KCT0005812招募中未知
Double-arm, Open, Parallel Assignment, Sponsor-Initiated Trial to Evaluate the Safety and Efficacy of Pertuzumab Plus Trastuzumab Plus Docetaxel Combination with MYJ1633 (Autologous Blood-Derived Lymphocytes) in Recurrent Nonresectable or Metastatic HER-2 Positive Breast Cancer Patients
Immunisbio0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 o Limit（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
研究者
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