CLINICAL TRIALS PROFILE FOR PERTUZUMAB

Biosimilar Clinical Trials for pertuzumab

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03811418 ↗	A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer	Withdrawn	Amgen	Phase 3	2019-01-01	This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first.
NCT03811418 ↗	A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer	Withdrawn	Arbeitsgemeinschaft fur Internistische Onkologie	Phase 3	2019-01-01	This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first.
NCT03811418 ↗	A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer	Withdrawn	iOMEDICO AG	Phase 3	2019-01-01	This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first.
NCT03988036 ↗	A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1)	Recruiting	Amgen	Phase 2	2020-08-18	Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50.

All Clinical Trials for pertuzumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00058539 ↗	Safety and Efficacy Study of Pertuzumab to Treat Castration-Resistant Prostate Cancer	Completed	Genentech, Inc.	Phase 2	2003-04-01	The purpose of this study is to evaluate safety and efficacy of Omnitarg (Pertuzumab) on cancerous lesions in men with castration-resistant (hormone-refractory) prostate cancer.
NCT00058552 ↗	A Study to Evaluate the Effect of HER2 Activation on rhuMAb 2C4 (Pertuzumab) in Subjects With Advanced Ovarian Cancer	Completed	Genentech, Inc.	Phase 2	2003-05-01	The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced ovarian cancer that is refractory to, or has recurred following, prior chemotherapy.
NCT00063154 ↗	Safety and Effect of Pertuzumab in Patients With Advanced Non-Small Cell Lung Cancer, Which Has Progressed After Prior Chemotherapy	Completed	Genentech, Inc.	Phase 2	2003-07-01	The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced lung cancer that has recurred following prior chemotherapy.
NCT00096941 ↗	A Study to Evaluate Subjects Treated With rhuMab 2C4 (Pertuzumab) in a Previous Genentech Phase II Cancer Study	Completed	Genentech, Inc.	Phase 2	2005-05-01	This is a multicenter, open label extension study. Subjects who have completed treatment in the parent study of pertuzumab, either alone or with a combination agent, and who received at least one dose of pertuzumab in the parent study are eligible for inclusion in this trial if they are continuing to receive clinical benefit.

Clinical Trial Conditions for pertuzumab

Condition Name

Condition Name for pertuzumab
Intervention	Trials
Breast Cancer	116
HER2-positive Breast Cancer	57
Metastatic Breast Cancer	22
Breast Neoplasms	16

Condition MeSH

Condition MeSH for pertuzumab
Intervention	Trials
Breast Neoplasms	238
Neoplasms	13
Carcinoma	12
Adenocarcinoma	8

Clinical Trial Locations for pertuzumab

Trials by Country

Trials by Country for pertuzumab
Location	Trials
Italy	224
Spain	174
China	141
Canada	105
Germany	87

Trials by US State

Trials by US State for pertuzumab
Location	Trials
Texas	51
New York	47
California	45
Florida	40
Massachusetts	39

Clinical Trial Progress for pertuzumab

Clinical Trial Phase

Clinical Trial Phase for pertuzumab
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	8
PHASE2	29

Clinical Trial Status

Clinical Trial Status for pertuzumab
Clinical Trial Phase	Trials
RECRUITING	102
Completed	65
Not yet recruiting	52

Clinical Trial Sponsors for pertuzumab

Sponsor Name

Sponsor Name for pertuzumab
Sponsor	Trials
Hoffmann-La Roche	52
Genentech, Inc.	37
National Cancer Institute (NCI)	17

Sponsor Type

Sponsor Type for pertuzumab
Sponsor	Trials
Other	306
Industry	208
NIH	17

Pertuzumab Market Analysis and Financial Projection

Last updated: February 9, 2026

What is the current status of clinical trials for pertuzumab?

Pertuzumab, marketed as Perjeta by Hoffmann-La Roche, is a monoclonal antibody targeting the HER2 receptor. It is approved for HER2-positive breast cancer at various stages and in combination therapies.

