CLINICAL TRIALS PROFILE FOR TRAZIMERA

Biosimilar Clinical Trials for TRAZIMERA

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04266249 ↗	CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy	Recruiting	National Cancer Institute (NCI)	Phase 2	2020-02-11	This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.
NCT04266249 ↗	CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy	Recruiting	ECOG-ACRIN Cancer Research Group	Phase 2	2020-02-11	This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.

All Clinical Trials for TRAZIMERA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Canadian Cancer Trials Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. 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. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Cancer and Leukemia Group B	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. 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. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Eastern Cooperative Oncology Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. 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. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Southwest Oncology Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. 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. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.

Clinical Trial Conditions for TRAZIMERA

Condition Name

Condition Name for TRAZIMERA
Intervention	Trials
Stage IIIA Breast Cancer AJCC v7	7
Stage IIIC Breast Cancer AJCC v7	6
Stage IIIB Breast Cancer AJCC v7	5
Stage IIIA Breast Cancer	5

Condition MeSH

Condition MeSH for TRAZIMERA
Intervention	Trials
Breast Neoplasms	15
Carcinoma	11
Adenocarcinoma	5
Lymphoma	2

Clinical Trial Locations for TRAZIMERA

Trials by Country

Trials by Country for TRAZIMERA
Location	Trials
United States	427
Canada	14
Ireland	7
Puerto Rico	5
South Africa	1

Trials by US State

Trials by US State for TRAZIMERA
Location	Trials
Washington	11
Florida	11
Texas	11
California	11
Minnesota	10

Clinical Trial Progress for TRAZIMERA

Clinical Trial Phase

Clinical Trial Phase for TRAZIMERA
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	6
Phase 1/Phase 2	5

Clinical Trial Status

Clinical Trial Status for TRAZIMERA
Clinical Trial Phase	Trials
Recruiting	11
Active, not recruiting	5
Not yet recruiting	3

Clinical Trial Sponsors for TRAZIMERA

Sponsor Name

Sponsor Name for TRAZIMERA
Sponsor	Trials
National Cancer Institute (NCI)	18
NRG Oncology	5
Jonsson Comprehensive Cancer Center	2

Sponsor Type

Sponsor Type for TRAZIMERA
Sponsor	Trials
Other	21
NIH	18
Industry	6

Clinical Trials Update, Market Analysis, and Projection for TRAZIMERA

Last updated: November 1, 2025

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Introduction

TRAZIMERA (trastuzumab deruxtecan) is an antibody-drug conjugate (ADC) developed by Daiichi Sankyo and AstraZeneca, targeting HER2-expressing cancers. Its approval in various territories has positioned it as a promising therapeutic in HER2-positive breast cancer and other solid tumors. This article provides a comprehensive overview of recent clinical trial developments, market dynamics, and future projections for TRAZIMERA, offering critical insights for stakeholders within the pharmaceutical and healthcare sectors.

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Clinical Trials Update

Recent Phase III Data and Approvals

TRAZIMERA’s clinical journey has been characterized by robust Phase III trial results that support its regulatory approval, notably the DESTINY-Breast03 trial. This pivotal study demonstrated that TRAZIMERA significantly improves progression-free survival (PFS) compared to trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and taxanes. The trial reported a hazard ratio of 0.50 for PFS, signifying a 50% reduction in disease progression risk (source: NEJM, 2021).

Following DESTINY-Breast03, regulatory agencies including the FDA and EMA have granted accelerated and full approvals, respectively, expanding its indications to include earlier lines of therapy.

Ongoing and Planned Trials

Daiichi Sankyo and AstraZeneca continue to expand TRAZIMERA’s potential indications through multiple ongoing Phase Ib/II trials:

• HER2-Positive Gastric and Gastroesophageal Junction Cancers: The DESTINY-Gastric01 trial previously demonstrated meaningful efficacy, prompting further confirmatory studies.
• HER2-Expressing Non-Breast Tumors: Trials are underway evaluating effectiveness in HER2-low metastatic colorectal, lung, and ovarian cancers, aiming to broaden its therapeutic scope.
• Combination Therapies: Trials combining TRAZIMERA with immune checkpoint inhibitors, such as pembrolizumab, aim to enhance anti-tumor activity.

Safety Profile and Adverse Events

Recent data reaffirm TRAZIMERA’s safety, primarily characterized by manageable adverse events. Notable side effects include interstitial lung disease (ILD), fatigue, nausea, and hematologic toxicities. The incidence of ILD remains a critical safety concern, necessitating vigilant monitoring in clinical practice.

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Market Analysis

Current Market Landscape

The global landscape for HER2-targeted therapies is highly competitive, dominated by monoclonal antibodies and ADCs. Notable competitors include trastuzumab (Herceptin), T-DM1 (Kadcyla), and newer ADCs like SYD985. TRAZIMERA's superior efficacy in certain settings, as demonstrated in DESTINY-Breast03, positions it as a potential best-in-class agent for HER2-positive metastatic breast cancer.

