Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 24
- 主要终点
- Tumor ablation occurence
研究概览
简要总结
This study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer. The hypothesis is that cryoablation will complete ablation and destroy the tumor in a selected population of women who may otherwise be adequately treated with surgery.
详细描述
PURPOSE:
To determine the rate of successful tumor ablation in patients treated with cryoablation and endocrine therapy in a subset of patients with early stage breast cancer.
OUTLINE:
- Core Biopsy (Pre-Registration)
- Magnetic Resonance Imaging (Pre-Registration)
- Tumor Cryoablation
- Core Biopsy (Post-Cryoablation)
- Magnetic Resonance Imaging (Post-Cryoablation)
- Postoperative Follow-up
- Evaluation of outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy
- •Maximum tumor size ≤1.5 cm in its greatest diameter
- •Ultrasound visible lesion(s)
- •Clinically node negative, hormone receptor positive (+). HER2 negative (-), with <25% intraductal component in the aggregate.
- •Unilateral or bilateral disease meeting study criteria
- •Physical and emotional ability to undergo baseline and follow-up breast MRIs and serial breast cosmesis analysis
- •Patient agrees to receive a 5 year minimum course of endocrine therapy following cryoablation for control of systemic disease
排除标准
- •Prior treatment (e.g., open surgical biopsy, lumpectomy) of index cancer
- •Ductal carcinoma in-situ with microinvasions (T1mic)
- •Multifocal or multicentric invasive breast carcinoma
- •Prior or planned neoadjuvant systemic therapy for breast cancer
- •Tumor with ≥25% IDC components
研究组 & 干预措施
Low Risk - Age 70+
Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
干预措施: Visica 2 Treatment System (Device)
Moderate Risk - Age 50-69
Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
干预措施: Visica 2 Treatment System (Device)
结局指标
主要结局
Tumor ablation occurence
时间窗: Within 6 months
Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma. Will be determined at 6-month post-cryoablation biopsy. Residual disease will require surgery.
次要结局
- Satisfactory breast cosmesis results(5 Years)
- Local tumor recurrence(Within 5 years)
- Adverse event assessment(5 years)