Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT02771795
Status:
TERMINATED
Last Update Posted:
2024-02-02
First Post:
2016-05-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
Sponsor:
Samsung Bioepis Co., Ltd.
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Considering the life-threatening risk posed by COVID-19 disease to a fragile population, the Sponsor concluded that the benefit of continuing the study does not outweigh the risk to the safety of patients \& site staffs.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: