CLINICAL TRIALS PROFILE FOR TRASTUZUMAB

Biosimilar Clinical Trials for trastuzumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01439191 ↗	Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer	Completed	Shanghai CP Guojian Pharmaceutical Co., Ltd.	Phase 2	2005-07-01	The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved a valuable treatment for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical Co.Ltd. Efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast cancer.
NCT01439191 ↗	Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer	Completed	Shanghai CP Guojian Pharmaceutical Co.,Ltd.	Phase 2	2005-07-01	The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved a valuable treatment for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical Co.Ltd. Efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast cancer.
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.

All Clinical Trials for trastuzumab

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.

Clinical Trial Conditions for trastuzumab

Condition Name

Condition Name for trastuzumab
Intervention	Trials
Breast Cancer	489
HER2-positive Breast Cancer	128
Metastatic Breast Cancer	126
Breast Neoplasms	63

Condition MeSH

Condition MeSH for trastuzumab
Intervention	Trials
Breast Neoplasms	905
Stomach Neoplasms	96
Neoplasm Metastasis	68
Neoplasms	54

Clinical Trial Locations for trastuzumab

Trials by Country

Trials by Country for trastuzumab
Location	Trials
Italy	520
China	485
Spain	466
Poland	89
Mexico	79

Trials by US State

Trials by US State for trastuzumab
Location	Trials
California	210
New York	199
Texas	196
Florida	182
Massachusetts	157

Clinical Trial Progress for trastuzumab

Clinical Trial Phase

Clinical Trial Phase for trastuzumab
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	33
PHASE2	70

Clinical Trial Status

Clinical Trial Status for trastuzumab
Clinical Trial Phase	Trials
Completed	433
Recruiting	294
Not yet recruiting	139

Clinical Trial Sponsors for trastuzumab

Sponsor Name

Sponsor Name for trastuzumab
Sponsor	Trials
National Cancer Institute (NCI)	135
Hoffmann-La Roche	123
Genentech, Inc.	79

Sponsor Type

Sponsor Type for trastuzumab
Sponsor	Trials
Other	1197
Industry	914
NIH	137

Clinical Trials Update, Market Analysis, and Projection for Trastuzumab

Last updated: October 31, 2025

Introduction

Trastuzumab, a monoclonal antibody targeting the human epidermal growth factor receptor 2 (HER2), revolutionized breast cancer treatment since its approval. Its efficacy spans HER2-positive breast cancer, gastric, and gastroesophageal junction cancers. As the therapeutic landscape evolves with emerging biosimilars and combination regimens, understanding recent clinical developments, market dynamics, and future projections is critical for stakeholders across pharma, healthcare, and investment sectors.

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Clinical Trials Update

Current Clinical Landscape

Recent years have seen an acceleration in clinical trials evaluating trastuzumab's utility, including novel formulations, biosimilars, and expanded indications. Notably:

• Enhanced Combination Therapy Trials: Multiple studies investigate trastuzumab combined with immune checkpoint inhibitors such as pembrolizumab, aiming to enhance anti-tumor immunity. For example, NCT03835719 is evaluating trastuzumab with pembrolizumab in HER2-positive metastatic breast cancer, aiming to improve response rates and progression-free survival (PFS).

• Adjuvant and Neoadjuvant Studies: Trials such as the KATHERINE study (NCT01772472) demonstrated improved invasive disease-free survival (IDFS) with trastuzumab emtansine (T-DM1) versus trastuzumab alone as adjuvant therapy, cementing its role in early-stage disease management.

• Biosimilar Development: Several biosimilar candidates are in late-phase trials, including MSB11455 and CT-P6, aiming to reduce therapy costs and expand access. These have demonstrated comparable efficacy and safety to innovator trastuzumab in phase III trials, such as the PLANET and HERITAGE studies.

• New Formulations and Extended Indications: Investigations into subcutaneous formulations (e.g.,atumab) focus on improved patient convenience, with phase III data indicating comparable pharmacokinetics and safety.

Keynote Trials and Outcomes

• HER2-Positive Breast Cancer: Trials like HER2CLIMB (NCT02614783) assess trastuzumab combined with tucatinib, demonstrating notable PFS benefits versus standard therapies.

• Gastric Cancer: Trials such as INTEGRATE II (NCT03278289) explore trastuzumab combined with chemotherapy in first-line metastatic gastric cancer, with interim results indicating survival benefits.

Regulatory and Approval Updates

Recent approvals include:

• The FDA's greenlighting of trastuzumab deruxtecan (Enhertu) for HER2-low metastatic breast cancer underscores the expanding utility of HER2-targeted therapies beyond traditional HER2-positive tumors.

• Investigations into real-world effectiveness and biomarker-driven response predictability continue, informing future indications.

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Market Analysis

Market Size and Growth Dynamics

The trastuzumab market has historically generated over $6 billion annually globally, driven predominantly by breast and gastric cancers [1]. Factors influencing growth include:

• Rising Incidence: Breast cancer remains the most common cancer worldwide, with an estimated 2.3 million diagnoses in 2020 [2]. HER2 positivity occurs in approximately 15-20% of cases, underpinning continued demand.

