Refusal of Breast Surgery in Patients With Breast Cancer With a Clinical Complete Response (cCR) After Neoadjuvant Systemic Therapy and a Confirmed Pathological Complete Response (pCR) Using Vacuum-assisted Biopsy (VAB) and Sentinel Lymph Node Biopsy (SLNB)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- False negative rate of vacuum-assisted biopsy (FNR)
研究概览
简要总结
The main goal of the study is to abandon breast surgery in patients with breast cancer with a clinical complete response (cCR) after neoadjuvant systemic therapy and confirmed pCR using Vacuum-assisted biopsy (VAB) and sentinel lymph node biopsy (SLNB).
Evidence of the high diagnostic accuracy (sensitivity and specificity) of vacuum aspiration biopsy in determining pCR in patients with clinical complete response after neoadjuvant systemic therapy will allow abandoning breast surgery in favor of radiation therapy alone, improving the quality of life of these patients.
详细描述
Vacuum-assisted removal and biopsy of the tumor bed after neoadjuvant systemic therapy (NST) in patients with clinical complete clinical response with a biopsy of sientinel lymph nodes is in the future a modern alternative to the standard, often crippling and traumatic surgical procedures and does not require additional financial costs for the reconstruction of the breast.
There are only two trial visits that are specific to the trial. All other visits will be routine visits.
The first trial visit before NST will take place in order to provide the patient with detailed information on the study, its' aims, the VAB procedure, and its risks. The patient will be asked to sign a form of informed consent.
In the second visit after the NST, VAB planning will be carried out. This visit may vary depending on the patient, the tumor, and the characteristics of the study site. We will provide each test participant with the opportunity to choose the appropriate conditions for the procedure.
The VAB procedure with a sentinel lymph node biopsy will be performed in the operating room Research objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Triple negative breast cancer / HER2-positive breast cancer (ER / PR +/-)
- •age> 18 years.
- •morphologically confirmed diagnosis of breast cancer, IIA-IIIA stage
- •ECOG score 0-
- •life expectancy of more than 3 months.
- •the consent of patients to use reliable methods of contraception throughout the study
- •adequate liver and bone marrow function
- •the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).
排除标准
- •Inconsistency with inclusion criteria.
- •Conducting earlier any systemic therapy for breast cancer.
- •stage 4 cancer
- •carrier mutations of the BRCA1 / 2 gene
- •severe uncontrolled concomitant chronic diseases or acute diseases
- •the presence of a second malignant tumor
- •pregnancy or lactation
- •acute conditions and complications, which, according to the doctor, interfere with treatment
结局指标
主要结局
False negative rate of vacuum-assisted biopsy (FNR)
时间窗: During the surgery
Achieving a false-negative rate (FNR) of less than 15% in the surgical and vacuum-assisted biopsy specimens
次要结局
未报告次要终点