CLINICAL TRIALS PROFILE FOR HERCEPTIN

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.

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.

Clinical Trial Conditions for HERCEPTIN

Condition Name

Condition Name for HERCEPTIN
Intervention	Trials
Breast Cancer	272
HER2-positive Breast Cancer	44
Metastatic Breast Cancer	39
Breast Neoplasms	39

Condition MeSH

Condition MeSH for HERCEPTIN
Intervention	Trials
Breast Neoplasms	444
Stomach Neoplasms	34
Neoplasm Metastasis	31
Carcinoma	24

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

Trials by US State

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

Clinical Trial Progress for HERCEPTIN

Clinical Trial Phase

Clinical Trial Phase for HERCEPTIN
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	7
Phase 3	95

Clinical Trial Status

Clinical Trial Status for HERCEPTIN
Clinical Trial Phase	Trials
Completed	281
Recruiting	62
Active, not recruiting	61

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

Sponsor Type

Sponsor Type for HERCEPTIN
Sponsor	Trials
Other	523
Industry	423
NIH	111

Herceptin (Trastuzumab): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 27, 2025

Introduction

Herceptin (trastuzumab), developed by Genentech (a Roche subsidiary), remains a pivotal therapeutic in the treatment of HER2-positive breast and gastric cancers. Since its initial approval in 1998, Herceptin has dominated the targeted oncology market, due largely to its specificity, proven efficacy, and its role in combination therapies. This report offers a comprehensive update on ongoing clinical trials, market dynamics, and strategic projections for Herceptin through 2030, providing actionable insights for industry stakeholders.

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Clinical Trials Update

Ongoing and Recently Completed Trials

Herceptin’s development pipeline is active, with multiple ongoing trials exploring expanded indications, combination therapies, and resistance management.

• New Indications: Recent Phase III studies evaluate trastuzumab in early-stage HER2-positive gastric cancer (NCT04578921), with preliminary data suggesting improved progression-free survival (PFS) when combined with chemotherapy. Trials for HER2-positive colorectal cancer (NCT02824593) are analyzing efficacy and safety profiles, aiming to expand the therapeutic scope.

• Adjuvant and Neoadjuvant Applications: Trials such as the ALTTO (Adjuvant Lapatinib and Trastuzumab Treatment Optimization) trial have helped optimize dosing regimens in early HER2-positive breast cancer, with newer studies focusing on shorter duration protocols to reduce cardiotoxicity while maintaining efficacy.

• Combination Therapies: The KATHERINE trial (NCT01772472) of trastuzumab emtansine (T-DM1) versus trastuzumab alone continues to inform post-neoadjuvant strategies, with subsequent investigations exploring combinations with immune checkpoint inhibitors (e.g., atezolizumab) in ongoing Phase II and III trials, such as NCT04510051.

• Resistance Mechanisms and Biomarkers: Several studies are analyzing the molecular mechanisms underlying resistance to trastuzumab, including NCT03742570, which investigates HER2 heterogeneity and co-occurring genetic alterations to guide personalized therapy.

Innovations in Delivery and Formulation

Researchers are exploring subcutaneous formulations and biosimilars to improve patient convenience and reduce administration costs. The phase III SOLE Trial (NCT04119064) comparing subcutaneous versus intravenous trastuzumab demonstrated comparable efficacy and improved patient comfort.

Regulatory and Approval Outlook

Recent submissions include an application for HER2-positive early gastric cancer in combination with chemotherapy, with regulatory decisions anticipated in 2023. Biosimilar approvals, such as Samsung Bioepis’s Ontruzant® (trastuzumab-dttb), further diversify the landscape.

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Market Analysis

Market Size and Growth Drivers

The global HER2-targeted therapy market, dominated by Herceptin, was valued at approximately USD 8 billion in 2022. It is projected to grow at a CAGR of 7-8% through 2030, driven by:

• Expanding Indications: Herceptin’s use in early-stage breast and gastric cancers expands its addressable patient population.
• Biosimilar Competition: Biosimilars like Ontruzant® and Herzuma® have reduced costs, increasing accessibility, especially in emerging markets.
• Advances in Combination Therapy: Incorporation with immunotherapy agents is boosting treatment efficacy, leading to increased prescription rates.
• Improved Diagnostics: Enhanced HER2 testing ensures precise patient selection, optimizing outcomes and driving therapy adoption.

