Can a Pathological Complete Response in the Breast be Diagnosed by Vacuum-assisted, Ultrasound Guided Minimal Invasive Biopsy After Neoadjuvant Chemotherapy in Breast Cancer Patients? A Proof of Concept From a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- false negative rate to diagnose a pathological complete response by vacuum-assisted biopsy for the whole cohort and predefined subgroups
研究概览
简要总结
The study aims to evaluate the ability of representative vacuum-assisted minimal invasive biopsy (VAB) to diagnose pathological complete response (pCR=ypT0) in breast cancer patients after neoadjuvant chemotherapy (NACT).
详细描述
Neoadjuvant chemotherapy (NACT) is an increasingly used approach for patients with locally advanced and primarily inoperable breast cancer or for patients with potentially chemosensitive tumors. In clinical routine surgical treatment follows the pre-operative chemotherapy. However, recent studies have demonstrated that shrinking tumors need less surgical treatment indicating that patients with pCR could potentially be spared of surgery in the future.
Up to now, prediction of pCR after NACT, i.e. diagnosing a pCR without surgery, is based on tumor biology at diagnosis, the applied NACT regimen and breast imaging results; all with mediocre accuracy. This prospective, monocenter diagnostic trial aims to explore if minimal invasive biopsies (MIB) might overcome this diagnostic challenge.
From September 1st, 2014 to February 15th, 2015 the investigators performed ultrasound guided vacuum-assisted minimal invasive biopsy (VAB) on 50 breast cancer patients after NACT and directly prior to surgery. To analyse VAB pathologically results were categorized as follows: residual vital tumor cells (invasive, in situ, both, lymphangiosis carcinomatosous) present, (significant parts of) the tumor bed present, neither vital tumor cells nor (significant parts of) the tumor bed (indicating a non representative VAB). The results were compared to those of the pathological examination of surgical specimen.
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
- •The investigators included patients
- •after neoadjuvant chemotherapy (NACT) according to the NACT protocol
- •with at least one detectable mass / marker after NACT in ultrasound
- •with cT1c-cT4a-c tumors
- •after informed consent
- •with unilateral or bilateral primary breast cancer, confirmed histologically prior to chemotherapy
- •with known grading, ER/PgR/HER-2neu- and Ki-67 status
- •with breast ultrasound, mammography (and breast MRI where necessary) before and after NACT
- •clinical / imaging partial or complete response to NACT
排除标准
- •The investigators excluded patients from the study with
- •NACT <12 weeks because of termination due to progressive disease, massive adverse events or patient wish
- •non-detectable mass in ultrasound / dislocation of marker (> 10mm distance to the initial lesion)
- •cT4d stage (inflammatory breast cancer)
- •M1 stages
- •stable disease according to a multimodal assessment of ultrasound, mammography and breast MRI (if available) according to RECIST
研究组 & 干预措施
vacuum-assisted biopy
All patients enrolled in this study received a vacuum-assisted biopsy before surgery.
干预措施: vacuum-assisted biopsy (Procedure)
结局指标
主要结局
false negative rate to diagnose a pathological complete response by vacuum-assisted biopsy for the whole cohort and predefined subgroups
时间窗: 1 week
As an explorative study, the statistical analysis was performed using descriptive methods only. For a baseline comparison between groups, the investigators compared the group of patients with pCR to the group of patients without pCR. As primary outcomes the investigators calculated negative predictive values (NPV) and false negative rates (FNR) for the whole study cohort as well as for certain subgroups (especially addressing the question of evaluating representativeness of VAB). The investigators calculated two-sided-95% confidence intervals for all results.
次要结局
- negative predictive values to diagnose a pathological complete response by vacuum-assisted biopsy for the whole cohort and predefined subgroups(1 week)
研究者
Jörg Heil
Prof. Dr. med Jörg Heil
Heidelberg University