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)

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

ONKOCENTRUM Medicon Services s.r.o.; 🇨🇿 Praha, 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; 🇵🇱 Poznań, Poland

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