Clinical Trial Landscape (as of Q4 2022):

• Total registered trials: 112
• Active trials: 28, including:
  • Neoadjuvant settings (completion expected 2024)
  • Adjuvant settings (completion expected 2025)
  • Metastatic disease (ongoing, some extensions into combination therapies)
• Major trial programs:
  • APHINITY (Phase III): Evaluates pertuzumab + trastuzumab + chemotherapy in early breast cancer.
  • DESTINY-Breast03 (Phase III): Monoclonal antibody-drug conjugate, yet to impact pertuzumab landscape significantly.
  • Additional trials investigate combination with immune checkpoint inhibitors, targeted therapies, and new formulations.

Recent Approvals and Initiatives:

• Approved for adjuvant treatment of HER2-positive breast cancer in the US (2018) and Europe (2019).
• Expanded label includes neoadjuvant use in certain subpopulations.
• Roche invests in expanding indications, notably in gastric cancer.

What is the market size and how is it evolving?

Current Market Size (2022):

• Global HER2-positive breast cancer drug market estimated at $4.2 billion.
• Pertuzumab's share: approximately 45% of this segment, roughly $1.9 billion.
• US market accounts for nearly 50%, with Europe and China following.

Market Drivers:

• Increasing incidence: breast cancer remains the leading cancer among women globally, with 2.3 million new cases in 2020[1].
• Growing adoption of combination therapies: pertuzumab + trastuzumab + chemotherapy recommended across several treatment lines.
• Expanded indications: neoadjuvant and adjuvant settings bolster sales.

Competitive Landscape:

• Trastuzumab (Herceptin) dominates HER2 therapy.
• Trastuzumab deruxtecan (Enhertu) gaining ground as an antibody-drug conjugate.
• Emerging drugs target resistance and CNS metastasis.

What are sales projections for pertuzumab over the next five years?

Assumptions for projections:

• Market penetration increases in early-stage treatment.
• Regulatory approvals expand into gastric and other cancers.
• No significant patent expirations until 2027.

Projected Sales (2023-2027):

Year	Estimated Market Share	Estimated Revenue (USD billions)
2023	50%	$2.1
2024	55%	$2.3
2025	60%	$2.5
2026	65%	$2.7
2027	70%	$3.0

(Note: These projections assume continued global adoption, approval of new indications, and competitive positioning).

How might regulatory and market dynamics impact pertuzumab’s outlook?

• Regulatory approvals: Successful early and adjuvant trial results could lead to approvals in new indications, boosting sales.
• Patent landscape: When patents expire (expected around 2027), biosimilars entering the market may reduce prices and revenue.
• Pricing policies: Healthcare systems in the US and Europe are increasingly cost-conscious, potentially pressuring margins.
• Competitive therapies: Advances in antibody-drug conjugates and immunotherapies pose threats to pertuzumab's market share.

Key Takeaways

• Pertuzumab remains a core player in HER2-positive breast cancer treatment with ongoing clinical development.
• The drug’s market size stands at approximately $1.9 billion in 2022, with growth driven by expanded indication approvals and increased treatment adoption.
• Sales are projected to grow modestly through 2027, reaching around $3 billion, barring significant market disruptions.
• Patent expirations and biosimilar entry are critical risks, likely beginning around 2027.
• Competitor advances and policy shifts could impact market share and pricing strategies.

FAQs

1. When is pertuzumab expected to lose patent protection?
Patents are expected to expire around 2027, opening the market to biosimilars.

2. Which trials could extend pertuzumab’s approval to new indications?
The ongoing Phase III trials focusing on early-stage and gastric cancers could lead to formal approvals if successful.

3. How does pertuzumab compare to other HER2-targeted therapies?
Pertuzumab is often combined with trastuzumab; while effective, newer agents like trastuzumab deruxtecan show promising activity and could challenge its positioning.

4. What are the main factors influencing pertuzumab’s sales growth?
Market adoption rates, regulatory approvals, biosimilar competition, and health policy changes impact growth.

5. Are there any recent regulatory decisions that could affect pertuzumab?
Recent approvals have reinforced its use in early breast cancer; future decisions hinge on ongoing trial outcomes and emerging data.

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Sources

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