Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT05346224

PHASE3

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

Sponsor: Shanghai Henlius Biotech

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2022-04-25

Completion Date

2025-12-30

Last Updated

2025-06-10

Healthy Volunteers

Conditions

Breast Cancer Breast Neoplasms HER2-positive Breast Cancer

Interventions

DRUG

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

DRUG

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

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).

Locations (79)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (79)