Prospective Clinical Trial to Assess a Mini-invasive Pre-surgical Procedure to Detect Residual Breast or Axillary Disease in Patients With cT1-T2-T3 cN0/N1 Breast Cancer in Complete Clinical/Radiological Remission After Primary Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Evaluation of the accuracy of histological examination of the breast VAB performed pre-surgery
研究概览
简要总结
Breast surgery may be overtreatment when there is a complete response to systemic neoadjuvant treatment as determined clinically and by imaging. However the reliability of imaging techniques (ultrasound, mammography and magnetic resonance) in identifying complete response varies in published studies and surgery remains the preferred method of detecting residual disease.
The aims of this study are:
- To assess the reliability of minimally invasive preoperative image-guided vacuum-assisted biopsy (VAB) in identifying residual breast in cT1-cT2-cT3, cN0-cN1 breast cancer patients, either with complete clinical/radiological response, or with residual breast disease <1 cm, after systemic neoadjuvant treatment.
- To assess the reliability of minimally invasive preoperative image-guided needle biopsy in identifying residual axillary disease in cT1-cT2-cT3, cN0-cN1 breast cancer patients, either with complete clinical/radiological response, or with residual breast disease <1 cm, after systemic neoadjuvant treatment.
After neoadjuvant treatment, and evaluation with ultrasound, mammography and magnetic resonance, VAB will be performed on the breast, and needle biopsy will be performed on the axillary lymph node of pre-treatment cN1 cases, previously marked with a magnetic clip.
The biopsy findings will be compared with the surgical findings, consisting in quadrantectomy or mastectomy plus sentinel node biopsy (or separate removal of tagged lymph nodes if they do not coincide with the sentinel node(s)) to assess the ability of biopsy to identify residual disease.
详细描述
Systemic neoadjuvant treatment was introduced in the 1990s (1,2) mainly for advanced (cT2, cT3) breast cancer to reduce the extent of disease and hence allow conservative surgery instead of mastectomy.
Studies (3-6) demonstrated that pathologic complete response (pCR) in the breast and/or axilla after neoadjuvant treatment predicted better overall survival (OS), better distant relapse-free survival (DRS), and lower mortality.
More recently, targeted neoadjuvant therapies achieve pCR in over 60% of patients (7,8) and in up to 70% of patients with HER2-positive or triple negative subtypes that are generally associated with poorer outcomes (9).
Ultrasound, mammography and magnetic resonance imaging are still imprecise in identifying surgically confirmed residual disease after neoadjuvant chemotherapy (10,11) and the sensitivity and specificity of these imaging techniques vary markedly, (12) so surgery remains the most reliable method of detecting any residual disease.
The aims of this study are
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Radiologically confirmed unifocal cT1-cT2-cT3 cN0-cN1 breast cancer patients indicated for primary chemotherapy
- •Histologically confirmed HER2-positive, triple negative or luminal B HER2-positive invasive breast cancer
- •Clinical/radiological complete response or residual breast disease <1 cm after primary chemotherapy
- •Absence of locoregional relapse or distant metastasis
- •Signed informed consent to participate.
排除标准
- •Disease surgically inoperable or surgery not performed
- •Multifocal disease or presence of microcalcifications at imaging.
结局指标
主要结局
Evaluation of the accuracy of histological examination of the breast VAB performed pre-surgery
时间窗: 40 days
Identification of percentage of cases with correspondence between pre-operative VAB findings in breast with histological findings after quadrantectomy or mastectomy in patients with complete radiological response after neoadjuvant chemotherapy.
次要结局
- Evaluation of the accuracy of histological examination of the lymph node biopsy performed pre-surgery(40 days)