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+ Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer	Withdrawn	Amgen	Phase 3	2019-01-01	This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination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+ Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer	Withdrawn	Arbeitsgemeinschaft fur Internistische Onkologie	Phase 3	2019-01-01	This is a randomized, open-label, two-arm, phase III trial in Germany to investigate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+ Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer	Withdrawn	iOMEDICO AG	Phase 3	2019-01-01	This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple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.
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	Merck Sharp & Dohme Corp.	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.
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	NanoString Technologies, Inc.	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.
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	West German Study Group	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.
NCT00096993 ↗	A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer	Completed	Genentech, Inc.	Phase 2	2005-01-01	This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of pertuzumab in combination with gemcitabine relative to placebo in combination with gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.
NCT00545688 ↗	A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.	Completed	Hoffmann-La Roche	Phase 2	2006-06-26	This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
NCT00551421 ↗	Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2007-10-01	Monoclonal antibodies, such as pertuzumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving pertuzumab together with cetuximab may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of pertuzumab when given together with cetuximab and to see how well they work in treating patients with previously treated locally advanced or metastatic colorectal cancer

Clinical Trial Conditions for pertuzumab

Condition Name

Condition Name for pertuzumab
Intervention	Trials
Breast Cancer	111
HER2-positive Breast Cancer	57
Metastatic Breast Cancer	22
Breast Neoplasms	16

Condition MeSH

Condition MeSH for pertuzumab
Intervention	Trials
Breast Neoplasms	231
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	134
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	20

Clinical Trial Status

Clinical Trial Status for pertuzumab
Clinical Trial Phase	Trials
RECRUITING	100
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	298
Industry	207
NIH	17

Pertuzumab: Clinical Trials Update, Market Analysis, and Projections

Last updated: November 9, 2025

Introduction

Pertuzumab, commercially known as Perjeta, is a monoclonal antibody targeting the HER2 receptor, a critical component in many breast cancer pathologies. Approved by the U.S. Food and Drug Administration (FDA) in 2012 for HER2-positive breast cancer, perturbing signaling pathways that promote tumor growth. Its clinical trajectory, market dynamics, and future outlook are integral to understanding its role within oncology therapeutics. This report provides a comprehensive analysis of recent clinical trials, current market status, and future projections for pertuzumab.

Recent Clinical Trials and Developments

Ongoing and Recent Trials

Pertuzumab continues to be evaluated across multiple studies, notably in expanded indications and combination regimens. Recent trials focus on:

• Neoadjuvant and Adjuvant Settings:
  The APHINITY trial (NCT01358877), a phase III study assessing pertuzumab in early HER2-positive breast cancer, reported 3-year invasive disease-free survival (IDFS) rates, confirming its continued benefit in early-stage disease. Further follow-ups are underway to validate long-term outcomes.

• Combination with Novel Agents:
  The DESTINY-Breast04 trial (NCT03734029), although primarily evaluating trastuzumab deruxtecan, involves combination strategies that include pertuzumab, aiming to assess synergistic effects in HER2-low metastatic breast cancer.

• Expanding to Other Cancers:
  Clinical trials like NCT04644237 explore pertuzumab's efficacy in gastric and gastroesophageal junction cancers, reflecting ongoing efforts to broaden its therapeutic scope.

Key Scientific Advancements

Recent publications strengthen pertuzumab's immunogenic profile, particularly in combination with other HER2-targeted agents, demonstrating improved overall response rates and progression-free survival (PFS). The addition of pertuzumab to trastuzumab and chemotherapy remains superior to trastuzumab alone in HER2-positive breast cancer, as evidenced in the CLEOPATRA study (2012), which remains a cornerstone trial supporting current guidelines.

Safety and Tolerability Updates

Clinical trials continue to affirm pertuzumab's manageable safety profile, primarily associated with diarrhea, alopecia, and infusion reactions. Cardiotoxicity remains monitored, though incidence is low, supporting its integration into multi-agent regimens.

Market Analysis

Market Landscape

Pertuzumab's commercial success is driven by its pivotal role in HER2-positive breast cancer therapy. The global oncology drug market, valued at approximately USD 164.9 billion in 2021 and projected to grow at a CAGR of 7% until 2028 [1], provides a substantial platform for pertuzumab's sustained revenue.

Competitive Position

• Key Competitors:
  Trastuzumab (Herceptin), T-DM1 (Kadcyla), and trastuzumab deruxtecan (Enhertu) dominate the HER2-targeted space. Pertuzumab positions itself as a superior first-line addition, particularly in combination regimens.

• Market Penetration:
  As of 2022, pertuzumab revenues approximated USD 3 billion globally, with significant market penetration in North America and Europe. Its usage is supported by clinical guidelines recommending combined HER2 blockade for early and metastatic disease.

Regulatory Approvals and Expansions

Beyond initial FDA approval for metastatic HER2-positive breast cancer, regulatory bodies, including the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), have extended indications to include adjuvant therapy. Trials exploring HER2-low breast cancer are anticipated to broaden its market ambit.

Pricing and Reimbursement Trends

Pertuzumab's premium pricing strategy reflects its clinical benefits. Pricing strategies vary across regions, influenced by reimbursement policies and healthcare budgets. The drug’s cost-effectiveness remains under ongoing analysis, with recent real-world data supporting its value proposition in combination therapy.

Market Projections

Future Revenue Forecasts

Assuming continued approval for additional indications and competitive positioning, pertuzumab's global sales are projected to reach USD 4.5–5 billion by 2028. Growth drivers include:

• Expansion to HER2-Low Breast Cancer:
  Emerging evidence suggests potential for pertuzumab in HER2-low tumors. If clinical trials demonstrate efficacy, this could unlock a new patient segment, catalyzing double-digit growth.

• Combination Regimens:
  Integration with novel agents, such as antibody-drug conjugates and immune checkpoint inhibitors, is expected to refine treatment paradigms, enhancing sales.

• Regional Growth:
  Emerging markets in Asia-Pacific and Latin America are projected to witness increased adoption due to expanding healthcare access and rising breast cancer incidence.

Challenges and Risks

Potential obstacles include:

• Market Saturation:
  The crowded HER2-targeted therapeutic landscape could limit growth unless new indications or combination benefits are established.

• Pricing and Reimbursement Pressures:
  Healthcare cost containment measures may impact profitability, particularly in price-sensitive markets.

• Competitive Innovations:
  Next-generation therapeutics with superior efficacy or safety profiles could diminish pertuzumab's market share.

Strategic Outlook

Pharmaceutical developers and stakeholders should prioritize:

• Accelerating clinical trials in HER2-low and early-stage settings to unlock untapped markets.
• Developing combination strategies with emerging immuno-oncology agents.
• Engaging with regulatory agencies to expedite approval processes for promising indications.
• Leveraging real-world evidence to demonstrate cost-effectiveness and support reimbursement negotiations.

Preparation for potential market shifts necessitates agility in development pipelines and a focus on precision oncology advancements.

Key Takeaways

• Clinical Development: Pertuzumab remains a cornerstone in HER2-positive breast cancer management, with ongoing trials exploring expanded indications, particularly in HER2-low cases and early-stage disease.

• Market Position: Its substantial current value (~USD 3 billion globally) and demonstrated clinical benefits sustain pertuzumab’s position amid competitive pressure from other HER2-targeted agents.

• Future Opportunities: Rising evidence for HER2-low tumors, novel combination protocols, and expanding regional markets are likely to catalyze revenue growth through 2028, potentially reaching USD 5 billion.

• Challenges: Market saturation, reimbursement constraints, and emerging competitors necessitate proactive strategies in clinical research and market positioning.

• Strategic Focus: Investing in expanding indications, optimizing combination therapies, and engaging regulatory agencies will be key to sustaining and enhancing pertuzumab's market value.

FAQs

1. What is the primary clinical indication for pertuzumab?

Pertuzumab is primarily indicated for HER2-positive breast cancer, including metastatic disease and early-stage settings, as part of combination therapy with trastuzumab and chemotherapy.

2. Are there ongoing trials evaluating pertuzumab in new cancer types?

Yes. Current studies explore pertuzumab's efficacy in gastric/gastroesophageal cancers and HER2-low breast cancers, which could broaden its therapeutic utility.

3. How does pertuzumab's safety profile compare to other HER2-targeted therapies?

Pertuzumab generally exhibits a manageable safety profile, with the most common adverse events being diarrhea and infusion reactions. Cardiotoxicity risk is low but closely monitored, similar to other HER2 inhibitors.

4. What are the key commercial strategies for pertuzumab moving forward?

Developing new indications, expanding regional access, optimizing combination regimens, and engaging with payers for favorable reimbursement are central to future commercial strategies.

5. How might emerging therapies affect pertuzumab's market share?

Innovations such as antibody-drug conjugates and immune checkpoint inhibitors could challenge pertuzumab's dominance unless it adapts through combination therapies and indication expansion.

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Sources:

[1] Grand View Research. Oncology Drugs Market Size, Share & Trends Analysis Report, 2022.