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.

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.

Clinical Trial Conditions for Trastuzumab

Condition Name

Condition Name for Trastuzumab
Intervention	Trials
Breast Cancer	494
HER2-positive Breast Cancer	131
Metastatic Breast Cancer	127
Breast Neoplasms	63

Condition MeSH

Condition MeSH for Trastuzumab
Intervention	Trials
Breast Neoplasms	913
Stomach Neoplasms	98
Neoplasm Metastasis	68
Adenocarcinoma	54

Clinical Trial Locations for Trastuzumab

Trials by Country

Trials by Country for Trastuzumab
Location	Trials
Italy	520
China	501
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	35
PHASE2	89

Clinical Trial Status

Clinical Trial Status for Trastuzumab
Clinical Trial Phase	Trials
Completed	433
Recruiting	303
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	1220
Industry	918
NIH	137

Trastuzumab Clinical Trials Update and Market Projection

Last updated: April 24, 2026

Trastuzumab (HER2-targeting antibody, branded as Herceptin in multiple geographies) is an established oncology asset with an active life-cycle across breast, gastric/GEJ, and metastatic settings. The current market trajectory is shaped by (1) patent-driven erosion from biosimilar competition in key markets, (2) label expansion work across combinations and new dosing regimens, and (3) conversion of treatment pathways to next-generation HER2 standards in some settings.

What is the current clinical-trials status for trastuzumab?

Trastuzumab is not a “single-study” drug at this point; it sits inside ongoing combination programs, real-world evidence efforts, and comparator trials in HER2-positive disease. Trial activity clusters around three themes: (1) optimizing treatment duration and sequencing, (2) expanding use in earlier lines with fixed-interval regimens and combination backbones, and (3) evaluating trastuzumab-containing regimens alongside newer HER2 agents.

Trial activity pattern (high-level, current):

• Breast cancer: late-stage trials and label-maintenance studies in HER2-positive metastatic disease and earlier-stage risk populations; combination backbones remain the dominant study design.
• Gastric/GEJ cancer: comparator trials and combination regimen work in HER2-positive disease, including maintenance and first-line strategy optimization.
• Biomarker and sequencing work: studies using HER2 testing strategy and treatment sequencing endpoints (response durability, progression-free survival, and subsequent therapy impacts).

Operational implication: For investors and R&D planners, “trastuzumab development” is less about discovering new biology and more about maintaining competitive positioning through regimen optimization, combination selection, and integration into evolving standard-of-care pathways.

Where does trastuzumab sit in the competitive landscape?

Trastuzumab’s market position is constrained less by efficacy and more by competitive entry and treatment guideline evolution.

Biosimilars: price competition is the primary market driver

In multiple jurisdictions, biosimilar trastuzumab has entered and expanded, compressing pricing versus originator Herceptin. That drives:

• share shifts from originator to biosimilar products
• margin pressure for the originator brand
• faster payor adoption cycles due to therapeutic interchange policies

Next-generation HER2 therapies: pathway substitution risk

Across HER2-positive breast and gastric/GEJ oncology, newer modalities (including antibody-drug conjugates and bispecific approaches) gradually alter first-line and subsequent-line treatment choice in some geographies. Trastuzumab remains a core backbone in many regimens, but the competitive effect is real in the segments where newer agents gain preferred status.

Implication for projection: market growth is not purely a function of incidence. It is also a function of relative uptake of trastuzumab versus newer HER2 agents and of payer behavior shifting to biosimilars.

What does the market look like by region and segment?

Trastuzumab demand is anchored in two principal indications:

1. HER2-positive breast cancer
2. HER2-positive gastric and gastroesophageal junction cancer

In business terms, forecast models typically break demand into:

• Units: treated patients, dose and regimen duration, and line-of-therapy conversion
• Net price: originator vs biosimilar mix and annual price erosion
• Coverage: payer adoption, guideline alignment, and switch policies

Segment demand structure (practical view)

• Breast cancer: largest volume base, with growth influenced by early-stage treatment intensification and duration strategies
• Gastric/GEJ: smaller volume base but important due to guideline status in HER2-positive disease and ongoing combination regimen work

How should projections be modeled under biosimilar erosion?

A robust projection for trastuzumab should model three coupled levers: volume, price, and share.

1) Volume: driven by incidence and regimen inclusion

• The number of eligible HER2-positive patients and adherence to testing practices drive addressable volume.
• Treatment sequencing affects how many regimens include trastuzumab (and whether it remains a backbone in later lines).

2) Price: originator-to-biosimilar mix shift

• As biosimilar penetration rises, weighted average selling price (WASP) declines.
• Duration and dosing changes can increase units per patient, but price erosion often dominates revenue direction.

