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

> **NCT02771795** · — · TERMINATED · sponsor: **Samsung Bioepis Co., Ltd.** · enrollment: 538 (actual)

## Conditions studied

- Breast Neoplasms

## Interventions

- **DRUG:** Herceptin (trastuzumab)
- **DRUG:** SB3 (proposed trastuzumab biosimilar)

## Key facts

- **NCT ID:** NCT02771795
- **Lead sponsor:** Samsung Bioepis Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** TERMINATED
- **Start date:** 2016-04
- **Primary completion:** 2020-12
- **Final completion:** 2020-12
- **Target enrollment:** 538 (ACTUAL)
- **Why stopped:** 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.
- **Last updated:** 2024-02-02


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02771795

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02771795, "A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT02771795. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*