Study Stopped
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.
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
1 other identifier
observational
538
7 countries
40
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 9, 2016
CompletedFirst Posted
Study publicly available on registry
May 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedResults Posted
Study results publicly available
February 2, 2024
CompletedFebruary 2, 2024
January 1, 2024
4.7 years
May 9, 2016
June 14, 2022
January 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Herceptin (trastuzumab)
Intravenous administration
SB3 (proposed trastuzumab biosimilar)
Intravenous administration
Interventions
Intravenous administration
Intravenous administration
Eligibility Criteria
Patients with HER2 positive early or locally advanced breast cancer who received SB3 or Herceptin according to clinical trial SB3-G31-BC.
You may qualify if:
- Subjects who received the study treatment of SB3-G31-BC.
- Subjects who provide informed consent.
You may not qualify if:
- Subjects unwilling to follow the study requirements are not eligible for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Complex Oncological Center - Vratsa, EOOD
Vratsa, 3000, Bulgaria
ONKOCENTRUM Medicon Services s.r.o.
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
Ploieşti, 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 №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
Related Publications (2)
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: 37022687DERIVEDPivot 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.
PMID: 31445454DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Samsung Bioepis Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2016
First Posted
May 13, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
February 2, 2024
Results First Posted
February 2, 2024
Record last verified: 2024-01