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

Samsung

Status: Terminated

Conditions: Breast Neoplasms

Treatments: Drug: SB3 (proposed trastuzumab biosimilar); Drug: Herceptin (trastuzumab)

Study type: Observational

Funder types: Industry

Identifiers

NCT02771795

SB3-G31-BC-E

Details and patient eligibility

About

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

Enrollment: 538 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

538 participants in 2 patient groups

Herceptin (trastuzumab)

Description:

Intravenous administration

Treatment:

Drug: Herceptin (trastuzumab)

SB3 (proposed trastuzumab biosimilar)

Description:

Intravenous administration

Treatment:

Drug: SB3 (proposed trastuzumab biosimilar)