Regional Market Dynamics

• North America: The dominant market, accounting for roughly 45-50%, benefits from advanced healthcare infrastructure, early approval of new indications, and high adoption rates.
• Europe: Showing steady growth, fueled by expanding reimbursability and clinical guideline endorsements.
• Asia-Pacific: The fastest-growing segment, with increased access to biosimilars, rising incidence of HER2-positive cancers, and improved healthcare access in China and India.

Competitive Landscape

Herceptin faces competition from biosimilars, particularly in price-sensitive markets, and emerging targeted therapies such as margetuximab and tucatinib, which are gaining regulatory approvals for specific indications.

• Biosimilars: These have undercut Herceptin’s prices by up to 30-40% in certain markets, prompting Roche to optimize pricing strategies and expand indications.
• New Agents: The advent of antibody-drug conjugates (ADCs) like trastuzumab deruxtecan (Enhertu®) has shifted market preferences towards ADCs with superior efficacy in resistant cases.

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Market Projections: 2023-2030

Sales Projections

• 2023–2025: Continual revenue growth driven by expanded indications and biosimilar penetration, with annual sales expected to reach USD 9–10 billion.
• 2026–2030: Stabilization at a higher baseline, with potential decline in mature markets due to biosimilar competition but sustained growth in emerging regions. Total global revenues projected to plateau at around USD 10–12 billion by 2030.

Strategic Growth Opportunities

• Indication Expansion: Pending regulatory approvals in gastric, colorectal, and other HER2-expressing tumors.
• Partnerships and Collaborations: Strategic alliances with biotech firms for combination therapies and biosimilar development.
• Digital and Personalized Medicine: Integration with biomarker-driven diagnostics to enhance patient stratification, improving outcomes and reducing costs.

Market Challenges

• Pricing and Reimbursement Pressures: Increasing emphasis on cost-effectiveness could pressure margins.
• Resistance Development: Rising cases of trastuzumab resistance could restrict long-term efficacy unless complemented with novel agents or treatment strategies.
• Regulatory Hurdles: Evolving global regulatory landscapes may delay approvals for expanded indications or biosimilars.

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Key Takeaways

• Herceptin remains a cornerstone of HER2-positive cancer therapy, with ongoing trials aimed at enhancing its efficacy, safety, and scope.
• The market is experiencing dynamic shifts due to biosimilar competition, new targeted agents, and expanding indications, particularly in Asia-Pacific and emerging markets.
• Future growth hinges on indication expansion, combination therapies, and personalized diagnostics, although regulatory and pricing challenges may temper growth.
• Stakeholders should monitor clinical trial developments closely, leverage biosimilar strategies, and explore therapeutic combinations to sustain profitability.
• The growing prevalence of HER2-positive cancers ensures Herceptin’s relevance, albeit within an increasingly competitive landscape.

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FAQs

1. How are biosimilars affecting Herceptin’s market share?
Biosimilars like Ontruzant® have significantly reduced Herceptin’s price in key markets, leading to increased adoption, especially in price-sensitive regions. This commoditization has compelled Roche to pursue earlier approvals for new indications and optimize pricing strategies to maintain market share.

2. What emerging indications could expand Herceptin’s utilization?
Clinical trials are exploring Herceptin’s efficacy in HER2-positive gastric, colorectal, and lung cancers. If successful, these could add substantial patient populations, bolstering long-term demand.

3. Are there concerns about resistance to Herceptin?**
Yes. Resistance mechanisms include HER2 heterogeneity and downstream pathway mutations. Ongoing research aims to overcome resistance via combination therapies with immune checkpoint inhibitors or novel ADCs.

4. How does Herceptin compare with newer therapies like trastuzumab deruxtecan?
While Herceptin remains effective for early and adjuvant settings, ADCs like trastuzumab deruxtecan demonstrate superior efficacy in resistant metastatic cases. The latter is complementing and, in some cases, replacing Herceptin in later-line therapies.

5. What is the outlook for Herceptin’s use in gastric cancers?
Regulatory approvals are pending for HER2-targeted therapy in gastric cancer, contingent upon promising trial data. An expansion into gastric indications could augment Herceptin’s global market significantly.

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References

[1] Roche. (2022). Herceptin (trastuzumab) Summary of Product Characteristics.
[2] GlobalData. (2023). HER2-Targeted Therapy Market Report.
[3] ClinicalTrials.gov. (2023). List of ongoing and completed trials involving trastuzumab.
[4] WHO. (2022). Cancer statistics and HER2-positive cancer prevalence data.
[5] FDA. (2022). Biosimilar approvals and guideline updates for trastuzumab.