 months (median follow-up duration)', 'description': 'Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF \\< 50%', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Long-term follow-up set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Herceptin (Trastuzumab)', 'description': 'Intravenous administration\n\nHerceptin (trastuzumab): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.'}, {'id': 'FG001', 'title': 'SB3 (Proposed Trastuzumab Biosimilar)', 'description': 'Intravenous administration\n\nSB3 (proposed trastuzumab biosimilar): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '271'}, {'groupId': 'FG001', 'numSubjects': '267'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '222'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'Termination by premature discontinuation of study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '185'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Herceptin (Trastuzumab)', 'description': 'Intravenous administration Herceptin (trastuzumab): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.'}, {'id': 'BG001', 'title': 'SB3 (Proposed Trastuzumab Biosimilar)', 'description': 'Intravenous administration SB3 (proposed trastuzumab biosimilar): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '536', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-26', 'size': 4059582, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-14T01:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 538}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Considering the life-threatening risk posed by COVID-19 disease to a fragile population, the Sponsor concluded that the benefit of continuing the study does not outweigh the risk to the safety of patients \\& site staffs.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2016-05-09', 'resultsFirstSubmitDate': '2022-06-14', 'studyFirstSubmitQcDate': '2016-05-12', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-31', 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Asymptomatic Significant LVEF Decrease', 'timeFrame': 'approximately 56 months (median follow-up duration)', 'description': 'Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF \\< 50%'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HER2', 'Trastuzumab', 'Biosimilar', 'Cancer', 'Breast', 'Positive'], 'conditions': ['Breast Neoplasms']}, 'referencesModule': {'references': [{'pmid': '37022687', 'type': 'DERIVED', 'citation': 'Pivot X, Cortes J, Luftner D, Lyman GH, Curigliano G, Bondarenko IM, Ahn JH, Im SA, Litwiniuk M, Shparyk YV, Ho GF, Kislov NV, Wojtukiewicz M, Sarosiek T, Chae YS, Ahn JS, Jang H, Kim S, Lee J, Yoon Y. Cardiac Safety and Efficacy of SB3 Trastuzumab Biosimilar for ERBB2-Positive Early Breast Cancer: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e235822. doi: 10.1001/jamanetworkopen.2023.5822.'}, {'pmid': '31445454', 'type': 'DERIVED', 'citation': 'Pivot X, Pegram M, Cortes J, Luftner D, Lyman GH, Curigliano G, Bondarenko I, Yoon YC, Kim Y, Kim C. Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer. Eur J Cancer. 2019 Oct;120:1-9. doi: 10.1016/j.ejca.2019.07.015. Epub 2019 Aug 21.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with HER2 positive early or locally advanced breast cancer who received SB3 or Herceptin according to clinical trial SB3-G31-BC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who received the study treatment of SB3-G31-BC.\n* Subjects who provide informed consent.\n\nExclusion Criteria:\n\n* Subjects unwilling to follow the study requirements are not eligible for the study.'}, 'identificationModule': {'nctId': 'NCT02771795', 'briefTitle': 'A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Samsung Bioepis Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SB3-G31-BC-E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Herceptin (trastuzumab)', 'description': 'Intravenous administration', 'interventionNames': ['Drug: Herceptin (trastuzumab)']}, {'label': 'SB3 (proposed trastuzumab biosimilar)', 'description': 'Intravenous administration', 'interventionNames': ['Drug: SB3 (proposed trastuzumab biosimilar)']}], 'interventions': [{'name': 'Herceptin (trastuzumab)', 'type': 'DRUG', 'otherNames': ['Herceptin'], 'description': 'Intravenous administration', 'armGroupLabels': ['Herceptin (trastuzumab)']}, {'name': 'SB3 (proposed trastuzumab biosimilar)', 'type': 'DRUG', 'description': 'Intravenous administration', 'armGroupLabels': ['SB3 (proposed trastuzumab biosimilar)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Vratsa', 'country': 'Bulgaria', 'facility': 'Complex Oncological Center - Vratsa, EOOD', 'geoPoint': {'lat': 43.21052, 'lon': 23.56312}}, {'zip': '14000', 'city': 'Prague', 'country': 'Czechia', 'facility': 'ONKOCENTRUM Medicon Services s.r.o.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU Besançon - Hôpital Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '25209', 'city': 'Montbéliard', 'country': 'France', 'facility': 'Centre Hospitalier de Belfort-Montbeliard', 'geoPoint': {'lat': 47.50957, 'lon': 6.79823}}, {'zip': '15 027', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie w Bialymstoku', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '85 796', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Centrum Onkologii im. 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