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

January 31, 2024 updated by: Samsung Bioepis Co., Ltd.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

538

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Vratsa, Bulgaria, 3000
        • Complex Oncological Center - Vratsa, EOOD
  • Czechia
      • Praha, Czechia, 14000
        • ONKOCENTRUM Medicon Services s.r.o.
  • France
      • Besançon, France, 25030
        • CHU Besançon - Hôpital Jean Minjoz
      • Montbéliard, France, 25209
        • Centre Hospitalier de Belfort-Montbéliard
  • Poland
      • Bialystok, Poland, 15 027
        • Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie w Bialymstoku
      • Bydgoszcz, Poland, 85 796
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
      • Gdansk, Poland, 80 952
        • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
      • Olsztyn, Poland, 10 228
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej
      • Opole, Poland, 45-060
        • Samodzielny Publiczny ZOZ Opolskiego Centrum Onkologii w Opolu im. T. Koszarowskiego
      • Poznań, Poland, 61 866
        • Wielkopolskie Centrum Onkologii, im Marii Sklodowskiej-Curie
      • Warsaw, Poland, 02 781
        • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
      • Warszawa, Poland, 03-984
        • MAGODENT Sp. z o.o.
  • Romania
      • Baia Mare, Romania, 430031
        • Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
      • Bucuresti, Romania, 013811
        • SC Centrul Medical Unirea SRL-Policlinica Baneasa, Specialitatea Oncologie Medicala
      • Bucuresti, Romania, 11171
        • Spitalul Clinic Filantropia, Compartimentul Oncologie Ginecologica
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
      • Cluj-Napoca, Romania, 400349
        • Spitalul Clinic Judetean de Urgenta Cluj Napoca
      • Ploiesti, Romania, 100337
        • Spitalul Municipal Ploiesti, Sectia Oncologie Medicala
      • Timisoara, Romania, 300239
        • S.C Oncomed S.R.L
      • Timisoara, Romania, 300595
        • Spitalul Clinic Municipal de Urgenta Timisoara
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • S.I. Russian Oncological Research Center n.a. N.N. Blokhin
      • Moscow, Russian Federation, 125284
        • Federal State Budgetary Institution "Federal Medical Research Center n.a. P.A Gertsen" of Ministry of healthcare of RF/3
      • Ryazan, Russian Federation, 390026
        • SBI of Ryazan region "Regional Clinical Oncological Dispensary"
      • Saint Petersburg, Russian Federation, 195271
        • Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways"
      • Saint Petersburg, Russian Federation, 197022
        • Saint-Petersburg SBHI "City Clinical Oncology Dispensary"
      • Saint-Petersburg, Russian Federation, 191014
        • SBHI "Leningrad Regional Oncology Dispensary"
      • Saint-Petersburg, Russian Federation, 197758
        • FSI "Scientific and Research Institution of Oncology n.a. N.N.Petrov" of Ministry of Healthcare and SD of RF
      • Saint-Petersburg, Russian Federation, 197758
        • SBHI "Saint-Petersburg Scientific and Practical Center of Specialized Methods of Medical Help (oncological)
      • Yaroslavl, Russian Federation, 150054
        • SHBI of Yaroslavl Region "Regional Clinical Oncology Hospital"
      • Оmsk, Russian Federation, 644013
        • BHI of Omsk region "Clinical Oncology Dispensary"
    • Krasnogorsk District
      • Istra, Krasnogorsk District, Russian Federation, 143423
        • SBHI of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Department
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Communal Institution Cherkasy Regional Oncological Dispensary of Cherkasy Regional Council
      • Dnipropetrovsk, Ukraine, 49102
        • Communal Institution Dnipropetrovsk City Multifield Clinical Hospital No.4 of Dnipropetrovsk Regional Council
      • Kharkiv, Ukraine, 61070
        • Communal Non-commercial Enterprise Regional Center of Oncology
      • Kherson, Ukraine, 73000
        • Communal Institution of Kherson Regional Council Kherson Regional Oncological Dispensary
      • Lviv, Ukraine, 79031
        • Lviv State Oncological Regional Treatment and Diagnostic Center
      • Sumy, Ukraine, 40005
        • Regional Communal Institution Sumy Regional Clinical Oncological Dispensary
      • Uzhgorod, Ukraine, 88000
        • Uzhgorod Central City Clinical Hospital City Oncological Center
      • Vinnytsia, Ukraine, 21029
        • Vinnytsia Regional Clinical Oncological Dispensary
      • Zaporizhzhia, Ukraine, 69040
        • Communal Institution Zaporizhzhia Regional Clinical Oncological Dispensary of Zaporizhzhia Regional Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with HER2 positive early or locally advanced breast cancer who received SB3 or Herceptin according to clinical trial SB3-G31-BC.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Herceptin (trastuzumab)
Intravenous administration
Drug: Herceptin (trastuzumab)
Intravenous administration
Other Names:
  • Herceptin
SB3 (proposed trastuzumab biosimilar)
Intravenous administration
Drug: SB3 (proposed trastuzumab biosimilar)
Intravenous administration

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Bioepis Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimated)

May 13, 2016

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB3-G31-BC-E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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