A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC

Terminated

• Conditions: Breast Neoplasms
• Interventions: Drug: Herceptin (trastuzumab); Drug: SB3 (proposed trastuzumab biosimilar)

• Registration Number: NCT02771795
• Lead Sponsor: Samsung Bioepis Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-13
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Results First Submitted: 2022-06-14
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Results First Posted: 2024-02-02
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 538

Inclusion Criteria

• Subjects who received the study treatment of SB3-G31-BC.
• Subjects who provide informed consent.

Exclusion Criteria

• Subjects unwilling to follow the study requirements are not eligible for the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Herceptin (trastuzumab)	Herceptin (trastuzumab)	Intravenous administration
SB3 (proposed trastuzumab biosimilar)	SB3 (proposed trastuzumab biosimilar)	Intravenous administration

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Asymptomatic Significant LVEF Decrease	approximately 56 months (median follow-up duration)	Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF \< 50%

Trial Locations

Locations (40)

BHI of Omsk Region "Clinical Oncology Dispensary"; 🇷🇺 Оmsk, Russian Federation

Complex Oncological Center - Vratsa, EOOD; 🇧🇬 Vratsa, Bulgaria

CHU Besançon - Hôpital Jean Minjoz; 🇫🇷 Besançon, France

Centre Hospitalier de Belfort-Montbeliard; 🇫🇷 Montbéliard, France

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii I Radioterapii; 🇵🇱 Gdansk, Poland

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie; 🇵🇱 Warsaw, Poland

Magodent Sp. Z o.o.; 🇵🇱 Warszawa, Poland

Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare; 🇷🇴 Baia Mare, Romania

Saint-Petersburg SBHI "City Clinical Oncology Dispensary"; 🇷🇺 Saint Petersburg, Russian Federation

ONKOCENTRUM Medicon Services s.r.o.; 🇨🇿 Praha, Czechia

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; 🇵🇱 Poznań, Poland

Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy; 🇵🇱 Bydgoszcz, Poland

SC Centrul Medical Unirea SRL-Policlinica Baneasa, Specialitatea Oncologie Medicala; 🇷🇴 Bucuresti, Romania

Spitalul Clinic Filantropia, Compartimentul Oncologie Ginecologica; 🇷🇴 Bucuresti, Romania

Spitalul Clinic Municipal de Urgenta Timisoara; 🇷🇴 Timisoara, Romania

Federal State Budgetary Institution "Federal Medical Research Center n.a. P.A Gertsen" of Ministry of healthcare of RF/3; 🇷🇺 Moscow, Russian Federation

SHBI of Yaroslavl Region "Regional Clinical Oncology Hospital"; 🇷🇺 Yaroslavl, Russian Federation

Lviv State Oncological Regional Treatment and Diagnostic Center; 🇺🇦 Lviv, Ukraine

Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie w Bialymstoku; 🇵🇱 Bialystok, Poland

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; 🇷🇴 Ploiesti, Romania

S.C Oncomed S.R.L; 🇷🇴 Timisoara, Romania

SBHI of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Department; 🇷🇺 Istra, Krasnogorsk District, Russian Federation

SBI of Ryazan region "Regional Clinical Oncological Dispensary"; 🇷🇺 Ryazan, Russian Federation

Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways"; 🇷🇺 Saint Petersburg, Russian Federation

SBHI "Leningrad Regional Oncology Dispensary"; 🇷🇺 Saint-Petersburg, Russian Federation

FSI "Scientific and Research Institution of Oncology n.a. N.N.Petrov" of Ministry of Healthcare and SD of RF; 🇷🇺 Saint-Petersburg, Russian Federation

SBHI "Saint-Petersburg Scientific and Practical Center of Specialized Methods of Medical Help (oncological); 🇷🇺 Saint-Petersburg, Russian Federation

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 Institution of Kherson Regional Council Kherson Regional Oncological Dispensary; 🇺🇦 Kherson, Ukraine

S.I. Russian Oncological Research Center n.a. N.N. Blokhin; 🇷🇺 Moscow, Russian Federation

Communal Non-commercial Enterprise Regional Center of Oncology; 🇺🇦 Kharkiv, Ukraine

Regional Communal Institution Sumy Regional Clinical Oncological Dispensary; 🇺🇦 Sumy, Ukraine

Uzhgorod Central City Clinical Hospital City Oncological Center; 🇺🇦 Uzhgorod, Ukraine

Vinnytsia Regional Clinical Oncological Dispensary; 🇺🇦 Vinnytsia, Ukraine

Communal Institution Zaporizhzhia Regional Clinical Oncological Dispensary of Zaporizhzhia Regional Council; 🇺🇦 Zaporizhzhia, Ukraine