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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02771795
• Other study ID #: SB3-G31-BC-E
• Status: Terminated
• Start date: April 2016
• Est. completion date: December 2020

Study information

• Verified date: January 2024
• Source: Samsung Bioepis Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 538
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Herceptin (trastuzumab)
Intravenous administration
• SB3 (proposed trastuzumab biosimilar)
Intravenous administration

Locations

Country	Name	City	State
Bulgaria	Complex Oncological Center - Vratsa, EOOD	Vratsa
Czechia	ONKOCENTRUM Medicon Services s.r.o.	Praha
France	CHU Besançon - Hôpital Jean Minjoz	Besançon
France	Centre Hospitalier de Belfort-Montbeliard	Montbéliard
Poland	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 Zaklad 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.	Warszawa
Romania	Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare	Baia Mare
Romania	SC Centrul Medical Unirea SRL-Policlinica Baneasa, Specialitatea Oncologie Medicala	Bucuresti
Romania	Spitalul Clinic Filantropia, Compartimentul Oncologie Ginecologica	Bucuresti
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	Ploiesti
Romania	S.C Oncomed S.R.L	Timisoara
Romania	Spitalul Clinic Municipal de Urgenta Timisoara	Timisoara
Russian Federation	BHI of Omsk Region "Clinical Oncology Dispensary"	?msk
Russian Federation	SBHI of Moscow City "Moscow City Oncology Hospital ?62" of Moscow Healthcare Department	Istra	Krasnogorsk District
Russian Federation	Federal State Budgetary Institution "Federal Medical Research Center n.a. P.A Gertsen" of Ministry of healthcare of RF/3	Moscow
Russian Federation	S.I. Russian Oncological Research Center n.a. N.N. Blokhin	Moscow
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	Saint-Petersburg SBHI "City Clinical 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 "Leningrad Regional Oncology Dispensary"	Saint-Petersburg
Russian Federation	SBHI "Saint-Petersburg Scientific and Practical Center of Specialized Methods of Medical Help (oncological)	Saint-Petersburg
Russian Federation	SHBI of Yaroslavl Region "Regional Clinical Oncology Hospital"	Yaroslavl
Ukraine	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	Uzhgorod
Ukraine	Vinnytsia Regional Clinical Oncological Dispensary	Vinnytsia
Ukraine	Communal Institution Zaporizhzhia Regional Clinical Oncological Dispensary of Zaporizhzhia Regional Council	Zaporizhzhia

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Bioepis Co., Ltd.

Countries where clinical trial is conducted

Bulgaria,  Czechia,  France,  Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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%	approximately 56 months (median follow-up duration)