Does Breast Tumor Heterogeneity Necessitate Additional HER2 Testing on the Surgical Specimens?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Benefit of additional Her2 testing
研究概览
简要总结
Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are not routinely repeated on surgical specimens (SS). However, preliminary data suggests that testing these biomarkers, on SS when compared to CNB samples can lead to different results. Our hypothesis is that The aim of this study is to identify a group of women with invasive breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas of HER2 amplification are not missed. Another aim is to determine whether further HER2 testing on the SS in select patients would lead to changes in breast cancer treatment options.
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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women > age 18 with capacity to consent
- •Invasive breast cancer identified on CNB at AAMC within 45 days of study consent
- •IHC biomarkers performed on original CNB (including HER2)
- •Tumors with greater than 2cm of invasive disease (measured radiographically prior to resection or microscopically after resection), or
- •Multifocal or multicentric tumors
排除标准
- •Women with HER2 positive tumors detected on CNB specimens
- •Women receiving neoadjuvant chemotherapy
- •Women whose CNB or surgical resection was performed at a hospital other than AAMC. If the CNB prior to resection was repeated at AAMC and new tumor biomarkers were performed, then the patient is eligible for enrollment
- •Women whose IHC marker results were inconclusive on CNB or not performed -
结局指标
主要结局
Benefit of additional Her2 testing
时间窗: 2 years
To identify a subset of women with invasive breast cancer who may benefit from additional Her2 testing (by immunochemistry and FISH) on their surgical specimen to ensure that areas of Her2 amplification are not missed due to sampling error of the core needle biopsy.
次要结局
未报告次要终点