• Expanding Indications: Warmer regulatory acceptance for trastuzumab in gastric and gastroesophageal cancers broadens market scope.

• Biosimilars Entry: The launch of biosimilars such as Pfizer's Trazimera and Samsung Bioepis's Ontruzant has led to significant price competition, reducing treatment costs and increasing accessibility. Biosimilar adoption increased substantially, with estimates suggesting biosimilars could comprise 70% of trastuzumab prescriptions in Europe by 2025 [3].

• Pipeline and Novel Combinations: The integration of trastuzumab with agents like pertuzumab and T-DM1 contraindicates monotherapy and supports incremental revenue streams.

Regional Market Dynamics

• North America: Dominates the market owing to high breast cancer prevalence, advanced healthcare infrastructure, and high R&D investment.

• Europe: Markets are witnessing rapid biosimilar adoption, driven by ESMO guidelines favoring cost-effective therapies.

• Asia-Pacific: Rapidly expanding due to increasing cancer incidence, healthcare infrastructure investment, and governmental policies favoring biosimilar integration.

Competitive Landscape

Key players include Roche (original trastuzumab), Amgen, Pfizer, Samsung Bioepis, and Celltrion. Roche retains market leadership, though biosimilar entrants have captured significant shares, especially post patent expiry (e.g., patent expiration in 2018).

Revenue Projections

Analysts forecast the global trastuzumab market will reach approximately $8-10 billion by 2030, reflecting compounded annual growth rates (CAGR) of 4-5%. This reflects strong demand, biosimilar proliferation, and potential expansion into HER2-low tumors with drugs like trastuzumab deruxtecan.

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Projections for the Future

Market Trends

• Biosimilars Domination: Expected to account for over 70% of trastuzumab prescriptions by mid-2020s, leading to significant cost reductions and increased access, especially in emerging markets.

• Personalized Medicine Expansion: Molecular diagnostics and biomarkers will refine patient selection, optimizing outcomes and resource utilization.

• Combination and Novel Formulations: Expect increased adoption of subcutaneous injections and combination regimens with immunotherapies, improving patient convenience and treatment efficacy.

• Regulatory Advances: Broader approvals for HER2-low tumors and other off-label indications, along with increased participation in global clinical trials, will further shape market growth.

Potential Market Challenges

• Biosimilar Validation and Acceptance: While biosimilars reduce costs, physician acceptance varies based on clinical data and regulatory confidence.

• Pricing Pressures: Governments and payers are increasingly negotiating prices, and competitive biosimilar entries could compress revenues.

• Emerging Therapies: Competition from antibody-drug conjugates like trastuzumab deruxtecan presents therapeutic challenges, potentially shifting market share.

Long-term Outlook

A sustained CAGR of approximately 4-6% through 2030 appears plausible, supported by biosimilar adoption, expanded indications, and combination therapies. The integration of trastuzumab into broader personalized treatment algorithms will likely sustain its relevance.

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Key Takeaways

• Recent clinical trials reinforce trastuzumab’s role in combination regimens, early-stage management, and emerging indications such as HER2-low tumors.

• The market is experiencing rapid growth driven by biosimilar commercialization, rising global incidence of HER2-positive cancers, and innovative formulations.

• Biosimilars are transforming market dynamics, reducing treatment costs, and expanding access, especially in emerging markets.

• Future market growth hinges on regulatory acceptance of new indications, combination strategies, and personalized medicine approaches.

• Competitive pressures from novel therapies and biosimilars necessitate continuous innovation and strategic adaptation by stakeholders.

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FAQs

1. What are the latest clinical developments involving trastuzumab?
Recent trials focus on combination therapies with immunotherapies, biosimilar efficacy, and expanding indications to HER2-low cancers, demonstrating enhanced efficacy and broader applicability.

2. How is the biosimilar market impacting trastuzumab's revenues?
Biosimilars have significantly lowered prices, increasing prescription volumes, especially in Europe and emerging markets, thereby reducing overall revenues for original manufacturers but expanding market access.

3. What is the outlook for trastuzumab in HER2-low breast cancers?
With approvals of trastuzumab deruxtecan and ongoing trials, the treatment landscape is shifting toward including HER2-low tumors, promising new market segments and increased sales.

4. Which regions are leading in trastuzumab market growth?
North America and Europe lead due to high prevalence, healthcare infrastructure, and biosimilar adoption; Asia-Pacific offers growth potential driven by cancer incidence and policy shifts.

5. How do emerging therapies compare with trastuzumab?
Antibody-drug conjugates like trastuzumab deruxtecan are showing promising efficacy, potentially overshadowing trastuzumab in certain settings, but trastuzumab remains foundational in HER2-positive cancers.

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References

[1] IQVIA. (2022). Global Oncology Market Data.

[2] World Health Organization. (2021). Breast Cancer Fact Sheet.

[3] EvaluatePharma. (2022). Biosimilar Market Trends and Forecasts.