Comparison Between Histological VABB and Histological Post-surgery in Patient With Complete Pathological Response After Neoadjuvant Systemic Treatment: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Evaluation of the accuracy of histological examination of the VABB performed pre-surgery
研究概览
简要总结
Pilot study on patients with invasive ductal breast cancer triple negative or receptor tyrosine-protein kinase erbB-2 (HER2) overexpressed, any axillary lymphnodes status (any cN), candidates to neoadjuvant chemotherapy.
The principal endpoint of the study will be the accuracy of the result of the histological examination of the Vacuum- Assisted Breast Biopsy (VABB) performed pre-surgery in comparison to the result of the histological examination of the definitive surgical intervention in patients with radiological complete response at Magnetic resonance imaging (MRI) done after the end of neoadjuvant chemotherapy.
详细描述
The study articulates in five phases:
Phase one: acquisition of the informed consent followed by positioning a clip into the cancer bed (by radiologist) if not already present; Phase two: after radiological confirmation of pathological Complete Response (pCR) done performing breast ultrasound, MRI and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography (18-FDG-PET) after neoadjuvant chemotherapy the patient becomes candidate to VABB pre surgery.
Phase three: the patient has VABB within 15 day from the term of neoadjuvant chemotherapy Phase four: definitive surgical intervention within 30 days from the end of the neoadjuvant chemotherapy Phase five: verification of correspondence between histology of VABB and definitive histology.
The study hypothesis is that VABB could be used in the patients with pCR to the imaging post-neoadjuvant chemotherapy to confirm sensibility and specificity of 18 FDG TC PET and breast MRI to show the absence of breast cancer.
The use of VABB with negative histology result could bring to a therapeutic gold standard without over surgical treatment
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 aa;
- •histological diagnosis done at European Institute of Oncology (if not, to does revision of pathological material);
- •invasive ductal breast cancer triple negative or HER2 overexpressed, any cN;
- •neoadjuvant standard systemic treatment after surgery +/- trastuzumab;
- •propose of conservative or demolitive surgery;
- •cancer bed identified pre neoadjuvant chemotherapy by clip
排除标准
- •multicentric or bilateral breast cancer
- •mammography microcalcifications
- •in situ breast carcinoma
- •positive anamnesis for previous breast cancer
- •positive anamnesis for medical or psychological conditions that prevent membership study
结局指标
主要结局
Evaluation of the accuracy of histological examination of the VABB performed pre-surgery
时间窗: 45 days
Identification of percentage of cases with correspondence between histology of VABB presurgery and histology of definitive surgery in patients with complete radiological response after neoadjuvant chemotherapy
次要结局
未报告次要终点