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Last Updated: November 5, 2024

CLINICAL TRIALS PROFILE FOR HERCEPTIN


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Biosimilar Clinical Trials for HERCEPTIN

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT02149524 ↗ A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer Completed Samsung Bioepis Co., Ltd. Phase 3 2014-04-01 A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin® in Women with Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting
NCT03013504 ↗ A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients Active, not recruiting Prestige Biopharma Limited Phase 3 2018-01-01 In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.
NCT03013504 ↗ A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients Active, not recruiting Prestige Biopharma Ltd Phase 3 2018-01-01 In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.
NCT03013504 ↗ A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients Active, not recruiting Prestige Biopharma Pte Ltd Phase 3 2018-01-01 In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.
NCT03084237 ↗ Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer Active, not recruiting Shanghai Henlius Biotech Phase 3 2016-11-01 This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.
NCT03425656 ↗ Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer Completed AryoGen Pharmed Co. Phase 3 2016-07-09 This is A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded, parallel active controlled non-Inferiority clinical trial study to evaluate efficacy and safety of AryoTrust (Aryogen Trastuzumab in comparison to Herceptin® (Genentech/Roche) in patients with Human Epidermal Growth Factor Receptor 2-Positive breast cancer. The main objective is to verify the non-inferiority of AryoTrust (Aryogen trastuzumab) vs. Herceptin® (Genentech/Roche trastuzumab), both given concomitantly with docetaxel after doxorubicin plus cyclophosphamide in the neoadjuvant setting according to pathological complete response (pCR) as primary objective and objective response (cOR), clinical complete response (cCR), clinical partial response (cPR), clinical stable disease (cSD), clinical progressive disease (cPD), breast conservation rate as Secondary objectives of this study. Evaluating the safety and immunogenicity of AryoTrust vs. Herceptin®, are also the other secondary outcomes. This study has two arms and 108 subjects will participate with a 1:1 allocation and receive mentioned treatment randomly.
NCT03989037 ↗ A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer Unknown status Fudan University Phase 3 2019-06-30 The study will compare PK, efficacy, safety, and immunogenicity of SIBP-01 (Trastuzumab Biosimilar) in combination with Docetaxel and Carboplatin versus Herceptin® (CN-Trastuzumab) approved in the CN in combination with Docetaxel and Carboplatin in patients with operable HER2 positive, with early or locally advanced HER2-positive breast cancer. The hypothesis to be tested in this study is the tpCR of patients with Cycle 6 of SIBP-01 is similar to CN-approved trastuzumab, using a 90% bilateral confidence interval between 0.74 and 1.5.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for HERCEPTIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003440 ↗ Paclitaxel With or Without Trastuzumab in Treating Patients With or Without HER-2/Neu Breast Cancer That is Inoperable, Recurrent, or Metastatic Completed National Cancer Institute (NCI) Phase 3 1998-07-01 This randomized phase III studies how well two different regimens of paclitaxel with or without trastuzumab works in treating patients with or without HER-2/Neu breast cancer that is inoperable, recurrent, or metastatic. Drugs used in chemotherapy, such as paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known what regimen of paclitaxel is more effective with or without trastuzumab in treating patients with breast cancer.
NCT00003539 ↗ Paclitaxel Plus Monoclonal Antibody Therapy in Treating Women With Recurrent or Metastatic Breast Cancer Completed National Cancer Institute (NCI) Phase 2 1998-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus monoclonal antibody therapy in treating women with recurrent or metastatic breast cancer.
NCT00003539 ↗ Paclitaxel Plus Monoclonal Antibody Therapy in Treating Women With Recurrent or Metastatic Breast Cancer Completed Memorial Sloan Kettering Cancer Center Phase 2 1998-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus monoclonal antibody therapy in treating women with recurrent or metastatic breast cancer.
NCT00003612 ↗ Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer Completed National Cancer Institute (NCI) Phase 2 1999-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, carboplatin, and trastuzumab in treating women who have metastatic breast cancer that overexpresses HER2.
NCT00003612 ↗ Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer Completed Alliance for Clinical Trials in Oncology Phase 2 1999-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, carboplatin, and trastuzumab in treating women who have metastatic breast cancer that overexpresses HER2.
NCT00003797 ↗ Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas Unknown status National Cancer Institute (NCI) Phase 2 1999-03-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine and trastuzumab in treating patients who have metastatic cancer of the pancreas that overexpresses HER2/neu.
NCT00003797 ↗ Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas Unknown status Brown University Phase 2 1999-03-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine and trastuzumab in treating patients who have metastatic cancer of the pancreas that overexpresses HER2/neu.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for HERCEPTIN

Condition Name

Condition Name for HERCEPTIN
Intervention Trials
Breast Cancer 271
HER2-positive Breast Cancer 44
Metastatic Breast Cancer 39
Breast Neoplasms 39
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Condition MeSH

Condition MeSH for HERCEPTIN
Intervention Trials
Breast Neoplasms 443
Stomach Neoplasms 34
Neoplasm Metastasis 31
Carcinoma 24
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Clinical Trial Locations for HERCEPTIN

Trials by Country

Trials by Country for HERCEPTIN
Location Trials
Italy 313
Spain 241
Brazil 96
Germany 92
Russian Federation 86
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Trials by US State

Trials by US State for HERCEPTIN
Location Trials
California 100
Texas 98
New York 91
Massachusetts 86
Florida 85
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Clinical Trial Progress for HERCEPTIN

Clinical Trial Phase

Clinical Trial Phase for HERCEPTIN
Clinical Trial Phase Trials
Phase 4 7
Phase 3 95
Phase 2/Phase 3 10
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Clinical Trial Status

Clinical Trial Status for HERCEPTIN
Clinical Trial Phase Trials
Completed 280
Recruiting 62
Active, not recruiting 61
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Clinical Trial Sponsors for HERCEPTIN

Sponsor Name

Sponsor Name for HERCEPTIN
Sponsor Trials
National Cancer Institute (NCI) 110
Hoffmann-La Roche 83
Genentech, Inc. 49
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Sponsor Type

Sponsor Type for HERCEPTIN
Sponsor Trials
Other 520
Industry 422
NIH 111
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