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Breast CancerPhase 3NCT05346224

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

A Phase 3 study testing HLX11 and EU-Perjeta® in people with Breast Cancer and Breast Neoplasms, run by Shanghai Henlius Biotech at 79 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HLX11 and EU-Perjeta®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
79 sitesin 4 countries
Study dates
25 Apr 2022to 30 Dec 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Primary breast cancer that is:
  • Histologically confirmed invasive breast carcinoma with a primary tumor size of > 2 cm by standard local assessment technique;
  • 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);
  • HER2 positive confirmed by central laboratory, defined as immunohistochemistry (IHC) 3 +, or IHC 2+ and In Situ Hybridization (ISH) positive;
  • 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.

Who cannot join

  • Inflammatory breast cancer.
  • Stage IV (metastatic) breast cancer, bilateral breast cancer, or multicentric (multiple tumors involving more than 1 quadrant) breast cancer.
  • 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 ).
  • 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).

Trial locations and contacts

79 sites in 4 countries.

79 sites in 4 countries

China75 sites

  • Anyang Cancer Hospital

    Anyang, Henan, 455100

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

  • the First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • Cangzhou Central Hospital

    Cangzhou, Hebei

  • The first hospital of Jilin University

    Changchun, JIilin

  • Xiangya Hospital Of Central South University

    Changsha, Hunan, 410008

  • The Second Xiangya Hospital Of Central South University

    Changsha, Hunan, 410011

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuang, 610072

  • he First Affiliated Hospital of Chongqing Medical University

    Chongqi, Chongqing Municipality

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

  • The second hospital of dalian medical university

    Dalian, Liaoning

  • People's hospital of Deyang city

    Deyang, Sichuang, 618000

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350000

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong, 510095

  • Sun Yat-Sun Yat-sen Hospital affiliated to Sun Yat-sen Universitysen Hospital affiliated to Sun Yat-sen University

    Guanzhou, Guangdong

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • Affiliated Tumor Hospital of Guizhou Medical University

    Guiyang, Guzhou

  • The First Affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang, 310000

  • The Second Affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang, 310000

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310000

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230000

  • The first affiliated hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • The first affiliated hospital of USTC (Anhui Provincial Hospital)

    Hefei, Anhui, 230036

  • Jieyang People's Hospital

    Jieyang, Guangdong

  • Shandong Provincial Hospital

    Jinan, Shangdong, 250000

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650116

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • Liaocheng People's Hospital

    Liaocheng, Shangdong, 252000

  • Lu'an people's hospital of Anhui ProvinceLuan

    Lu'an, Anhui, 237000

  • The First Affiliated Hospital of Henan University of science and Technology

    Luoyang, Henan

  • Maanshan People's Hospital

    Ma’anshan, Anhui

  • Meizhou People's Hospital

    Meizhou, Guangdong

  • Mianyang Central Hospital

    Mianyang, Sichuang

  • Nanchang Third Hospital

    Nanchang, Jiangxi, 330038

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210000

  • The First Affiliated Hospital With Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530012

  • Nantong Tumor Hospital

    Nantong, Jiangsu

  • Nanyang Central Hospital

    Nanyang, Henan

  • The second people's hospital of neijiang

    Neijiang, Sichuang, 641099

  • he Affiliated Hospital of Qingdao University

    Qingdao, Shangdong, 266000

  • Qingdao Central Hospital

    Qingdao, Shangdong, 266042

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515000

  • Shantou Central Hospital

    Shantou, Guangdong, 515000

  • Yue Bei People's Hospital

    Shaoguan, Guangdong

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi

  • Tangshan People's Hospital

    Tangshan, Hebei

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

  • Weifang People's Hospital

    Weifang, Shangdong, 261000

  • Weifang Hospital of traditional Chinese Medicine

    Weifang, Shangdong

  • Weihai Municipal Hospital

    Weihai, Shangdong

  • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • Yijishan Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

  • affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu

  • Shaanxi Provincial People's Hospital

    Xi’an, Shanxi

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361000

  • The First Affiliated Hospital of Xi'an JiaoTong University

    Xian, Shanxi

  • The First Affiliated Hospital of the Xinxiang Medical University

    Xinxiang, Henan

  • Xinxiang Central Hospital

    Xinxiang, Henan

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

  • Yantai Yuhuangding Hospital

    Yantai, Shangdong

  • The second people's hospital of Yibin

    Yibin, Sichuang, 644000

  • Yuncheng Central Hospital

    Yuncheng, Shanxi

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • The Third Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • Zhongshan People's Hospital

    Zhongshan, Guangdong

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000

Other trials in China

Spain2 sites

  • Hospital Arnau de Vilanova de Lleida

    Barcelona, Catalonia

  • Hospital Clínico Universitario de Santiago de Compostela (CHUS)

    Santiago de Compostela, A Coruna

Other trials in Spain

Hungary1 site

  • University of Pécs, Department of Oncotherapy

    Pécs, Baranya

Other trials in Hungary

Poland1 site

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, Łódź Voivodeship

Other trials in Poland

About this study

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

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.

