EUCTR2021-000458-24-IT进行中（未招募）1 期
Pilot study on electrochemotherapy in metastatic breast cancer (BREAST ECT) - BREAST ECT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Age > 18 years
- •Diagnosis of histologically confirmed breast cancer with intraparenchymal breast lesion
- •Stability of the disease assessed at the end of three cycles of systemic therapy regardless of the type of drug according to RECIST 1.1 criteria.
- •Stage IV of the disease according to TNM (VIII AJCC classification)
- •Performance status (PS) according to (ECOG) = 2
- •Signature of informed consent
- •Patients not randomized to other clinical trials
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Carcinomatous Mastitis (IBC - T4d stage)
- •Neutrophils <1,000 / ml
- •Platelets <70,000 / mL
- •Hemoglobin = 9 gr / dl
- •Known allergy to Bleomycin
- •Cumulative dose of Bleomycin which exceeded 250 mg/m2
- •Infection in progress
- •Cardiac arrhythmia [severe conduction disorders such as type 2 and type 3 atrioventricular blocks and sino-atrial block]
- •History of Epilepsy
- •Pregnancy in progress
- •Patient unable to read or understand study documents
- •Patient with any disease or other significant clinical condition that, in the investigator's judgment, could interfere with the study assessments or with adequate participation in the study.
- •Patient in progression of the disease
研究者
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