Safety and Efficacy of Irreversible Electroporation (IRE) for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
研究概览
简要总结
This trial is studying how well Irreversible Electroportion (IRE) therapy works in treating patients with breast cancer. IRE kills tumor cells by Electrical impulses creating nano-pore on the cell membrane and inducing target cell death.This may be an effective treatment for patients with unresectable breast cancer.
详细描述
This is a phase I/II non-randomized exploratory study. All fully eligible and registered patients will undergo imaging by mammography, ultrasound, and breast MRI. The primary and secondary objectives of the study are described below.
OBJECTIVES
Primary
Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
secondary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women 18 years or older with unresectable breast cancer, not amenable/willing to adenomammectomy.
- •breast carcinoma diagnosed by core needle biopsy.
- •Any menopausal status.
- •No history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/treatment of the index breast cancer.
- •Tumor size ≤ 5.0 cm in greatest diameter. Largest size measured by required scans (mammogram, ultrasound and MRI) will be used to determine eligibility.
- •Tumor enhancement on pre-study MRI.
- •Tumor with < 25% intraductal components in the aggregate.
- •Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy,
- •Non-pregnant and non-lactating. Patients of childbearing potential must have a negative serum or urine pregnancy test.
- •Adequate breast size for safe IRE. Male breast cancer patients and female breast cancer patients with breasts too small to allow safe IRE are not eligible as the minimal thickness of the breast tissue does not lend itself to IRE. NOTE: For patients with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion will not contact or jeopardize the implant.
- •Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
- •Patient must agree to provide tumor tissue from metastatic tissue at baseline.
排除标准
- •Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive DCIS.
- •History of rotational vacuum assisted core biopsies, en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
- •Prior or planned neoadjuvant chemotherapy for breast cancer.
- •Patients with thrombocytopenia and or any other coagulation abnormality
结局指标
主要结局
Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
时间窗: 3 months post treatment to 24 months
次要结局
- Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.(1 day post treatment to 3 weeks)