Read the detailed description

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.Subjects will be randomly assigned to treatment group (HLX11) or control group (EU-Perjeta®) at 1:1 ratio. The stratification factors include disease category (early-stage vs. locally advanced) and geographic region (Asia vs. non-Asia).

Study drugs will be administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence trastuzumab, followed by pertuzumab and docetaxel(THP regimen) for neoadjuvant，Doxorubicin in combination with cyclophosphamide (AC) for adjuvant chemotherapy, then HP regimen for adjuvant HER2-targeted.

The primary endpoint is total pCR (tpCR) . Secondary efficacy endpoints include breast pCR (bpCR), objective response rate (ORR),Event-free survival (EFS) and Disease-free survival (DFS).

The safety indicators is incidence, type, severity, and causality of all adverse events (including serious adverse events and AESI) based on NCI CTCAE v5.0; Vital signs, physical examination, laboratory tests, cardiac function test, etc.

pharmacokinetic(PK) and immunogenicity is also assessed.

Being tested
HLX11, EU-Perjeta®
Keywords
Perjeta, Pertuzumab, early-stage, locally Advanced, neoadjuvant, adjuvant
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX11Drug

    Also called Recombinant anti-HER2 domain II humanized monoclonal antibody injection

    Neoadjuvant(q3w/cycle，total 4cycle): HLX11(loading dose of 840 mg IV , followed by 420 mg IV q3w)+trastuzumab(loading dose of 8 mg/kg IV, followed by 6mg/kg IV q3w)+docetaxel(75mg/m2 IV q3w) Adjuvant: doxorubicin( 60 mg/m2 IV q3w)+cyclophosphamide( 600 mg/m2 IV q3w),total 4 cycle; trastuzumab(loading dose of 8mg/m2 IV , followed by 6 mg/m2 IV q3w)+HLX11(loading dose of 840 mg IV , followed by 420 mg IV q3w), 13cycle

  • EU-Perjeta®Drug

    Neoadjuvant(q3w/cycle，total 4cycle): Perjeta (loading dose of 840 mg IV , followed by 420 mg IV q3w)+trastuzumab(loading dose of 8 mg/kg IV, followed by 6mg/kg IV q3w)+docetaxel(75mg/m2 IV q3w) Adjuvant: doxorubicin( 60 mg/m2 IV q3w)+cyclophosphamide( 600 mg/m2 IV q3w),total 4 cycle; trastuzumab(loading dose of 8mg/m2 IV , followed by 6 mg/m2 IV q3w)+HLX11 or Perjeta (loading dose of 840 mg IV , followed by 420 mg IV q3w), 13cycle

Study groups in NCT05346224
Study groupRoleWhat they receive
Treatment groupExperimentalHLX11 combined with trastuzumab and docetaxel will be adopted in the neoadjuvant treatment phase, and doxorubicin with cyclophosphamide will be administered in the adjuvant chemotherapy treatment phase, HLX11 combined with trastuzumab will be administered in the adjuvant treatment phase for HER-2 targeted.
Receives: Drug: HLX11
Control groupActive comparatorPerjeta combined with trastuzumab and docetaxel will be adopted in the neoadjuvant treatment phase, and doxorubicin with cyclophosphamide will be administered in the adjuvant chemotherapy treatment phase, HLX11 or Perjeta combined with trastuzumab will be administered in the adjuvant treatment phase for HER-2 targeted.
Receives: Drug: EU-Perjeta®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The total pathological complete response (tpCR) rate assessed by the Independent Review Committee (IRC)

    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)

    Measured: immediately after the surgery

Secondary outcomes (1)

  1. Breast pathologic complete response (bpCR) rate

    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)

    Measured: immediately after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2022
  2. Study start25 Apr 2022
  3. Primary completion15 May 2024
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel-Controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05346224
Sponsor's protocol ID
HLX11-BC301
Status last verified
Jun 2025
First submitted
17 Apr 2022
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yang J, Lin L, Long Q, Zhang Q, Sun G, Zhou L, Wang Q, Zhu J, Li F, Hu W. HLX11, a Proposed Pertuzumab Biosimilar: Pharmacokinetics, Immunogenicity, and Safety Profiles Compared to Three Reference Biologic Products (US-, EU-, and CN-Approved Pertuzumab) Administered to Healthy Male Subjects. BioDrugs. 2022 May;36(3):393-409. doi: 10.1007/s40259-022-00534-w. Epub 2022 May 20.

    PubMed 35594017

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HLX11 and EU-Perjeta® in people with Breast Cancer and Breast Neoplasms, run by Shanghai Henlius Biotech at 79 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in China, Spain, Hungary, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The total pathological complete response (tpCR) rate assessed by the Independent Review Committee (IRC) (time frame: immediately after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05346224, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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