3) Share: payor switching and prescriber behavior

• Policies that allow interchange and encourage biosimilar uptake accelerate share changes.
• Brand-specific programs (patient access support, contracting strategy) can slow but rarely reverse structural price pressure.

Net effect typically observed in mature biologics: revenue growth can remain flat or negative while unit use stays stable or grows modestly.

What is the projected market trajectory for trastuzumab (base-case structure)?

Below is the projection framework used for decision-grade modeling of trastuzumab commercialization under maturity, biosimilar entry, and competitive substitution.

Forecast logic (base-case)

• Units: stable to modest growth, supported by persistent HER2-positive patient demand and regimen inclusion.
• Net sales: pressured by biosimilar-driven price compression and ongoing pathway shifts toward newer HER2 agents.
• Regional variation: faster erosion where biosimilar adoption is aggressive and tendering is routine; slower where originator contracts remain longer.

Scenario set

Use three scenarios for investment decisions:

Bull case

• slower price erosion due to slower biosimilar adoption in key contracts
• greater persistence of trastuzumab backbone regimens in metastatic and adjuvant settings
• fewer rapid pathway switches to newer agents in high-volume segments

Base case

• continued biosimilar mix shift and gradual WASP decline
• trastuzumab remains backbone in a portion of lines of therapy, with partial substitution by newer HER2 modalities

Bear case

• accelerated tender-driven switching
• increasing preference for trastuzumab-free or trastuzumab-reduced regimens in major guideline updates
• steeper erosion from increased biosimilar entrants and competitive contracting

What clinical signals matter most for business outcomes?

Trastuzumab clinical value is already established. The business-critical signals are those that change utilization patterns:

• Non-inferiority or improved outcomes for shortened or optimized duration regimens
  These can reduce treatment costs for payors and raise acceptance for trastuzumab-containing protocols.
• Evidence that supports broader combination inclusion
  If guidelines place trastuzumab backbones more frequently in standard regimens, units can hold up even in pricing pressure.
• Sequence-of-therapy data
  Trials and real-world studies indicating that trastuzumab remains a viable backbone before or after newer HER2 agents can preserve line-of-therapy share.
• Safety and tolerability reaffirmation
  Mature drugs often see utilization maintained if safety profiles remain consistent and manageable.

What are the business implications by stakeholder?

For R&D strategy

• The competitive frontier is not “trastuzumab as monotherapy.” It is integration into multi-agent HER2 strategies.
• Development programs should target trial endpoints that drive guideline adoption: sequence fit, regimen durability, and payer-relevant outcomes.

For investment allocation

• Treat trastuzumab as a mature revenue stream with structural price decline risk from biosimilars.
• Upside comes from utilization persistence and contracting resilience, not from step-change clinical differentiation.

For commercialization and market access

• The core KPI is biosimilar penetration pace and net price retention via contracting.
• Local payer behavior (formularies, step edits, tendering cadence) often dominates revenue outcomes.

Key Takeaways

• Trastuzumab is a mature HER2 backbone with ongoing clinical activity focused on regimen optimization, combination integration, and treatment sequencing.
• Market trajectory is dominated by biosimilar erosion and gradual substitution risk from newer HER2 agents, while unit demand remains supported by persistent HER2-positive disease load.
• Projections should be built on units (patient and regimen inclusion) plus net price (originator-to-biosimilar mix), with scenario-based assumptions for guideline shifts.
• Business upside is most likely to come from utilization persistence (backbone role retention) rather than pricing recovery.

FAQs

1) Is trastuzumab still under active clinical trial development?

Yes. Current activity is largely regimen-level optimization and combination/sequence studies rather than new mechanism discovery.

2) What is the biggest market risk for trastuzumab?

Biosimilar-driven price erosion and contract-driven switching, plus partial pathway substitution toward newer HER2 agents.

3) What indications drive trastuzumab demand?

HER2-positive breast cancer and HER2-positive gastric or gastroesophageal junction cancer.

4) How should investors think about revenue versus unit trends?

Units can be stable to modestly growing while revenue declines due to weighted average selling price compression from biosimilars.

5) What clinical evidence most influences market access outcomes?

Data that changes treatment duration, strengthens combination standard-of-care placement, or clarifies sequence-of-therapy fit with emerging HER2 agents.

---

References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Herceptin (trastuzumab) prescribing information. FDA. https://www.accessdata.fda.gov
[2] European Medicines Agency. (n.d.). Herceptin product information. EMA. https://www.ema.europa.eu
[3] National Comprehensive Cancer Network. (n.d.). NCCN Guidelines: Breast Cancer. NCCN. https://www.nccn.org
[4] National Comprehensive Cancer Network. (n.d.). NCCN Guidelines: Gastric Cancer. NCCN. https://www.nccn.org
[5] ClinicalTrials.gov. (n.d.). Trastuzumab studies. U.S. National Library of Medicine. https://clinicaltrials.gov