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> Record changed: 2026-11-04

# 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

NCT05346224

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

Recruitment status

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

Participants

900

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

Lead sponsor

Shanghai Henlius Biotech

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

Start date

2022-04-25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

Number of sites

79

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

## Title and summary

**Summary**

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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Official title**

A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Recruitment status**

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

## Dates

**Completion date**

2025-12-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**First posted**

2022-04-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Registry last updated**

2025-06-10

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Primary completion date**

2024-05-15

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Start date**

2022-04-25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

## Size and sites

**Participants**

900

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Planned participants**

900

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Protocol amendments**

3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Randomisation ratio**

1:1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Number of sites**

79

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Lead sponsor**

Shanghai Henlius Biotech

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

## Identifiers

**Registry ID**

NCT05346224

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**ClinicalTrials.gov ID**

NCT05346224

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Quadruple masking

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

## Outcomes

### Primary outcomes

1. The total pathological complete response (tpCR) rate assessed by the Independent Review Committee (IRC)  
Timeframe: immediately after the surgery  
tpCR is defined as the histological evidence of no malignancy of lymph nodes in the regions of primary lesion and metastasis of breast cancer (i.e., ypT0/is, ypN0 in accordance with the AJCC staging system)

### Secondary outcomes

1. Breast pathologic complete response (bpCR) rate  
Timeframe: immediately after the surgery  
bpCR is defined as the histological evidence of no malignancy in the primary lesion of breast cancer, or only carcinoma in situ (i.e., ypT0/Tis in the AJCC staging system, 8th edition)

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

No

### Inclusion criteria

1\. Primary breast cancer that is:

1. Histologically confirmed invasive breast carcinoma with a primary tumor size of > 2 cm by standard local assessment technique;
2. Breast cancer staging ( in accordance with the American Joint Commitee on Cancer(AJCC) staging system (8th edition)): early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0);
3. HER2 positive confirmed by central laboratory, defined as immunohistochemistry (IHC) 3 +, or IHC 2+ and In Situ Hybridization (ISH) positive;
4. Hormone receptor (HR, including estrogen receptor \[ER\] and progestin receptor \[PR\]) negative by central laboratory; ER negative is defined as < 1% nuclear staining, and PR negative is defined as < 1% nuclear staining.

2\. Left ventricular ejection fraction (LVEF) at baseline (within 42 days prior to randomization) ≥ 55% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan.

3\. Adequate major organ function, meeting the following criteria: Hematology (neither blood transfusion nor correction with hematopoietic stimulating factors within 14 days prior to randomization): white blood cell count ≥ 3.0 × 109/L; absolute neutrophil count ≥ 1.5 × 109/L; hemoglobin ≥ 90 g/L; platelet count ≥ 100 × 109/L; Serum chemistry: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN; for subjects with known Gilbert syndrome, total bilirubin ≤ 2 × ULN; alkaline phosphatase ≤ 2.5 × ULN, serum creatinine ≤ 1.5 × ULN.

4\. Women of child-bearing potential have a negative result of serum pregnancy test at screening (within 7 days prior to randomization) and not in lactation, or are infertile. Male participants and women of childbearing potential use a "highly effective" contraceptive measures until 7 months after the last dose of investigational/reference product.

### Exclusion criteria

1. Inflammatory breast cancer.
2. Stage IV (metastatic) breast cancer, bilateral breast cancer, or multicentric (multiple tumors involving more than 1 quadrant) breast cancer.
3. History of other malignancy within 5 years prior to screening (except for who have received radical treatment of carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin ).
4. With serious heart disease or medical history, including but not limited to the following conditions:

1) History of documented heart failure or systolic dysfunction with any NYHA classification(LVEF < 50%); 2) High-risk uncontrolled arrhythmia, such as atrial tachycardia with a heart rate> 100 bpm at rest, significant ventricular arrhythmia (e.g.,ventricular tachycardia), or higher-grade atrioventricular (AV) block (i.e.,Mobitz II second-degree AV block or third degree AV block); 3) Unstable angina pectoris, or angina pectoris requiring anti-angina medication; 4) Evidence of transmural myocardial infarction on ECG; 5) Clinically-significant valvular heart disease; 6) Poorly controlled hypertension (systolic blood pressure> 150 mmHg and/or diastolic blood pressure> 100 mmHg).

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

## Sites

- the First Affiliated Hospital of Bengbu Medical CollegeBengbu, China
- The Second Hospital of Anhui Medical UniversityHefei, China
- The first affiliated hospital of Anhui Medical UniversityHefei, China
- The first affiliated hospital of USTC (Anhui Provincial Hospital)Hefei, China
- Lu'an people's hospital of Anhui ProvinceLuanLu'an, China
- Maanshan People's HospitalMa’anshan, China
- Yijishan Hospital of Wannan Medical CollegeWuhu, China
- Beijing Cancer HospitalBeijing, China
- Chongqing University Cancer HospitalChongqing, China
- he First Affiliated Hospital of Chongqing Medical UniversityChongqi, China
- Fujian Cancer HospitalFuzhou, China
- The First Affiliated Hospital of Xiamen UniversityXiamen, China
- Affiliated Cancer Hospital and Institute of Guangzhou Medical UniversityGuangzhou, China
- Sun Yat-Sun Yat-sen Hospital affiliated to Sun Yat-sen Universitysen Hospital affiliated to Sun Yat-sen UniversityGuanzhou, China
- Jieyang People's HospitalJieyang, China
- Meizhou People's HospitalMeizhou, China
- Cancer Hospital of Shantou University Medical CollegeShantou, China
- Shantou Central HospitalShantou, China
- Yue Bei People's HospitalShaoguan, China
- Affiliated Hospital of Guangdong Medical UniversityZhanjiang, China
- Zhongshan People's HospitalZhongshan, China
- Guangxi Medical University Affiliated Tumor HospitalNanning, China
- Affiliated Hospital of Guizhou Medical UniversityGuiyang, China
- Affiliated Hospital of Zunyi Medical UniversityZunyi, China
- Affiliated Tumor Hospital of Guizhou Medical UniversityGuiyang, China

And 54 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

## References

- PubMed 35594017  
Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/35594017/)
Results

- Related resource (www.ncbi.nlm.nih.gov)  
Source: [www.ncbi.nlm.nih.gov](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9148872/)

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346224)

## Related records

### Drugs (1)

- [Pertuzumab](https://trialight.com/data/asset/pertuzumab-7def4e95-509d-4b35-aeb9-a153ec48056d.md)

### Lead sponsors (1)

- [Shanghai Henlius Biotech](https://trialight.com/data/company/shanghai-henlius-biotech-aec8d786-7c6e-4c63-86f6-2a3a648aa0f1.md)

### Conditions (3)

- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition
- [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md)
- [HER2 positive breast carcinoma](https://trialight.com/data/condition/her2-positive-breast-carcinoma-eb8493ec-908e-5435-bf56-0d20c0c9bb88.md)

### Targets (1)

- [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md)

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