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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.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Herceptin (trastuzumab) | Intravenous administration |
| |
| SB3 (proposed trastuzumab biosimilar) | Intravenous administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herceptin (trastuzumab) | Drug | Intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Asymptomatic Significant LVEF Decrease | Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF < 50% | approximately 56 months (median follow-up duration) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with HER2 positive early or locally advanced breast cancer who received SB3 or Herceptin according to clinical trial SB3-G31-BC.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complex Oncological Center - Vratsa, EOOD | Vratsa | 3000 | Bulgaria | |||
| ONKOCENTRUM Medicon Services s.r.o. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37022687 | Derived | 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. | |
| 31445454 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Herceptin (Trastuzumab) | 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. |
| FG001 | SB3 (Proposed Trastuzumab Biosimilar) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2021 |
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| SB3 (proposed trastuzumab biosimilar) | Drug | Intravenous administration |
|
| Prague |
| 14000 |
| Czechia |
| CHU Besançon - Hôpital Jean Minjoz | Besançon | 25030 | France |
| Centre Hospitalier de Belfort-Montbeliard | Montbéliard | 25209 | France |
| Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie w Bialymstoku | Bialystok | 15 027 | Poland |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy | Bydgoszcz | 85 796 | Poland |
| Uniwersyteckie Centrum Kliniczne, Klinika Onkologii I Radioterapii | Gdansk | 80 952 | Poland |
| Samodzielny Publiczny Zakład Opieki Zdrowotnej | Olsztyn | 10 228 | Poland |
| Samodzielny Publiczny ZOZ Opolskiego Centrum Onkologii w Opolu im. T. Koszarowskiego | Opole | 45-060 | Poland |
| Wielkopolskie Centrum Onkologii, im Marii Sklodowskiej-Curie | Poznan | 61 866 | Poland |
| Centrum Onkologii-Instytut im. M. Sklodowskiej Curie | Warsaw | 02 781 | Poland |
| Magodent Sp. Z o.o. | Warsaw | 03-984 | Poland |
| Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare | Baia Mare | 430031 | Romania |
| SC Centrul Medical Unirea SRL-Policlinica Baneasa, Specialitatea Oncologie Medicala | Bucharest | 013811 | Romania |
| Spitalul Clinic Filantropia, Compartimentul Oncologie Ginecologica | Bucharest | 11171 | Romania |
| Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca | Cluj-Napoca | 400015 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj Napoca | Cluj-Napoca | 400349 | Romania |
| Spitalul Municipal Ploiesti, Sectia Oncologie Medicala | PloieÅŸti | 100337 | Romania |
| S.C Oncomed S.R.L | Timișoara | 300239 | Romania |
| Spitalul Clinic Municipal de Urgenta Timisoara | Timișoara | 300595 | Romania |
| SBHI of Moscow City "Moscow City Oncology Hospital â„–62" of Moscow Healthcare Department | Istra | Krasnogorsk District | 143423 | Russia |
| S.I. Russian Oncological Research Center n.a. N.N. Blokhin | Moscow | 115478 | Russia |
| Federal State Budgetary Institution "Federal Medical Research Center n.a. P.A Gertsen" of Ministry of healthcare of RF/3 | Moscow | 125284 | Russia |
| SBI of Ryazan region "Regional Clinical Oncological Dispensary" | Ryazan | 390026 | Russia |
| SBHI "Leningrad Regional Oncology Dispensary" | Saint Petersburg | 191014 | Russia |
| Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways" | Saint Petersburg | 195271 | Russia |
| Saint-Petersburg SBHI "City Clinical Oncology Dispensary" | Saint Petersburg | 197022 | Russia |
| FSI "Scientific and Research Institution of Oncology n.a. N.N.Petrov" of Ministry of Healthcare and SD of RF | Saint Petersburg | 197758 | Russia |
| SBHI "Saint-Petersburg Scientific and Practical Center of Specialized Methods of Medical Help (oncological) | Saint Petersburg | 197758 | Russia |
| SHBI of Yaroslavl Region "Regional Clinical Oncology Hospital" | Yaroslavl | 150054 | Russia |
| BHI of Omsk Region "Clinical Oncology Dispensary" | Оmsk | 644013 | Russia |
| Communal Institution Cherkasy Regional Oncological Dispensary of Cherkasy Regional Council | Cherkasy | 18009 | Ukraine |
| Communal Institution Dnipropetrovsk City Multifield Clinical Hospital No.4 of Dnipropetrovsk Regional Council | Dnipropetrovsk | 49102 | Ukraine |
| Communal Non-commercial Enterprise Regional Center of Oncology | Kharkiv | 61070 | Ukraine |
| Communal Institution of Kherson Regional Council Kherson Regional Oncological Dispensary | Kherson | 73000 | Ukraine |
| Lviv State Oncological Regional Treatment and Diagnostic Center | Lviv | 79031 | Ukraine |
| Regional Communal Institution Sumy Regional Clinical Oncological Dispensary | Sumy | 40005 | Ukraine |
| Uzhgorod Central City Clinical Hospital City Oncological Center | Uzhhorod | 88000 | Ukraine |
| Vinnytsia Regional Clinical Oncological Dispensary | Vinnytsia | 21029 | Ukraine |
| Communal Institution Zaporizhzhia Regional Clinical Oncological Dispensary of Zaporizhzhia Regional Council | Zaporizhzhia | 69040 | Ukraine |
| Derived |
| 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. |
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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Herceptin (Trastuzumab) | 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. |
| BG001 | SB3 (Proposed Trastuzumab Biosimilar) | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Asymptomatic Significant LVEF Decrease | Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF < 50% | Long-term follow-up set | Posted | Count of Participants | Participants | approximately 56 months (median follow-up duration) |
|
|
|
Through end of the study, approximately 4.7 years; 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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Herceptin (Trastuzumab) | 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. | 38 | 271 | 1 | 271 | 0 | 271 |
| EG001 | SB3 (Proposed Trastuzumab Biosimilar) | 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. | 22 | 267 | 0 | 267 | 0 | 267 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac death | Cardiac disorders | Non-systematic Assessment |
|
Not provided
- At least sixty (60) dayas prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy of all such manuscripts and materials, and allow the Sponsor sixty (60) days to review and comment on them to ensure that the publication would not disclose any Confidential Information or impair the Sponsor's ability to obtain patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Samsung Bioepis Co., Ltd. | +82-32-728-0371 | sbregistry@samsung.com |
| Jun 14, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|