Cryoablation for the Treatment of Luminal Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Cryoablation success rate
研究概览
简要总结
LUBRECA will evaluate the safety and efficacy of cryoablation with liquid nitrogen to treat cT1cN0 luminal breast cancer diagnosed in postmenopausal women
详细描述
This is a prospective transversal study that will include 140 postmenopausal women with unifocal invasive breast cancer diagnosed with core or vacuum-assisted biopsy, up to 2 cm measured in ultrasound and contrast enhanced mammography, without metastatic lymph nodes in axillary ultrasound, hormone receptor positive and human epidermal factor receptor 2 (HER) negative. Patients with invasive lobular carcinoma, extensive intraductal component, not suitable for surgery or with metastatic disease will be excluded.
Participants will receive cryoablation treatment of the tumor and, after, they will undergo radio-guided surgical resection. The presence of residual viable tumoral cells will be evaluated in the surgical specimen. Axillary evaluation during surgery and adjuvant treatment will be planned accordant to the usual clinical practice.
Cryoablation and surgery side effects and tolerance will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women diagnosed with invasive breast cancer by core needle biopsy or vacuum-assisted biopsy
- •Lesion ≤ 2 cm (on ultrasound and contrast enhanced mammography)
- •No axillary lymphadenopathy on ultrasound
- •No axillary lymph node involvement on ultrasound.
- •Luminal tumor (estrogen and/or progesterone receptor positive)
- •HER2 negative
- •Signed informed consent
排除标准
- •Infiltrating lobular carcinoma
- •Extensive in situ component
- •Multifocality or multicentricity
- •Contraindication for contrast mammography
- •Not candidate for surgery
- •Distant metastasis -
研究组 & 干预措施
Breast cancer
Early stage luminal breast cancers up to 2 cm
干预措施: Cryoablation with liquid nitrogen (Prosense® system) (Device)
结局指标
主要结局
Cryoablation success rate
时间窗: 30days after cryoablation
Absence of tumor cells in a surgical specimen
次要结局
- Proportion of patients who are free of cryoablation related complications per CTCAE v 5.0(One day and one week after cryoablation)
- Patient tolerance to cryoablation and surgery(60 days after cryoablation)
- Analyze the impact of broadening the inclusion criteria comparing to previous trials(36 months)
研究者
Lucía Graña López
Chief of the Breas Unit
Hospital Universitario Lucus Augusti