None listed
Conditions
Interventions
Drug : Subjects assigned to the test group according to random assignment shall administer the test drug MYJ1633 once a day, five times every two weeks, and the chemotherapy (Pertuzumab + Trastuzumab
Sponsors
Immunisbio
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Adult women over 19 years of age 2) Whether or not the hormone receptor ER (Estrogen Recorder) and PR (Progesterone Recorder) of breast cancer are expressed; 3) Silver-enhanced In Situ Hybridization (SISH) or Fluorescent in Situ Hybridization (FISH) has been confirmed to be amplified by Hump for confirmation of HER-2/neu gene expression in breast cancer, corresponding to 3+ or 2+ in Immunohistochemistry (IHC). 4) Patients with local progressive or metastatic breast cancer who cannot be resected due to recurrence. 5) Patients who can verify their history with records within the last six months 6) Left Ventricular Ejection Fraction (LVEF) = 55 percent 7) Eastern Cooperative Oncology Group (ECOG) 0-1 (ECOG performance status 2 is only allowed if bone weakness is caused) 8) A person who meets the following criteria with appropriate haematological, liver and kidney functions: (1) Absolute positive coefficient = 1,500 cells/mm3 (2) platelets = 100,000/uL, blood pigments = 8.0 g/dL (3) serum creatinine = 1.5 mg/dL (4) Blood serum bilirubin 1.5 1.5 times the normal range maximum (5) ASpartate aminoTransferase (AST)/ALanine aminoTransferase (ALT) = 3 times the normal range maximum (6) C-Reactive Protein (CRP) = 5 mg/L 9) A person whose voice has been confirmed in the urine human chorionic gondotropin (HCG) test prior to the registration of the test, if she is a fertile woman. 10) A person who voluntarily agrees to use proper contraception. 11) A person who voluntarily signed a written consent form 12) A person who agrees to take blood for tissue testing and preparation of test medications.
Exclusion criteria
Exclusion criteria: 1) Patients with positive hepatitis Immunodeficiency Virus (HIV), Hepatis B Virus (HBV), Hepatis C Virus (HCV), and Syphilis positive within four weeks before registering the subject. 2) A person who administered whole-body chemotherapy or clinical trial medication four weeks ago as of the commencement date of administering the test medication. 3) A person who has been vaccinated within four weeks or needs to be injected with a vaccine during clinical trials. 4) Patients with different immunotherapy within 6 months 5) Patients with serious medical or psychiatric diseases including patients with active heart disease (New York Heart Association (NYHA) class III, heart failure of IV, coronary artery disease such as myocardial infarction, angina, etc., or difficulty breathing in stable condition) 6) Patients with severe liver disorders, neuropathy, and reduced bone marrow function 7) Patients with organ transplants including bone marrow or hematopoietic stem cell transplants before 8) Pregnant or likely pregnant and breast-feeding patients 9) Drug administration taboo patient (1) Patients who are known to be severely hypersensitive to the composition of clinical trials or clinical trials drugs; (2) Patients with hypersensitive history in the composition of trastuzumab, rodent-derived proteins or these drugs; (3) Patients who need breathing difficulties or oxygen supplementation when serious or stable due to progressive malignant tumors (4) Patients with severe hypersensitive history of polysorbate 80. (5) Patients with epileptic pulmonary edema or pulmonary fibrosis. (6) Patients with edema 10) A person who is deemed unfit for clinical testing based on the judgment of the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Treatment-Emergent Adverse Event | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate, DCR;Immunogenic reaction (IFN-?, TNF-a);Tumor marker test (CEA,CA 15-3);Quality of life;Disease Control Rate, DCR | — |
Countries
Korea, Republic of
Contacts
Public Contactilkyun lee
Immunisbio
Outcome results
None listed