Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Antineoplastic Agents, Immunological

Herceptin (trastuzumab)

SB3 (proposed trastuzumab biosimilar)

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

A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC

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

Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF \< 50%

Samsung Bioepis Co., Ltd.

For any type of serious AE (SAE; cardiac or non-cardiac) that could be determined by the Investigator to be related to the IP then that SAE was reported through a separate paper SAE report form to the Sponsor.

Intravenous administration Herceptin (trastuzumab): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.

Herceptin (Trastuzumab)

Intravenous administration SB3 (proposed trastuzumab biosimilar): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.

SB3 (Proposed Trastuzumab Biosimilar)

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Director of Clinical Trials

Intravenous administration

Herceptin (trastuzumab): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.

Intravenous administration

SB3 (proposed trastuzumab biosimilar): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.

Number of Subjects With Asymptomatic Significant LVEF Decrease

Overall Study

Herceptin (trastuzuamb)

Xavier Pivot

A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin® in Women with Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting

A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer

A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB3 (Proposed Trastuzumab Biosimilar) and Herceptin® in Women With Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting

Intravenous administration

Herceptin (trastuzuamb): Intravenous administration

Intravenous administration

SB3 (proposed trastuzumab biosimilar): Intravenous administration

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC	NCT02771795	Breast Neoplasm...	Herceptin (tras... SB3 (proposed t...	18 Years -	Samsung Bioepis Co., Ltd.
A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer	NCT02149524	HER2 Positive E...	Herceptin (tras... SB3 (proposed t...	18 Years - 65 Years	Samsung Bioepis Co., Ltd.
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC	NCT02771795	Breast Neoplasm...	Herceptin (tras... SB3 (proposed t...	18 Years -	Samsung Bioepis Co., Ltd.

Spots Global Cancer Trial Database for sb3 (proposed trastuzumab biosimilar)