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 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
1 other identifier
interventional
900
4 countries
79
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Apr 2022
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2022
CompletedStudy Start
First participant enrolled
April 25, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedJune 10, 2025
June 1, 2025
2.1 years
April 17, 2022
June 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
immediately after the surgery
Secondary Outcomes (1)
Breast pathologic complete response (bpCR) rate
immediately after the surgery
Study Arms (2)
Treatment group
EXPERIMENTALHLX11 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.
Control group
ACTIVE 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.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- \. 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.
- \. Left ventricular ejection fraction (LVEF) at baseline (within 42 days prior to randomization) ≥ 55% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan.
- \. 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.
- \. 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.
You may not qualify if:
- 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:
- \) 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (79)
the First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
The first affiliated hospital of Anhui Medical University
Hefei, Anhui, 230022, China
The first affiliated hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, 230036, China
Lu'an people's hospital of Anhui ProvinceLuan
Lu'an, Anhui, 237000, China
Maanshan People's Hospital
Ma’anshan, Anhui, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
he First Affiliated Hospital of Chongqing Medical University
Chongqi, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350000, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510095, China
Sun Yat-Sun Yat-sen Hospital affiliated to Sun Yat-sen Universitysen Hospital affiliated to Sun Yat-sen University
Guanzhou, Guangdong, China
Jieyang People's Hospital
Jieyang, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515000, China
Shantou Central Hospital
Shantou, Guangdong, 515000, China
Yue Bei People's Hospital
Shaoguan, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Zhongshan People's Hospital
Zhongshan, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530012, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
Affiliated Tumor Hospital of Guizhou Medical University
Guiyang, Guzhou, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Tangshan People's Hospital
Tangshan, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Anyang Cancer Hospital
Anyang, Henan, 455100, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
The First Affiliated Hospital of the Xinxiang Medical University
Xinxiang, Henan, China
Xinxiang Central Hospital
Xinxiang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Xiangya Hospital Of Central South University
Changsha, Hunan, 410008, China
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, 410011, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000, China
The First Affiliated Hospital With Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
Nanchang Third Hospital
Nanchang, Jiangxi, 330038, China
The first hospital of Jilin University
Changchun, JIilin, China
The second hospital of dalian medical university
Dalian, Liaoning, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Shandong Provincial Hospital
Jinan, Shangdong, 250000, China
Liaocheng People's Hospital
Liaocheng, Shangdong, 252000, China
he Affiliated Hospital of Qingdao University
Qingdao, Shangdong, 266000, China
Qingdao Central Hospital
Qingdao, Shangdong, 266042, China
Weifang People's Hospital
Weifang, Shangdong, 261000, China
Weifang Hospital of traditional Chinese Medicine
Weifang, Shangdong, China
Weihai Municipal Hospital
Weihai, Shangdong, China
Yantai Yuhuangding Hospital
Yantai, Shangdong, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an JiaoTong University
Xian, Shanxi, China
Shaanxi Provincial People's Hospital
Xi’an, Shanxi, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuang, 610072, China
People's hospital of Deyang city
Deyang, Sichuang, 618000, China
Mianyang Central Hospital
Mianyang, Sichuang, China
The second people's hospital of neijiang
Neijiang, Sichuang, 641099, China
The second people's hospital of Yibin
Yibin, Sichuang, 644000, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650116, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310000, China
The Second Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310000, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000, China
University of Pécs, Department of Oncotherapy
Pécs, Baranya, Hungary
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, Poland
Hospital Clínico Universitario de Santiago de Compostela (CHUS)
Santiago de Compostela, A Coruna, Spain
Hospital Arnau de Vilanova de Lleida
Barcelona, Catalonia, Spain
Related Publications (1)
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.
PMID: 35594017RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2022
First Posted
April 26, 2022
Study Start
April 25, 2022
Primary Completion
May 15, 2024
Study Completion
December 30, 2025
Last Updated
June 10, 2025
Record last verified: 2025-06