Percutaneous Cryoablation of Low-risk Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Procedure failure rate
研究概览
简要总结
Expand the current evidence base regarding percutaneous cryoablation of early-stage, low-risk breast tumors, integrated into the standard therapeutic pathway with well-defined follow-up data, as well as data on quality of life. Demonstrate, therefore, that the use of percutaneous cryoablation in the treatment of low-risk breast carcinoma is not inferior to surgery when combined with adjuvant radiotherapy and chemotherapy (when necessary). The hypothesis is that cryoablation, being simple and oncologically effective, ensures a better quality of life for the patient (reduced morbidity, no need for general anesthesia, improved cosmetic outcomes) and consequently has a lesser psychological impact, as well as a better cost-benefit ratio compared to the standard surgical approach.
详细描述
PRECICE is a prospective single arm, single centre, observational study which aims to enroll patients ≥50 years old, diagnosed with early-stage luminal A/B, unifocal Breast Cancer (BC), < 15 mm in size, without in situ component detected at imaging (by breast ultrasound, Magnetic Resonance Imaging (MRI), Mammography) and confirmed by needle biopsy, defining histotype and biology. All patients that receive treatment with cryoablation as their standard care for BC followed by RadioTherapy (RT), according to the MultiDisciplinary Tumor Board (MDTB) referral and fulfil the inclusion criteria, will be prospectively included in the study.
Follow-up protocol involved breast imaging with mammography, ultrasound, and MRI, assessment of procedure failure rate, quality of life, psychological impact, oncological outcome and economical efficacy. Adjuvant therapy will be planned after further multidisciplinary discussion
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumour, Node, Metastasis stage (TNM) = dimension up to 15 mm as measured by breast ultrasound, MRI, Mammography, Node negative, absence of distant metastasis
- •Unifocality
- •All invasive cancer, except lobular
- •Biology= luminal A and luminal B* (Estrogen Receptor (ER) positive/human epidermal growth factor receptor-2 (HER2)negative) (Documented estrogen receptor (ER)-positive tumor assessed locally and defined as ≥10% of tumor cells stained positive.
- •Documented HER2-negative tumor (in accordance to 2018 American Society of Clinical Oncology guidelines, as determined per local assessment)
- •Any grade (G)
- •Radiological detection= breast ultrasound, MRI, Mammography
- •Tumor site= not located superficially (≥1 cm from the skin plane)
- •Breast size= any, appropriate for the procedure in relation to ultrasound examination
- •Referral to breast cryoablation by a multidisciplinary tumor board
- •Planned treatment with cryoablation using IceCure (TM-trade mark) system
- •Informed consent *Luminal B and G3 BC: previous specific patients' selection and Oncotype Dx [31] on cancer tissue from needle biopsy before procedure and eventual Prediction Analysis of Microarray 50 (PAM50) test.
排除标准
- •Plurifocality
- •Invasive lobular breast cancer
- •HER2 overexpressed or Triple Negative Breast Cancer (TNBC)
- •tumor dimension >15 mm
- •Node positive
- •post NeoAdjuvant ChemoTherapy (NACT) breast cancer
- •<50 years
- •Presence of intraductal component (DCIS)
- •Absence of psychological compliance in understanding and adhering to rationale of the study
- •Inability to perform MRI
- •Breast augmentation with implants
研究组 & 干预措施
Cryoablation
Percutaneous Cryoablation of Breast Cancer
干预措施: Cryoablation (Procedure)
结局指标
主要结局
Procedure failure rate
时间窗: 8 months
Percentage of patients with residual tumor at the site of cryoablation
次要结局
- Assessment of subject's quality of life in terms of evaluation of sources of distress(60 months)
- Ipsilateral breast tumor recurrence(60 months)
- Distant metastasis(60 months)
- Assessment of subject's satisfaction(60 months)
- Cost-analysis - evaluation of cost of intervention, hospitalization and re-intervention (if applicable)(60 months)