A Prospective Study To Evaluate The Accuracy Of Percutaneous Breast MRI Biopsy In Diagnosing A Pathologic Complete Response Following Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 14
- 主要终点
- estimate the negative predictive value (NPV) of a percutaneous MRI biopsy
研究概览
简要总结
The purpose of this study is to test the ability of a breast MRI biopsy to accurately diagnose a complete tumor response to the neoadjuvant chemotherapy (NAC) that the patient just finished. Numerous studies have shown that MRI has the highest accuracy for diagnosing a complete tumor response. The investigator wants to see if in a certain group of women who's breast cancer is no longer visible on the post-treatment MRI that the biopsy specimens from a MRI guided biopsy will accurately diagnose a complete tumor response to treatment which may in the future make breast surgery unnecessary in some women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 18 years or older
- •Confirmed histologic diagnosis of operable HER2 overexpressing (ER<10%, PR<10%, and HER2 2+ or FISH amplified) OR triple negative (ER<10%, PR<10%, and HER2 0/1+ or 2+/FISH not amplified) OR ER positive invasive ductal or invasive lobular breast cancer including MSKCC pathology confirmation
- •Operable breast cancer treated with NAC undergoing either breast conservation or total Mastectomy who have had a post-NAC clinical bilateral breast MRI demonstrating a complete imaging response, which is defined as no residual tumor enhancement.
- •No indication of distant metastases (M0)
- •Tumor site amenable to MRI guided biopsy as determined by the radiologist
- •Definitive surgery being performed at MSKCC within within 0-60 days of completing NAC
- •ECOG performance status score of 0 to ≤ 2 and or KPS performance status score of 80% to 100%
- •Women of childbearing potential (WOCBP) must not be pregnant.
- •Women must not be breastfeeding
- •Willing and able to provide informed consent and adhere to the study visit schedule and plan as specified in this protocol
排除标准
- •Medical history and concurrent disease:
- •Prior history of treated breast cancer
- •Any underlying medical or psychiatric conditions, which in the opinion of the investigator, will make performing the study intervention hazardous or obscure the interpretation of the results
- •Prohibited Treatments and/or Therapies:
- •Prior history of breast cancer surgery and/or radiotherapy.
结局指标
主要结局
estimate the negative predictive value (NPV) of a percutaneous MRI biopsy
时间窗: 2 years
In this context NPV is defined as the number of true negatives (biopsy negative, i.e., no disease found on the percutaneous biopsy and pCR) divided by the number of all biopsy negatives. While NPV is of primary interest we will also estimate positive predictive value, sensitivity, and specificity of the biopsy.
次要结局
未报告次要终点