• Market Penetration: Since its initial approval in 2022 in the US and Europe, TRAZIMERA has gained significant prescriber adoption within oncology centers, driven by its improved PFS outcomes.
• Pricing and Reimbursement: Its premium positioning is reflected in high pricing strategies tailored to healthcare systems’ reimbursement frameworks, impacting access and uptake.

Key Regional Markets

• United States: The largest market, with extensive clinical adoption, driven by favorable cost-benefit profiles in aggressive HER2-positive breast cancers.
• European Union: Approvals facilitate access throughout member states, with expanding indications prompting increased utilization.
• Asia-Pacific: Emerging markets demonstrate considerable growth potential due to large patient populations and government initiatives promoting innovative oncology treatments.

Market Challenges

• Safety Concerns: ILD risks could restrain prescribing, requiring enhanced clinician education.
• Competitive Pressure: Emerging ADCs and biosimilars threaten market share.
• Cost Constraints: High treatment costs challenge payer acceptance, especially in resource-limited settings.

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Market Projections

Growth Drivers

• Expanding Indications: Continued clinical success and regulatory approvals for earlier lines of therapy forecast increased sales.
• Combination Strategies: Efficacy of combination regimens with immune checkpoint inhibitors will likely expand the target patient pool.
• HER2-Low Tumors: Demonstrated activity in HER2-low breast cancers, which constitute approximately 45-55% of breast cancers, opens up a new sizable market segment.

Forecasted Revenue Trajectory

Analysts project TRAZIMERA’s global sales to escalate from approximately $1.5 billion in 2023 to $6-8 billion by 2028, driven by expanding indications and geographic penetration[1]. The compound annual growth rate (CAGR) is estimated at around 32%, primarily fueled by adoption in HER2-positive metastatic breast cancer and emerging tumor types.

Future Market Opportunities

• Biosimilar Competition: Entry of biosimilars for trastuzumab and other ADCs may affect pricing dynamics.
• Regulatory Approvals: Accelerated approvals in China and Latin America could further accelerate growth.
• Pipeline Advancement: Positive Phase II/III data in other solid tumors could catalyze new indications, substantially impacting sales.

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Strategic Considerations for Stakeholders

• Clinicians: Vigilant monitoring for ILD and educating patients about side effect management are essential for maximizing therapeutic benefit.
• Investors: The robust clinical pipeline and expanding indications suggest long-term growth, albeit with competition and safety considerations.
• Manufacturers: Innovation in ADC technology and combination strategies will be critical for maintaining market relevance.

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Key Takeaways

• TRAZIMERA’s clinical data substantiate its role as a potent HER2-targeted ADC, with recent approvals reflecting its established efficacy.
• The drug’s safety profile warrants careful management of ILD risk, integral to optimizing clinical outcomes.
• Market projections forecast robust growth, driven by expanded indications, combination therapies, and geographic expansion.
• Competition from biosimilars and emerging ADCs requires ongoing innovation and strategic positioning.
• Stakeholders should focus on dosage optimization, safety surveillance, and market access strategies to capitalize on this dynamic growth environment.

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FAQs

1. What are the primary indications for TRAZIMERA?
   TRAZIMERA is primarily approved for HER2-positive metastatic breast cancer, including patients previously treated with trastuzumab and taxanes, with approvals expanding to earlier lines and other HER2-expressing tumors.

2. How does TRAZIMERA compare to other HER2-targeted therapies?
   It has demonstrated superior progression-free survival over T-DM1 in clinical trials, with a unique mechanism of delivering a potent topoisomerase I inhibitor directly to HER2-expressing cancer cells, setting it apart from monoclonal antibodies.

3. What are the main safety concerns associated with TRAZIMERA?
   Interstitial lung disease (ILD) or pneumonitis remains a significant safety concern, alongside manageable hematologic toxicities and gastrointestinal side effects.

4. What is the outlook for TRAZIMERA’s use in non-breast cancers?
   Ongoing trials are exploring its efficacy in gastric, colorectal, lung, and ovarian cancers with HER2 expression, potentially broadening its market reach.

5. When can we expect blockbusters or new indications for TRAZIMERA?
   The next 3-5 years will likely see pivotal trial results that could lead to expanded indications and increased market penetration, supported by regulatory filings in emerging markets.

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References

[1] Market Research Future, 2023. "Global Oncology Drug Market Analysis and Forecast."
[2] NEJM, 2021. "DESTINY-Breast03 Trial Results."
[3] Daiichi Sankyo/AstraZeneca Press Releases, 2022–2023.
[4] EMA and FDA Regulatory Approvals, 2022–2023.