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Trial record 2 of 8 for:    SB3

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 : Active, not recruiting
First Posted : May 13, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Herceptin (trastuzumab) Drug: SB3 (proposed trastuzumab biosimilar) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 367 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Active Comparator: Herceptin (trastuzumab)
Intravenous administration
Drug: Herceptin (trastuzumab)
Intravenous administration
Other Name: Herceptin

Experimental: SB3 (proposed trastuzumab biosimilar)
Intravenous administration
Drug: SB3 (proposed trastuzumab biosimilar)
Intravenous administration




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



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
Criteria

Inclusion Criteria:

  • Subjects have completed the study treatment of SB3-G31-BC.
  • Subjects must provide informed consent.

Exclusion Criteria:

  • Subjects unwilling to follow the study requirements are not eligible for the study.

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


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Sponsors and Collaborators
Samsung Bioepis Co., Ltd.

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Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT02771795     History of Changes
Other Study ID Numbers: SB3-G31-BC-E
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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