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
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.
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
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.

All Clinical Trials for trastuzumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for trastuzumab

Condition Name

Condition Name for trastuzumab
Intervention	Trials
Breast Cancer	458
Metastatic Breast Cancer	114
HER2-positive Breast Cancer	102
Breast Neoplasms	60

Condition MeSH

Condition MeSH for trastuzumab
Intervention	Trials
Breast Neoplasms	851
Stomach Neoplasms	84
Neoplasm Metastasis	59
Adenocarcinoma	54

Clinical Trial Locations for trastuzumab

Trials by Country

+

−

Trials by Country for trastuzumab
Location	Trials
Italy	498
Spain	452
India	87
Poland	84
Mexico	79

Trials by US State

+

−

Trials by US State for trastuzumab
Location	Trials
California	198
New York	186
Texas	180
Florida	169
Massachusetts	145

Clinical Trial Progress for trastuzumab

Clinical Trial Phase

Clinical Trial Phase for trastuzumab
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	200
Phase 2/Phase 3	17

Clinical Trial Status

Clinical Trial Status for trastuzumab
Clinical Trial Phase	Trials
Completed	429
Recruiting	209
Not yet recruiting	139

Clinical Trial Sponsors for trastuzumab

Sponsor Name

Sponsor Name for trastuzumab
Sponsor	Trials
National Cancer Institute (NCI)	130
Hoffmann-La Roche	122
Genentech, Inc.	78

Sponsor Type

Sponsor Type for trastuzumab
Sponsor	Trials
Other	1079
Industry	836
NIH	132

Trastuzumab: Clinical Trials, Market Analysis, and Projections

Introduction to Trastuzumab

Trastuzumab, a monoclonal antibody targeting the HER2 receptor, has been a cornerstone in the treatment of HER2-positive breast cancer and other HER2-overexpressing cancers. Here, we delve into the latest clinical trials, market analysis, and projections for this pivotal drug.

Current Clinical Trials and Developments

Advanced HER2-Positive Breast Cancer

The standard of care (SOC) for metastatic HER2-positive breast cancer has remained largely unchanged for over a decade, involving a taxane plus trastuzumab and pertuzumab. However, several ongoing clinical trials are poised to challenge this status quo.

• DESTINY-Breast09 Trial: This phase 3 trial, which has completed accrual, compares trastuzumab deruxtecan (T-DXd) plus placebo, T-DXd plus pertuzumab, and the current SOC (trastuzumab plus pertuzumab and docetaxel). Initial data from this trial, anticipated in 2025, could establish a new first-line SOC for patients with HER2-positive metastatic breast cancer[1].

• Other Ongoing Trials: Trials such as HER2CLIMB-05, PATINA, INAVO122, and the phase 2 DEMETHER study are exploring the addition of targeted therapeutics to maintenance regimens involving trastuzumab and pertuzumab. These studies aim to enhance the durability of the first-line treatment[1].

Trastuzumab in Other Cancers

Non-Small Cell Lung Cancer (NSCLC)

The DESTINY-Lung01 study is evaluating the antitumor activity and safety of trastuzumab deruxtecan in patients with HER2-overexpressing or HER2-mutant NSCLC. This phase 2 study indicates that trastuzumab deruxtecan may fill a significant unmet need in this patient population, given the limited efficacy of current treatments[3].

Market Analysis and Projections

Global Market Size and Growth

The trastuzumab market is experiencing exponential growth driven by several factors:

• Market Size: The trastuzumab market was valued at $4.27 billion in 2023 and is projected to reach $16.28 billion by 2031, growing at a compound annual growth rate (CAGR) of 25.0% during the forecast period 2024-2031[5].

• Biosimilars Market: The trastuzumab biosimilars market is also growing rapidly, expected to reach $14.69 billion by 2028 at a CAGR of 28.3%. This growth is attributed to increased market competition, development of biosimilar pipelines, regulatory approvals, and enhanced global market penetration[2].

Regional Dynamics

• North America: This region, particularly the United States and Canada, holds a significant share of the trastuzumab market due to advanced healthcare infrastructure and high investment in biotechnology[5].

• Europe: Countries like Germany, France, and the UK contribute substantially to the market, supported by robust regulatory frameworks and public healthcare initiatives[5].

• Asia-Pacific: This region is also seeing significant growth, driven by increasing awareness of personalized medicine and improving healthcare infrastructure.

Factors Driving Market Growth

Regulatory Approvals and Standardizations

Regulatory approvals and standardizations play a crucial role in the growth of the trastuzumab market. Enhanced regulatory frameworks, especially in Europe, ensure high standards for cancer treatment options, facilitating market growth[2].

Physician Adoption and Patient Preference

Increased acceptance among physicians and patient preference for biosimilars are key drivers. Educational campaigns and strategies for market segmentation further contribute to the market's expansion[2].

Clinical Trial Outcomes

Positive outcomes from clinical trials, such as the potential for trastuzumab deruxtecan to disrupt current treatment regimens, are pivotal in driving market growth and changing treatment paradigms[1].

Adjuvant Trastuzumab: Long-Term Outcomes

Duration of Adjuvant Trastuzumab

Studies have compared the outcomes of different durations of adjuvant trastuzumab. A secondary analysis of a randomized clinical trial showed that 1 year of adjuvant trastuzumab significantly improves disease-free survival compared to a 9-week regimen. This underscores the importance of the duration of trastuzumab administration in adjuvant treatment[4].

Key Takeaways

• Clinical Trials: Ongoing trials like DESTINY-Breast09 and others are set to redefine the treatment landscape for HER2-positive breast cancer.
• Market Growth: The trastuzumab market is expected to grow significantly, driven by biosimilars, regulatory approvals, and increasing global demand.
• Regional Dynamics: North America and Europe are key markets, with the Asia-Pacific region showing promising growth.
• Adjuvant Treatment: Long-term outcomes highlight the importance of 1-year adjuvant trastuzumab for improved disease-free survival.

FAQs

What is the current standard of care for metastatic HER2-positive breast cancer?

The current standard of care involves a taxane plus trastuzumab and pertuzumab, a regimen that has remained largely unchanged for over a decade[1].

What are the key ongoing clinical trials for trastuzumab?

Key trials include DESTINY-Breast09, HER2CLIMB-05, PATINA, INAVO122, and the phase 2 DEMETHER study, which are exploring new treatment regimens and maintenance therapies[1].

How is the trastuzumab market expected to grow?

The trastuzumab market is projected to reach $16.28 billion by 2031, growing at a CAGR of 25.0% during the forecast period 2024-2031[5].

What role do biosimilars play in the trastuzumab market?

Biosimilars are expected to grow significantly, reaching $14.69 billion by 2028, driven by market competition, regulatory approvals, and global market penetration[2].

What is the impact of adjuvant trastuzumab duration on patient outcomes?

Studies have shown that 1 year of adjuvant trastuzumab significantly improves disease-free survival compared to shorter durations, such as 9 weeks[4].

Sources

1. Research Propels Additional Options into the Advanced HER2+ Breast Cancer Armamentarium. Onclive.
2. Trastuzumab Biosimilars Global Market Size & Competitors. ResearchAndMarkets.
3. Trastuzumab deruxtecan in patients with metastatic non-small-cell lung cancer. The Lancet.
4. Long-Term Outcomes of Adjuvant Trastuzumab for 9 Weeks or 1 Year. JAMA Network Open.
5. Trastuzumab Market Size, Scope, Growth, Trends and Forecast. Verified Market Research.