RPCEC00000057已完成1 期
Advanced breast cancer treatment with hR3 monoclonal antibody combined with doxorubicin and cyclophosphamide. Clinical trial, phase I.
Center of Molecular Immunology (CIM)0 个研究点目标入组 15 人开始时间: 2010年12月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Other. Purpose: Treatment
入排标准
- 年龄范围
- 19 years 至 one（—）
- 性别
- Female
入选标准
- •1)Female patients with histologically confirmed breast cancer. 2)Patients with breast cancer, stage III or IV. 3)Patients should not have been on oncological treatment in the last 4 weeks prior to this treatment. 4)Age >18. Children are not included in the study because there are no data available in connection with adverse events and hR3 MaB dosage combined with doxorubicin and cyclophosphamide in patients under 18 years of age. 5)General condition ECOG <2 (Karnofsky >60%). 6)Life expectancy over 6 months. 7)Patient’s organs and bone marrow should be working normally, as defined by the following parameters: leucocytes >3,000/ul, absolute neutrophil count >1,500/ul, platelets >100,000/ul, total bilirubin within normal limits, TGO/TGP 60 mL/min/1.73 m2 on patients with creatinine values higher than the normal values established by the institution. 8)Patients with HER1+tumors (EGF positive receptor) determined by immunohistochemical techniques. 9)The effect of hR3 monoclonal antibody on human fetuses under development is unknown. Considering this and the fact that chemotherapy can also be teratogenic, reproductive age women should use appropriate contraceptive methods (barrier, hormone or abstinence) before and during the clinical trial. Reproductive age female patients should also be pregnancy-tested negative. If a patient gets pregnant or believes she is pregnant, she should inform her doctor immediately. 10)Capacity to understand the study and readiness to sign the informed consent document.
排除标准
- •1) Patients on another product under research. 2) Patients with history of allergy attributed to chemical or biological compounds similar to hR3 monoclonal antibody or the chemotherapy used in the study. 3) Patients with uncontrolled intercurrent diseases, including active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric or social diseases hindering adherence to clinical trial requirements. 4) Pregnant patients. 5) Breastfeeding should be discontinued upon inclusion in the clinical trial because of potential and unknown adverse effects on infants. 6) Patients with anthracycline contraindications. 7) Patients with brain metastasis.
研究者
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