Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herceptin (trastuzumab) | Drug | Trastuzumab | ALIAS |
| SB3 (proposed trastuzumab biosimilar) | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Herceptin (trastuzumab)
- description
- Intravenous administration
- interventionNames
- Drug: Herceptin (trastuzumab)
- label
- SB3 (proposed trastuzumab biosimilar)
- description
- Intravenous administration
- interventionNames
- Drug: SB3 (proposed trastuzumab biosimilar)
Primary outcomes (1)
- measure
- Number of Subjects With Asymptomatic Significant LVEF Decrease
- timeFrame
- approximately 56 months (median follow-up duration)
- description
- Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF \< 50%
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDPivot X, Cortes J, Luftner D, Lyman GH, Curigliano G, Bondarenko IM, Ahn JH, Im SA, Litwiniuk M, Shparyk YV, Ho GF, Kislov NV, Wojtukiewicz M, Sarosiek T, Chae YS, Ahn JS, Jang H, Kim S, Lee J, Yoon Y. Cardiac Safety and Efficacy of SB3 Trastuzumab Biosimilar for ERBB2-Positive Early Breast Cancer: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e235822. doi: 10.1001/jamanetworkopen.2023.5822. PMID 37022687
- DERIVEDPivot X, Pegram M, Cortes J, Luftner D, Lyman GH, Curigliano G, Bondarenko I, Yoon YC, Kim Y, Kim C. Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer. Eur J Cancer. 2019 Oct;120:1-9. doi: 10.1016/j.ejca.2019.07.015. Epub 2019 Aug 21. PMID 31445454