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    Summary
    EudraCT Number:2022-002189-34
    Sponsor's Protocol Code Number:HLX11-BC301
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-08-17
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2022-002189-34
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.
    A.4.1Sponsor's protocol code numberHLX11-BC301
    A.5.4Other Identifiers
    Name:China clinical trial registration Number:CTR20220391
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShanghai Henlius Biotech, Inc.
    B.1.3.4CountryChina
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportShanghai Henlius Biotech, Inc.
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShanghai Henlius Biotech, Inc.
    B.5.2Functional name of contact pointJin Li
    B.5.3 Address:
    B.5.3.1Street AddressRoom 330, Complex Building, No. 222, Kangnan Road
    B.5.3.2Town/ city(Shanghai) Pilot Free Trade Zone
    B.5.3.3Post code200120
    B.5.3.4CountryChina
    B.5.4Telephone number+8613816730978
    B.5.6E-mailjin_li@henlius.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name Recombinant anti-HER2 domain II humanized monoclonal antibody HLX11
    D.3.2Product code HLX11
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPertuzumab
    D.3.9.1CAS number 380610-27-5
    D.3.9.3Other descriptive nameHLX DS
    D.3.9.4EV Substance CodeSUB16455MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typebiosimilar medicinal product, monoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Perjeta
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePerjeta
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPertuzumab
    D.3.9.1CAS number 380610-27-5
    D.3.9.3Other descriptive namePerjeta
    D.3.9.4EV Substance CodeSUB16455MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HER2-Positive and HR-Negative Early-stage or Locally advanced Breast Cancer
    E.1.1.1Medical condition in easily understood language
    HER2-Positive and HR-Negative Early-stage or Locally advanced Breast Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10065430
    E.1.2Term HER2 positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10083232
    E.1.2Term HER2 negative breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To prove that HLX11 and EU Perjeta® have similar clinical efficacy on HER2 positive and HR negative early stage or locally advanced breast cancer.
    E.2.2Secondary objectives of the trial
    To compare the safety, pharmacokinetics and immunogenicity of HLX11 vs. EU Perjeta®.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed Informed Consent Form;
    2. Male or female aged ≥ 18 years old at the time of signing the informed consent form;
    3. 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 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 IHC2 + and ISH positive;
    4) Hormone receptor (HR, including estrogen receptor [ER] and progesterone receptor [PR]) negative by central laboratory.
    Note: In accordance with the AJCC staging system (8th edition), ER negative is defined as < 1% nuclear staining, and PR negative is defined as < 1% nuclear staining.
    In the screening period, tumor sample that consists unstained ,freshly cut slides must be provided to the central laboratory for relevant testing according to the manual.
    4. Patients agree to undergo surgery while meeting the criteria for surgery after neoadjuvant therapy.
    5. Left ventricular ejection fraction (LVEF) at baseline (within 28 days prior to the first dose of study treatment) ≥ 55% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan.
    6. Adequate major organ function, meeting the following criteria (without blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor (CSF) therapy within 14 days prior to the first dose of study treatment):
    Hematology
    White blood cell count (WBC) ≥ 3.0 × 109/L
    Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
    Hemoglobin (Hb) ≥ 90 g/L
    Platelet count (PLT) ≥ 100 × 109/L
    Hepatic and renal function
    Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for subjects with known Gilbert syndrome, total bilirubin ≤ 2 × ULN
    Aspartate aminotransferase (AST) ≤ 2.5 × ULN
    Alanine aminotransferase (ALT) ≤ 2.5 × ULN
    Alkaline phosphatase (ALP) ≤ 2.5 × ULN
    Serum creatinine (Cr) ≤ 1.5 × ULN;
    Calculated creatinine clearance (CrCl) ≥ 50 mL/min(calculated per Cockcroft-Gault equation) for subjects with Cr > 1.5 × ULN
    Coagulation
    Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
    Prothrombin time (PT) ≤ 1.5 × ULN
    International Normalized Ratio (INR) ≤ 1.5 × ULN
    7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1 within 7 days prior to the first dose of study treatment.
