Breast cancer
Conditions
Interventions
Group 1:1.2 mg/kg
Group2:2.4mg/kg
Group 3:3.6mg/kg
Group 4:4.8mg/kg
Case extension study group:Complete 2 cycles of dosing
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, both male and female; 2. Pathologically confirmed locally advanced or metastatic breast cancer with HER2 positive (HER2 positive refers to those whose immunohistochemical staining intensity is not less than 10% of the tumor cells is 2 + and confirmed by fluorescence in situ hybridization [FISH], or whose immunohistochemical staining intensity is 3 + [staining intensity range is 0-3]); 3. Standard treatment regimen is ineffective or there is no standard effective treatment regimen; 4. ECOG01; 5. Expected survival time =12 weeks; 6. The patient has at least one measurable lesion (RECIST 1.1); (This criterion is applicable only to the second stage, The presence or absence of measurable lesions in the first stage is acceptable); 7. The function of vital organs meets the laboratory requirements; 8. Patients who had previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy needed at least four weeks between the last dose and the study drug (at least six weeks if they had previously received nitrosourea or mitomycin chemotherapy or Herceptin targeted therapy); 9. Voluntary participation in this clinical trial, has signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. There is a third interstitial effusion (e.g., massive pleural effusion and ascites) that cannot be controlled by drainage or other means 2. The patients with brain tumors were diagnosed by imaging examination 3. Subjects had active infections or had fever of unknown origin > 38.5 C during screening or before the first administration of the drug. (According to the investigators, the fever caused by tumors could be enrolled in the group.) 4. Subjects had previous or concurrent primary malignant tumors (except cured skin basal cell carcinoma and cervical carcinoma in situ) 5. Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) heart failure above NYHA Level 2; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmia who need treatment or intervention; 6. Subjects with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B, hepatitis C antibody positive, or syphilis infection; 7. Subjects with peripheral neuropathy =grade 2 (based on NCI CTCAE v4.03); 8. Participated in or participating in other clinical studies within 4 weeks before starting the study of drug therapy; 9. Subjects may receive other systemic antineoplastic treatments during the study period; 10. Those with known history of allergy to the constituents of this drug; 11. Pregnant or lactating women; 12. Blood pregnancy tests were positive for women of childbearing age during screening (male and female subjects should use reliable contraceptive methods to prevent pregnancy during the trial and within 7 months after the last administration); 13. Subjects were known to have a history of psychotropic drug abuse, alcoholism or drug abuse; 14. According to the researchers'judgment, there are other factors that may lead to the forced termination of the study, such as other serious diseases (including mental disorders) requiring combined treatment, severe laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of test data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure;Pulse;Temperature;ECG;Blood Routine Examination;Routine Urine Examination;Blood Biochemical; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed