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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Study Description
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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

Condition or disease Intervention/treatment
Breast Neoplasms Drug: Herceptin (trastuzumab) Drug: SB3 (proposed trastuzumab biosimilar)

Study Design
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Study Type : Observational
Actual Enrollment : 549 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Herceptin (trastuzumab)
Intravenous administration
 Drug: Herceptin (trastuzumab)
Intravenous administration
Other Name: Herceptin
SB3 (proposed trastuzumab biosimilar)
Intravenous administration
 Drug: SB3 (proposed trastuzumab biosimilar)
Intravenous administration


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT02771795    
Other Study ID Numbers: SB3-G31-BC-E
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Keywords provided by Samsung Bioepis Co., Ltd.:
HER2
Trastuzumab
Biosimilar
 Cancer
Breast
Positive
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents