A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
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|ClinicalTrials.gov Identifier: NCT02771795|
Recruitment Status : Terminated (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.)
First Posted : May 13, 2016
Last Update Posted : January 7, 2021
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|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Drug: Herceptin (trastuzumab) Drug: SB3 (proposed trastuzumab biosimilar)|
|Study Type :||Observational|
|Actual Enrollment :||549 participants|
|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|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||December 2020|
|Actual Study Completion Date :||December 2020|
Drug: Herceptin (trastuzumab)
Other Name: Herceptin
SB3 (proposed trastuzumab biosimilar)
Drug: SB3 (proposed trastuzumab biosimilar)
- The incidence of congestive heart failure and LVEF decrease [ Time Frame: 60 months ]Incidence of symptomatic congestive heart failure (CHF) NYHA class II, III, and IV and asymptomatic significant LVEF decrease
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- Subjects who received the study treatment of SB3-G31-BC.
- Subjects who provide informed consent.
- Subjects unwilling to follow the study requirements are not eligible for the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771795
|Responsible Party:||Samsung Bioepis Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||May 13, 2016 Key Record Dates|
|Last Update Posted:||January 7, 2021|
|Last Verified:||January 2021|
Neoplasms by Site
Antineoplastic Agents, Immunological