breast cancer
Conditions
Interventions
Experimental group:Intravenous injection of HS022
Control group:Intravenous herceptin
Sponsors
Fifth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent voluntarily; 2. Female, aged 18 to 70 years old; 3. Body mass index (BMI) ranged from 20 to 28 kg/m2 (including 20 kg/m2 and 28 kg/m2), and body weight ranged from 50 to 75 kg (including 50 kg and 75 kg); 4. Histology confirmation for invasive breast cancer; 5. HER2 positive breast cancer was diagnosed by local pathological laboratory. The definition of HER2 positive includes IHC (++) or ISH positive. IHC (++) should be further detected by fluorescence in situ hybridization (FISH) or color in situ hybridization (CISH) and silver-enhanced in situ hybridization (SISH); 6. At least one month before signing the informed consent, the last medication for surgery or chemotherapy was used. 7. No recurrence or metastasis was confirmed after operation; 8. The physical state score of the Eastern Cancer Cooperative Group (ECOG) was less than or equal to 1; 9. Echocardiographic left ventricular ejection fraction (LVEF) > 50%; 10. The main organs of heart, liver and kidney are functioning normally; 11. Life expectancy is expected to be at least 3 months.
Exclusion criteria
Exclusion criteria: 1. Anaphylaxis to any ingredient or excipient of the tested drug, including benzyl alcohol, has been known in the past; 2. Other malignant tumors in the past five years, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell skin cancer; 3. A clear history of neurological or psychiatric disorders, including epilepsy or dementia; 4. Previous diseases affecting intravenous injection and venous blood collection; 5. Accept any antibodies and fusion proteins within one year before signing the informed consent; 6. Participate in other clinical trials within one month before signing the informed consent; 7. There is a history of blood donation within three months before the signing of the informed consent, or blood donation is planned during the trial period; 8. Surgery is planned during the trial period; 9. Has received anti-HER2 treatment; 10. Anti-drug antibodies (HAHAs) were positive; 11. Abnormal laboratory tests (any non-compliance should be excluded): (1) Peripheral blood cell count: white blood cell (WBC) = 3.5 *10^9/L, neutrophil absolute count (ANC) = 1.5 *10^9/L, platelet (PLT) = 100 *l0^9/L, and hemoglobin (Hb) = 90 g/L; (2) Liver function: total bilirubin (> 1.5 times normal value upper limit), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (> 2.5 times normal value upper limit); (3) Renal function: the upper limit of serum creatinine and urea nitrogen (BUN) > 1.5 times normal value; (4) Human chorionic gonadotropin (HCG) was positive at screening and baseline; 12. Any positive human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody and hepatitis C virus antibody should be excluded. HBsAg positive should be excluded, HBsAg negative, and HBsAg core antibody positive should be further tested for HBV DNA, if higher than the upper limit of reference value of hospitals, it should be excluded; 13. Researchers consider it unsuitable for enrollment or may not be able to complete the experiment for other reasons. Employees of researchers, research centers, bidders and contract research organizations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of hs022 and Herceptin ? in breast cancer patients; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity of hs022 and Herceptin ? in single dose breast cancer subjects;Safety of hs022 and Herceptin ? in single dose breast cancer subjects:; | — |
Countries
China
Contacts
Public ContactJIANG ZEFEI
the Fifth Medical Center of the General Hospital of the People's Liberation Army of China
Outcome results
None listed