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Herceptin (trastuzumab)

DRUG4 trials

Sponsors

M.D. Anderson Cancer Center, Nantes University Hospital, Samsung Bioepis Co., Ltd., Tanvex BioPharma USA, Inc.

Conditions

Breast CancerBreast NeoplasmsDuctal Carcinoma In SituEarly-stage Breast CancerHER2-positive Breast CancerRelapsed/Refractory LeukemiaStage II Breast CancerStage IIIA Breast Cancer

Phase 2

Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)
TerminatedNCT00724360
Nantes University HospitalRelapsed/Refractory Leukemia
Start: 2006-11-30End: 2011-11-30Updated: 2013-10-07

Phase 3

Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
CompletedNCT04109391
Tanvex BioPharma USA, Inc.Breast Cancer, Breast Neoplasms, Early-stage Breast Cancer +3
Start: 2019-08-20End: 2022-03-08Updated: 2022-10-26

Unknown Phase

Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
CompletedNCT00496808
M.D. Anderson Cancer CenterDuctal Carcinoma In Situ
Start: 2005-03-31End: 2010-11-30Updated: 2020-09-23
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
TX05-03e: Adjuvant treatment following neoadjuvant treatment and surgical resection in TX05-03, a trial comparing the safety, efficacy, and immunogenicity of trastuzumab biosimilar candidate (TX05) with originator trastuzumab in HER2+ EBC.
Journal of Clinical Oncology2022-06-08
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