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

N/ATerminatedNCT02771795
Samsung Bioepis Co., Ltd.538 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

538

Conditions

Breast Neoplasms

Interventions

Herceptin (trastuzumab)DRUG

Intravenous administration

SB3 (proposed trastuzumab biosimilar)DRUG

Intravenous administration

Eligibility

Sex: FEMALEMin age: 18 Years
Medical Language ↔ Plain English
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.

Locations (40)

Complex Oncological Center - Vratsa, EOOD

Vratsa, Bulgaria

ONKOCENTRUM Medicon Services s.r.o.

Prague, Czechia

CHU Besançon - Hôpital Jean Minjoz

Besançon, France

Centre Hospitalier de Belfort-Montbeliard

Montbéliard, France

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 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

Poznan, Poland

...and 30 more locations

Outcomes

Primary Outcomes

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%

Time frame: approximately 56 months (median follow-up duration)

Data from ClinicalTrials.gov

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