ong-term Follow-up Study for Cardiac Safety in the Patients with Breast Cancer Who Have Completed the Main Study

Phase 1

• Conditions: Subjects with primary HER2 positive early or locally advanced breast cancer, who received the IP (SB3 or Herceptin®) in the SB3-G31-BCtrial.; MedDRA version: 21.1Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005663-17-PL
• Lead Sponsor: Samsung Bioepis Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-24
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 612

Inclusion Criteria

[Cardiac Safety and Survival Cohort]
Subjects must meet all of the following criteria to be eligible for the study:
1.Subjects who have completed the study treatment of SB3-G31-BC trial according to the protocol.
2.Subjects must provide informed consent.
[Survival Only Cohort]
Inclusion criteria
Subjects must meet all of the following criteria to be eligible for the study:
1. Subjects who received SB3 or Herceptin® according to the clinical trial SB3-G31-BC.
2. Subjects who provide informed consent. If prospective data collection is not possible (e.g. when the subject is deceased or lost to follow-up), a
waiver of informed consent/authorization will be requested for the retrospective data collection from medical records, where applicable and
in accordance with national regulations and local ethics. If ICF waiver for the deceased subject is not allowed, their next-of-kin (if applicable)
will be informed accordingly, and will be asked to give their consent where applicable and approved by IRB/IEC and in accordance with national regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 555
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57

Exclusion Criteria

[Cardiac Safety and Survival Cohort]:
Subjects unwilling to follow the study requirements are not eligible for the study.

[Survival Only Cohort]:
There is no exclusion criteria for the Survival Only Cohort.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified