CLINICAL TRIALS PROFILE FOR PERJETA

Biosimilar Clinical Trials for PERJETA

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.
NCT05346224 ↗	A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer	Recruiting	Shanghai Henlius Biotech	Phase 3	2022-04-25	This is a phase III, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of pertuzumab biosimilar HLX11 vs. EU-Perjeta® on HER2-positive and HR-negative early-stage or locally advanced breast cancer with a primary tumor > 2 cm. Patients are random assignment to 2 arms and treatment with either HLX11 or EU-Perjeta® , and received neoadjuvant THP regimen every 3- weeks 4 cycles，adjuvant AC every 3- weeks 4 cycles and pertuzumab+trastuzumab(HP) every 3- weeks 13cycles.
NCT05471648 ↗	A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers	Recruiting	Sacura GmbH	Phase 1	2022-05-16	This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single intravenous (i.v.) infusion to both European Union (EU) and United States of America (US) reference products.
NCT05471648 ↗	A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers	Recruiting	EirGenix, Inc.	Phase 1	2022-05-16	This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single intravenous (i.v.) infusion to both European Union (EU) and United States of America (US) reference products.
NCT05738993 ↗	A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers	Active, not recruiting	Biocad	Phase 1	2022-08-08	This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male volunteers

All Clinical Trials for PERJETA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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
NCT00567190 ↗	A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer	Completed	Hoffmann-La Roche	Phase 3	2008-02-12	This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment. Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.
NCT00567190 ↗	A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer	Completed	Genentech, Inc.	Phase 3	2008-02-12	This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment. Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.
NCT00781612 ↗	A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies	Recruiting	Hoffmann-La Roche	Phase 2	2008-10-16	This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.
NCT00781612 ↗	A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies	Recruiting	Genentech, Inc.	Phase 2	2008-10-16	This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.
NCT00855894 ↗	A Study of the Combination of Erlotinib and Pertuzumab in Patients With Relapsed Non-small Cell Lung Cancer	Completed	Roche Pharma AG	Phase 2	2009-03-01	This was a Phase II, open-label, single-arm, single-stage, multicenter trial in patients with relapsed non-small cell lung cancer (NSCLC), with the objective of assessing the activity of the combination of erlotinib and pertuzumab on the basis of the endpoint of FDG-PET response rate.

Clinical Trial Conditions for PERJETA

Condition Name

Condition Name for PERJETA
Intervention	Trials
Breast Cancer	39
HER2-positive Breast Cancer	19
Breast Neoplasms	9
Metastatic Breast Cancer	7

Condition MeSH

Condition MeSH for PERJETA
Intervention	Trials
Breast Neoplasms	90
Neoplasms	10
Carcinoma	9
Neoplasm Metastasis	6

Clinical Trial Locations for PERJETA

Trials by Country

Trials by Country for PERJETA
Location	Trials
United States	562
Italy	121
Spain	68
Canada	49
Brazil	44

Trials by US State

Trials by US State for PERJETA
Location	Trials
Texas	28
California	21
Massachusetts	21
New York	19
Florida	19

Clinical Trial Progress for PERJETA

Clinical Trial Phase

Clinical Trial Phase for PERJETA
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
Phase 3	29

Clinical Trial Status

Clinical Trial Status for PERJETA
Clinical Trial Phase	Trials
Completed	37
Recruiting	32
Active, not recruiting	21

Clinical Trial Sponsors for PERJETA

Sponsor Name

Sponsor Name for PERJETA
Sponsor	Trials
Hoffmann-La Roche	30
Genentech, Inc.	16
National Cancer Institute (NCI)	12

Sponsor Type

Sponsor Type for PERJETA
Sponsor	Trials
Other	119
Industry	97
NIH	12

Last updated: April 27, 2026

PERJETA (pertuzumab): Clinical Trials Update and Market Outlook

What is PERJETA’s current clinical posture?

PERJETA is the branded name for pertuzumab, a monoclonal antibody targeting HER2. In clinical development and label expansion, the backbone regimen is pertuzumab + trastuzumab + chemotherapy for HER2-positive breast cancer, with additional uses in earlier-stage settings and metastatic disease. The most commercially relevant clinical program elements remain anchored to phase 3 outcomes that established benefit in combination therapy.

Key late-stage evidence that drives today’s regimen

• CLEOPATRA (metastatic HER2-positive breast cancer): Pertuzumab added to trastuzumab + docetaxel improves overall survival (OS) and progression-free survival (PFS), making the 1L standard.
• APHINITY (early-stage HER2-positive breast cancer at high risk of recurrence): Pertuzumab added to adjuvant trastuzumab-based chemotherapy improves invasive disease-free survival (IDFS) in node-positive and other higher-risk groups.

These pivotal outcomes remain the clinical basis for ongoing commercial use in both metastatic and adjuvant settings. (See sources: [1], [2].)

Ongoing and follow-on clinical directions (label and practice continuity)

In practice, current use is less about new mechanism trials and more about:

• Expanding or refining patient subgroups (tumor risk features, baseline disease burden).
• Optimizing combination strategies (chemo backbones, sequencing, and peri-operative treatment models where permitted by label).
• Evaluating outcomes in specific high-risk populations where HER2 positivity intersects with other prognostic markers.

Actionable read-through for R&D and investments: the pertuzumab portfolio is mature; new trials typically aim to improve sequencing, reduce toxicity, or define use in narrower clinical segments rather than replace pertuzumab’s position in HER2 combination regimens. This reduces probability of rapid “incumbent displacement” from a rival antibody unless a competitor demonstrates clear superiority in OS or IDFS within the same treatment lines.

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What does the PERJETA market look like now?

PERJETA is a high-value biologic within HER2-positive oncology. Market performance is driven by:

• HER2 testing penetration (identifying eligible patients).
• Treatment guideline adherence in metastatic and adjuvant settings.
• Competitive dynamics in HER2 antibodies and antibody-drug conjugates (ADCs), which primarily affect share rather than eliminate the HER2 class demand.

Competitive context

The market sits in a crowded HER2 landscape that includes:

• Other HER2 antibodies (trastuzumab biosimilars have pressure points on trastuzumab pricing in many markets).
• HER2 ADCs (e.g., trastuzumab deruxtecan in later lines) that can shift subsequent-line economics.

The practical implication is that pertuzumab demand is most resilient when it is used early (1L metastatic and adjuvant high-risk settings). Later-line switching to ADCs does not fully erase pertuzumab because it is entrenched earlier in care pathways.

Commercial logic for projection

For projection purposes, demand is modeled primarily by:

• Growth in treated HER2-positive populations (largely dependent on incidence and testing).
• Retention of pertuzumab in standard-of-care combinations across regions.
• Erosion effects from:
  • changes in metastatic sequencing (ADC uptake),
  • biosimilar penetration on companion trastuzumab,
  • pricing pressure and payer controls.

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How will the PERJETA market likely evolve through the forecast window?

Projection framework (business-useful, not academic):

1. Base demand stability in metastatic 1L (CLEOPATRA regimen usage) because it is a category-defining OS-improving combination. (See [1].)
2. Adjuvant contribution from APHINITY-defined high-risk early-stage patients, supporting a steady tail of demand. (See [2].)
3. Share pressure as:
   • ADC-heavy sequencing expands in later lines,
   • payers emphasize value-based contracting,
   • biosimilars reduce overall spend in trastuzumab-containing regimens, which can reallocate budget within HER2 combinations.

Projection call (directional)

• Revenue trajectory: likely growth-to-plateau then gradual erosion pattern as market maturity meets pricing pressure and competitive sequencing changes.
• Volume trajectory: stable-to-slightly positive, assuming HER2 testing remains high and guidelines maintain combination use in eligible cohorts.
• Price trajectory: downward pressure from market access dynamics and companion-trastuzumab biosimilars, with pertuzumab capturing less of total regimen budget over time.

Because pertuzumab is an antibody class product with established standards, the key variable is not “replacement,” it is net regimen budget share under payer pressure and evolving sequencing toward ADCs.

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What do the labels and trial outcomes imply for payer adoption?

Two trial-backed clinical claims anchor payer adoption:

• Metastatic setting: benefit from adding pertuzumab to trastuzumab + chemotherapy established survival improvements (CLEOPATRA). [1]
• Adjuvant setting: improved invasive disease-free survival in node-positive and other higher-risk early-stage patients (APHINITY). [2]

Payers tend to sustain coverage where trials show durable outcomes (OS/IDFS) and where clinical pathways are guideline-driven. As a result, pertuzumab is likely to remain covered for its label-defined populations even as later-line ADC use rises.

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What is the investment-grade view: risk and upside?

Main upside levers

• Better identification of “most responsive” subgroups within label boundaries, supporting higher persistence and fewer treatment deferrals.
• Expanded uptake in regions where HER2 testing is still scaling, supporting incremental volume.

Main downside levers

• Further shift of metastatic sequencing to ADCs that reduce downstream retention of trastuzumab-based platforms.
• Continued pricing compression via contracting, discounting, and biosimilar spillover effects for companion trastuzumab.

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Key Takeaways

• PERJETA (pertuzumab) is clinically anchored by CLEOPATRA (metastatic OS/PFS benefit) and APHINITY (adjuvant IDFS benefit in higher-risk early-stage patients). [1], [2]
• The market is mature with demand resilience in earlier lines and budget pressure from pricing dynamics and later-line ADC sequencing.
• The base case is stability to plateau with gradual erosion in revenue growth rate as competitive and payer forces tighten net prices, while volume depends on HER2 testing and guideline adherence.

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FAQs

1. What regimen is PERJETA most associated with clinically?
   Pertuzumab is used with trastuzumab and chemotherapy in both metastatic and adjuvant HER2-positive breast cancer settings, based on phase 3 evidence. [1], [2]

2. Which trials underpin PERJETA’s current adoption?
   CLEOPATRA for metastatic disease and APHINITY for adjuvant high-risk early-stage disease. [1], [2]

3. How do HER2 ADCs affect PERJETA demand?
   ADCs primarily influence later-line sequencing, which can reduce share in downstream therapy, but do not fully remove pertuzumab’s early-line role established in OS/IDFS-improving combinations.

4. What is the biggest commercial risk for PERJETA?
   Net pricing pressure from payer contracting and regimen budget reallocation, compounded by competition and biosimilar spillover on companion trastuzumab.

5. What is the biggest commercial driver?
   HER2 testing penetration and guideline adherence that keep pertuzumab in early treatment settings for eligible patients.

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References (APA)

[1] Swain, S. M., Baselga, J., Kim, S. B., Ro, J., Semiglazov, V., Smith, M., … Han, J. M. (2013). Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. The New England Journal of Medicine, 368(14), 1225-1233.
[2] von Minckwitz, G., Procter, M., de Azambuja, E., et al. (2017). Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. The New England Journal of Medicine, 377(2), 122-131.