SB3 (proposed trastuzumab biosimilar)

DRUG2 trials

Sponsors

Samsung Bioepis Co., Ltd.

Conditions

Breast NeoplasmsHER2 Positive Early or Locally Advanced Breast Cancer

Phase 3

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

CompletedNCT02149524

Samsung Bioepis Co., Ltd.HER2 Positive Early or Locally Advanced Breast Cancer

Start: 2014-04-30End: 2017-02-28Updated: 2018-10-24

Unknown Phase

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

TerminatedNCT02771795

Samsung Bioepis Co., Ltd.Breast Neoplasms

Start: 2016-04-30End: 2020-12-31Updated: 2024-02-02

Related Papers

Cardiac Safety and Efficacy of SB3 Trastuzumab Biosimilar for ERBB2-Positive Early Breast Cancer

JAMA Network Open2023-04-069 citations

Four-year follow-up of a phase III study comparing SB3 (trastuzumab biosimilar) and reference trastuzumab in HER2-positive early or locally advanced breast cancer in neoadjuvant setting.

Journal of Clinical Oncology2020-05-205 citations

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

European Journal of Cancer2019-08-2156 citations

Evaluation of survival by ADCC status: Subgroup analysis of SB3 (Trastuzumab Biosimilar) and reference trastuzumab in patients with HER2-positive early breast cancer at three-year follow-up.

Journal of Clinical Oncology2019-05-203 citations

Additional one-year follow-up study to evaluate safety and survival in patients who have completed neoadjuvant-adjuvant treatment with SB3 (trastuzumab biosimilar) or reference trastuzumab in HER2-positive early or locally advanced breast cancer.

Journal of Clinical Oncology2018-05-202 citations

A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results

European Journal of Cancer2018-02-1268 citations

Phase III, Randomized, Double-Blind Study Comparing the Efficacy, Safety, and Immunogenicity of SB3 (Trastuzumab Biosimilar) and Reference Trastuzumab in Patients Treated With Neoadjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer

Journal of Clinical Oncology2018-01-2695 citations

A randomized, double-blind, phase III study comparing SB3 (trastuzumab biosimilar) with originator trastuzumab in patients treated by neoadjuvant therapy for HER2-positive early breast cancer.

Journal of Clinical Oncology2017-05-2018 citations