    8. Women of child-bearing potential have a negative result of serum pregnancy test at screening (within 7 days prior to the first dose of study treatment) 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 administration.
    E.4Principal exclusion criteria
    1. Inflammatory breast cancer.
    2. Stage IV (metastatic) breast cancer, bilateral breast cancer, or multicentric (multiple tumors involving more than 1 quadrant separated by more than 5cm) breast cancer.
    3. History of other malignancy within 5 years prior to screening (except for who have received radical treatment of localized carcinoma such as carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, etc. ).
    4. No prior or current systemic anti-tumor therapy for this invasive breast cancer (including systemic chemotherapy, molecular targeted therapy, biological therapy, and other investigational therapies, etc.).
    5. Subjects have participated in another clinical trial within 4 weeks (in the case of a clinical trial of a monoclonal antibody drug, 3 months) prior to the enrollment, or intend to participate in another clinical trial during the period of the study.
    6. 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 pectrois, 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> 160 mmHg and/or diastolic blood pressure> 100 mmHg).
    7. History of doxorubicin exposure > 360 mg/m2 (or equivalent).
    Note: Equivalent agents include: epirubicin > 720 mg/m2, mitoxantrone > 120 mg/m2, idarubicin > 90 mg/m2, liposomal doxorubicin or other anthracyclines exceeding 360 mg/m2 doxorubicin equivalents. If more than one anthracycline is used, the cumulative dose should not exceed 360 mg/m2 doxorubicin equivalent.
    8. Subjects with viral hepatitis.
    Subjects with hepatitis B (positive for HBsAg or HBcAb and positive for HBV-DNA) or hepatitis C (positive for HCV antibody and positive for HCV-RNA), or subjects with hepatitis B and hepatitis C co-infection (positive HBsAg or HBcAb and positive HCV antibody)HbsAg (+) or HBcAb (+) should be tested for HBV-DNA.
    Note: During the screening period, HBV infected subjects who are stable after antiviral treatment (HBV-DNA≤2500 copies/mL or 500IU/mL) can be included.
    9. Human immunodeficiency virus (HIV) infection, and positive anti-HIV antibody.
    10. Sensitivity to any study medications or any of its ingredients or excipients.
    11. Subjects who underwent any major surgery (defined as surgeries requiring at least 3 weeks to recovery ) within 28 days prior to the first dose of study treatment .Or subjects who have received local radiotherapy, radiofrequency ablation, or interventional therapy (previous diagnostic biopsy is acceptable) within 2 weeks prior to the first dose.
    12. Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness.
    13. Any other conditions which are inappropriate for the study in the opinion of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The total pathological complete response (tpCR) rate will be 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).
    E.5.1.1Timepoint(s) of evaluation of this end point
    17 months
    E.5.2Secondary end point(s)
    • tpCR rate, as assessed by the investigator;
    • Breast pathologic complete response (bpCR) rate, as assessed by IRC. 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);
    • Breast pathologic complete response (bpCR) rate, as assessed by the investigator;
    • Objective response rate (ORR), as assessed by the investigator, defined as the percentage of subjects whose best overall responses are evaluated as complete response (CR) or partial response (PR) according to RECIST v1.1 criteria during the neoadjuvant treatment period;
    • Event-free survival (EFS), defined as the time of the following events recorded from randomization to the end of adjuvant therapy, whichever occurs first:
    • (Before surgery) Progressive disease (PD) as determined by the investigator (according to RECIST v1.1). Any evidence of in situ contralateral disease will not be identified as PD, and any evidence of invasive contralateral disease will be considered as PD.
    (After surgery) Disease recurrence or metastasis (local, regional, distant, or contralateral)
    Death from any cause
    • Disease-free survival (DFS), defined as the time of the following events recorded from no lesion after surgery to the end of adjuvant therapy, whichever occurs first:
    (After surgery) Disease recurrence or metastasis (local, regional, distant, or contralateral)
    Death from any cause
    E.5.2.1Timepoint(s) of evaluation of this end point
    17 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    China
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as 30 ± 5 days after the end of adjuvant therapy for the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months17
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 450
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 190
    F.4.2.2In the whole clinical trial 900
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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