HER2-Positive and HR-Negative Early-stage or Locally advanced Breast Cancer MedDRA version: 23.0 Level: PT Classification code 10065430 Term: HER2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 23.0 Level: PT Classification code 10083232 Term: HER2 negative breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Recombinant anti-HER2 domain II humanized monoclonal antibody HLX11
Product Code: HLX11
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Pertuzumab
CAS Num
Sponsors
Shanghai Henlius Biotech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 1.5 × 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. 8. Women with child-bearing potential have a negative result of serum pregnancy test at screening period(within 7days prior to the first dose). Infertile women and women who were not lactating. Men and women with childbearing potential take highly effective contraceptive measures until 7 months after investigational/reference product administration. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 900
Exclusion criteria
Exclusion criteria: 1. Inflammatory breast cancer. 2. Stage IV (metastatic) breast cancer, bilateral breast cancer, or multicentric (multiple tumors involving more than 1 quadrant with more than 5 cm interval) breast cancer. 3. History of other malignancy within 5 years prior to screening(except for those who have received radical treatment of localized carcinomas 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 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> 160mmHg 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 test for HBsAg or HBcAb and positive test for HBV-DNA) or Hepatitis C (positive tests for HCV antibody and HCV-RNA). Subjects with a co-infection of hepatitis B and hepatitis C (tested positive for HBsAg or HBcAb, and positive for anti-HCV antibody).Note: Hepatitis B subjects whose disease status are stable after antiviral treatment (HBV-DNA = 2500 copies/mL or 500 IU/mL) during the screening period can be enrolled in the study. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove that HLX11 and EU Perjeta® have similar clinical efficacy on HER2 positive and HR negative early stage or locally advanced breast cancer.;Secondary Objective: To compare the safety, pharmacokinetics and immunogenicity of HLX11 vs. EU Perjeta®.;Primary 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).;Timepoint(s) of evaluation of this end point: after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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 therapy 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;Timepoint(s) of evaluation of this end point: after surgery | — |
Countries
Brazil, Bulgaria, Hungary, Poland, Spain
Contacts
Public ContactJin Li
Shanghai Henlius Biotech, Inc.
Outcome results
None listed