NCT03981705已完成不适用
Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Complete Pathologic Response (pCR)
研究概览
简要总结
This is a feasibility study to gain preliminary information regarding whether breast imaging with or without a core needle biopsy after neoadjuvant chemotherapy (NAC) but before surgery can accurately predict complete pathologic response (pCR) in women with triple negative or HER2- positive breast cancer. pCR is defined as having no residual invasive breast cancer or ductal carcinoma in situ.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Biopsy proven triple negative (TN) (ER-/PR-/HER2-) or HER2 positive (ERany/PRany/HER2+) breast cancer for which neoadjuvant chemotherapy is planned
- •A biopsy clip placed at the time of diagnostic biopsy
- •18 years of age or older
- •Must be able to read and write in English due to the importance of survey (questionnaire) completion to meet the study's endpoint - this is justified as there is no individual benefit to study participation
- •Able to provide written consent prior to any research related activities
排除标准
- •Stage IV breast cancer
- •T4 breast cancer
- •Previous ipsilateral breast cancer
- •Any contraindication for undergoing a contrast-enhanced breast MRI and/or the breast biopsy between chemotherapy and surgery
结局指标
主要结局
Complete Pathologic Response (pCR)
时间窗: 6 Months Post Surgery
The primary aim of this feasibility study is to determine whether breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC) can accurately predict complete pathologic response (pCR) in women with biopsyproven triple negative or HER2+ breast cancer.
次要结局
- Complications and Side Effects of the Needle Biopsy Procedure after NAC(6 Months Post Surgery)
研究者
研究点 (1)
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