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Herceptin®

DRUG9 trials

Sponsors

Pfizer, Celgene, Shanghai Henlius Biotech, Tanvex BioPharma USA, Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Conditions

Breast CancerBreast NeoplasmsCarcinoma, BreastCarcinoma, Metastatic BreastHER2-positive Breast CancerHER2-positive Metastatic Breast CancerHealthyMetastatic Breast Cancer

Phase 1

Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
CompletedNCT00031278
PfizerCarcinoma, Metastatic Breast
Start: 2001-10-31End: 2003-06-30Updated: 2011-05-30
A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)
CompletedNCT02015156
PfizerHealthy
Start: 2014-01-31End: 2014-04-30Updated: 2014-04-23

Phase 2

CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer
CompletedNCT00043394
PfizerCarcinoma, Breast
Start: 2002-09-30End: 2003-10-31Updated: 2009-03-12
Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer
CompletedNCT00093145
CelgeneBreast Cancer
Start: 2004-06-01End: 2008-10-01Updated: 2019-11-25

Phase 3

A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)
CompletedNCT01989676
PfizerMetastatic Breast Cancer
Start: 2014-02-24End: 2020-06-27Updated: 2021-07-06
Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer
CompletedNCT03084237
Shanghai Henlius BiotechBreast Cancer
Start: 2016-11-30End: 2021-09-28Updated: 2024-05-17
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
CompletedNCT03556358
Tanvex BioPharma USA, Inc.Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer +2
Start: 2018-06-28End: 2021-02-04Updated: 2022-01-14
A Study to Evaluate the Efficacy and Safety of the Combination of TQ-B211 Plus Docetaxel in Patients With HER2-positive MBC.
NCT04385563
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.HER2-positive Metastatic Breast Cancer
Start: 2018-11-11End: 2021-10-31Target: 338Updated: 2020-05-13
A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer
CompletedNCT05629949
Qilu Pharmaceutical Co., Ltd.Breast Cancer
Start: 2020-04-29End: 2023-04-13Updated: 2024-04-23

Related Papers

Updated efficacy and safety of HLX02 versus reference trastuzumab in metastatic HER2-positive breast cancer: A randomized phase III equivalence trial
The Breast2025-02-041 citations
Long-Term Safety and Effectiveness of PF-05280014 (a Trastuzumab Biosimilar) Treatment in Patients with HER2-Positive Metastatic Breast Cancer: Updated Results of a Randomized, Double-Blind Study
BioDrugs2022-01-0112 citations
Efficacy, Safety, and Immunogenicity of HLX02 Compared with Reference Trastuzumab in Patients with Recurrent or Metastatic HER2-Positive Breast Cancer: A Randomized Phase III Equivalence Trial.
2021-04-0726 citations
Abstract P1-18-08: Trazimera (a trastuzumab biosimilar) in HER2-positive metastatic breast cancer: Long-term safety and overall survival data
Cancer Research2020-02-153 citations
Population pharmacokinetics of PF-05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin®) in patients with HER2-positive metastatic breast cancer
Cancer Chemotherapy and Pharmacology2019-05-0315 citations
PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study.
2018-12-2044 citations
Development of PF-05280014, a potential biosimilar to trastuzumab.
Journal of Clinical Oncology2015-05-203 citations