Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 6
- 主要终点
- Number of Participants With Implantable Devices
研究概览
简要总结
The purpose of this study is to test the safety and feasibility of placing and removing a small device that contains anti-cancer drugs in a breast tumor of patients who plan on having breast surgery without treatment prior or patients who plan on receiving standard preoperative chemotherapy prior to their breast surgery. This device may be able to predict what types of treatment work best against an individual's breast cancer. With this device, the investigators hope to be able to personalize treatment choices based on an individual's type of breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed invasive breast cancer that is: Triple negative (ER<10%, PR<10%, and HER2 0/1+ or 2+/FISH not amplified)
- •Tumor size 2cm or greater; N any; M0
- •Tumor size 1cm or greater; N any; M0 (Cohort 1)
- •Tumor size 2cm or greater; N any; M0 (Cohort 2)
- •Candidate for curative breast cancer surgery (Cohort 1 or 2)
- •Candidate for neoadjuvant chemotherapy with a standard of care, anthracycline-based regimen (Cohort 2 preferred over Cohort 1)
- •Age >18 years of age
- •ECOG performance status of ≤2
- •Serum or urine pregnancy test negative within 2 weeks for women of childbearing potential.
- •Willing and able to provide informed consent
排除标准
- •Prior treatment including surgery, chemotherapy or radiation therapy for the current primary breast cancer.
- •Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational device administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this
研究组 & 干预措施
Upfront Breast Surgery
Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy
干预措施: KIBUR MICRODEVICE (Device)
Neoadjuvant Therapy
Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.
干预措施: KIBUR MICRODEVICE (Device)
Neoadjuvant Therapy
Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.
干预措施: anthracycline and taxane based chemotherapy (Drug)
结局指标
主要结局
Number of Participants With Implantable Devices
时间窗: Up to 1 year
If we are able to collect data from at least 6 out of the 12 patients, we will deem this study feasible to conduct in a larger cohort of patients.
次要结局
未报告次要终点