Breast cancer
Conditions
Interventions
HS627:Once given
Sponsors
The Fifth Medical Center of PLA General Hospital (South Hospital)
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female, age >= 18 years old and = 7; 8. Patients with an expected survival time of at least 12 weeks; 9. Patients who voluntarily sign the informed consent form, understand the nature, purpose and procedure of the trial and voluntarily comply with the test requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who have been previously allergic to trastuzumab or known to be allergic to any component or excipient of the test drug; 2. Patients with other malignant tumors in the past 5 years, excluding those with cured cervical carcinoma in situ, basal cell carcinoma or squamous cell skin cancer; 3. Patients with any of the following heart diseases: (1) At present, he has untreated or uncontrollable hypertension (systolic blood pressure > 150 mmHg and / or diastolic blood pressure > 100 mmHg) or unstable angina pectoris; (2) According to the New York Heart Association (NYHA) classification criteria, patients with any grade of congestive heart failure history, or serious arrhythmias requiring treatment (except atrial fibrillation or paroxysmal supraventricular tachycardia); (3) The history of myocardial infarction within 6 months before signing the informed consent form; (4) LVEF decreased to less than 50% during or after previous adjuvant therapy with trastuzumab; 4. Patients with serious and uncontrollable systemic diseases and symptoms (such as cardiovascular system, respiratory system, metabolic system disease, ulcer, fracture and dyspnea, etc.) will significantly increase the risk of subjects participating in / completing the trial according to the judgment of researchers; 5. Patients who had been treated with patuzumab within 6 months before signing the informed consent form; 6. Patients who had been treated with trastuzumab within 6 months before signing the informed consent form; 7. Patients who have received lapatinib or other anti HER2 treatment within one week before signing the informed consent form; 8. Patients who had received radiotherapy within 4 weeks before signing the informed consent form; 9. Patients with positive HIV, HCV and TP antibodies, and patients with active hepatitis B detected by hepatitis B virus (HBV) surface antigen and HBV DNA; 10. Patients with abnormal laboratory examination or other abnormal laboratory examination considered by the researcher to be clinically significant (any one of which does not meet the requirements shall be excluded) (1) Peripheral blood cell count: absolute neutrophil count (ANC) = 1.5 times of upper limit of normal value, ALT and AST >= 2.5 times of upper limit of normal value; (3) Renal function: serum creatinine (CR), urea nitrogen (BUN) >= 1.5 times the upper limit of normal value; or creatinine clearance rate (CCR) = 200 ms, QRS >= 110 ms, QTc >= 460 ms or ECG abnormalities with clinical significance judged by researchers; 11. In addition to the above abnormal laboratory tests, other acute toxicity reactions of previous treatment have not recovered. According to NCI CTCAE 4.03 standard, patients with grade 2 or above toxicity reactions (excluding hair loss) have not been cured; 12. Patients with related diseases affecting intravenous injection and venous blood collection in the past; 13. Patients who have received any antibody or fusion protein drugs within 6 months before signing the informed consent form; 14. Patients who have been vaccinated within 3 months before signing the informed consent form or intend to be vaccinated during the study period; 15. Patients who have blood donation history w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence and frequency of AE, SAE and DLT;MTD (if any), clinical recommended dosage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic indicators: including but not limited to AUC0-last, AUC0-8, Cmax, Tmax, t and CL/F; | — |
Countries
China
Contacts
Public ContactZefei Jiang
Affiliated Hospital of Academy of Military Medical Sciences
Outcome results
None listed