A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
NCT ID: NCT02771795
Last Updated: 2024-02-02
Study Results
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View full resultsBasic Information
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TERMINATED
538 participants
OBSERVATIONAL
2016-04-30
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Herceptin (trastuzumab)
Intravenous administration
Herceptin (trastuzumab)
Intravenous administration
SB3 (proposed trastuzumab biosimilar)
Intravenous administration
SB3 (proposed trastuzumab biosimilar)
Intravenous administration
Interventions
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Herceptin (trastuzumab)
Intravenous administration
SB3 (proposed trastuzumab biosimilar)
Intravenous administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who provide informed consent.
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Samsung Bioepis Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Complex Oncological Center - Vratsa, EOOD
Vratsa, , Bulgaria
ONKOCENTRUM Medicon Services s.r.o.
Prague, , Czechia
CHU Besançon - Hôpital Jean Minjoz
Besançon, , France
Centre Hospitalier de Belfort-Montbeliard
Montbéliard, , France
Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie w Bialymstoku
Bialystok, , Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii I Radioterapii
Gdansk, , Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej
Olsztyn, , Poland
Samodzielny Publiczny ZOZ Opolskiego Centrum Onkologii w Opolu im. T. Koszarowskiego
Opole, , Poland
Wielkopolskie Centrum Onkologii, im Marii Sklodowskiej-Curie
Poznan, , Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, , Poland
Magodent Sp. Z o.o.
Warsaw, , Poland
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
Baia Mare, , Romania
SC Centrul Medical Unirea SRL-Policlinica Baneasa, Specialitatea Oncologie Medicala
Bucharest, , Romania
Spitalul Clinic Filantropia, Compartimentul Oncologie Ginecologica
Bucharest, , Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Cluj-Napoca, , Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, , Romania
Spitalul Municipal Ploiesti, Sectia Oncologie Medicala
Ploieşti, , Romania
S.C Oncomed S.R.L
Timișoara, , Romania
Spitalul Clinic Municipal de Urgenta Timisoara
Timișoara, , Romania
SBHI of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Department
Istra, Krasnogorsk District, Russia
S.I. Russian Oncological Research Center n.a. N.N. Blokhin
Moscow, , Russia
Federal State Budgetary Institution "Federal Medical Research Center n.a. P.A Gertsen" of Ministry of healthcare of RF/3
Moscow, , Russia
SBI of Ryazan region "Regional Clinical Oncological Dispensary"
Ryazan, , Russia
SBHI "Leningrad Regional Oncology Dispensary"
Saint Petersburg, , Russia
Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways"
Saint Petersburg, , Russia
Saint-Petersburg SBHI "City Clinical Oncology Dispensary"
Saint Petersburg, , Russia
FSI "Scientific and Research Institution of Oncology n.a. N.N.Petrov" of Ministry of Healthcare and SD of RF
Saint Petersburg, , Russia
SBHI "Saint-Petersburg Scientific and Practical Center of Specialized Methods of Medical Help (oncological)
Saint Petersburg, , Russia
SHBI of Yaroslavl Region "Regional Clinical Oncology Hospital"
Yaroslavl, , Russia
BHI of Omsk Region "Clinical Oncology Dispensary"
Оmsk, , Russia
Communal Institution Cherkasy Regional Oncological Dispensary of Cherkasy Regional Council
Cherkasy, , Ukraine
Communal Institution Dnipropetrovsk City Multifield Clinical Hospital No.4 of Dnipropetrovsk Regional Council
Dnipropetrovsk, , Ukraine
Communal Non-commercial Enterprise Regional Center of Oncology
Kharkiv, , Ukraine
Communal Institution of Kherson Regional Council Kherson Regional Oncological Dispensary
Kherson, , Ukraine
Lviv State Oncological Regional Treatment and Diagnostic Center
Lviv, , Ukraine
Regional Communal Institution Sumy Regional Clinical Oncological Dispensary
Sumy, , Ukraine
Uzhgorod Central City Clinical Hospital City Oncological Center
Uzhhorod, , Ukraine
Vinnytsia Regional Clinical Oncological Dispensary
Vinnytsia, , Ukraine
Communal Institution Zaporizhzhia Regional Clinical Oncological Dispensary of Zaporizhzhia Regional Council
Zaporizhzhia, , Ukraine
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SB3-G31-BC-E
Identifier Type: -
Identifier Source: org_study_id
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