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
NCT ID: NCT05346224
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
900 participants
INTERVENTIONAL
2022-04-25
2025-12-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment group
HLX11 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.
HLX11
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
Control group
Perjeta 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.
EU-Perjeta®
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
Interventions
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HLX11
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®
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Shanghai Henlius Biotech
INDUSTRY
Responsible Party
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Locations
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the First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
The first affiliated hospital of Anhui Medical University
Hefei, Anhui, China
The first affiliated hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China
Lu'an people's hospital of Anhui ProvinceLuan
Lu'an, Anhui, China
Maanshan People's Hospital
Ma’anshan, Anhui, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 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, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, 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, China
Shantou Central Hospital
Shantou, Guangdong, 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, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 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, 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, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xiangya Hospital Of Central South University
Changsha, Hunan, China
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital With Nanjing Medical University
Nanjing, Jiangsu, 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, China
Nanchang Third Hospital
Nanchang, Jiangxi, 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, China
Liaocheng People's Hospital
Liaocheng, Shangdong, China
he Affiliated Hospital of Qingdao University
Qingdao, Shangdong, China
Qingdao Central Hospital
Qingdao, Shangdong, China
Weifang People's Hospital
Weifang, Shangdong, 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, China
People's hospital of Deyang city
Deyang, Sichuang, China
Mianyang Central Hospital
Mianyang, Sichuang, China
The second people's hospital of neijiang
Neijiang, Sichuang, China
The second people's hospital of Yibin
Yibin, Sichuang, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 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
Countries
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References
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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.
Related Links
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Results from this study demonstrated the bioequivalence between HLX11 and US-, EU-, and CN-pertuzumab, supporting further investigation of HLX11 in clinical studies
Other Identifiers
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HLX11-BC301
Identifier Type: -
Identifier Source: org_study_id
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