CRYO-TOUCH: Cryoablation of the Primary Breast Tumor in Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Ipsilateral Breast Tumor Recurrence at 12 Months
研究概览
简要总结
Metastatic breast cancer remains an incurable disease for most patients. While surgical treatment of the primary breast tumor is commonly performed in localized breast cancer, its role in metastatic breast cancer remains controversial due to the lack of demonstrated survival benefit and the potential interruption of systemic anticancer therapies.
Cryoablation is a minimally invasive outpatient procedure that destroys tumor tissue through controlled freezing. In localized breast cancer, cryoablation has shown promising results regarding local tumor control, safety, and patient quality of life. However, evidence regarding its use in metastatic breast cancer remains limited.The primary objective of this prospective single-center cohort study is to evaluate local tumor control 12 months after cryoablation of the primary breast tumor in patients with metastatic breast cancer.
详细描述
Metastatic breast cancer remains an incurable disease for most patients. While surgical treatment of the primary breast tumor is commonly performed in localized breast cancer, its role in metastatic breast cancer remains controversial due to the lack of demonstrated survival benefit and the potential interruption of systemic anticancer therapies.
Cryoablation is a minimally invasive outpatient procedure that destroys tumor tissue through controlled freezing. In localized breast cancer, cryoablation has shown promising results regarding local tumor control, safety, and patient quality of life. However, evidence regarding its use in metastatic breast cancer remains limited.
Preliminary retrospective data and local clinical experience suggest that cryoablation of the primary breast tumor may be feasible, safe, and associated with favorable local control in selected patients with metastatic breast cancer. Additional prospective data are needed to better characterize its clinical outcomes and its potential role as an alternative local treatment option.
The primary objective of this prospective single-center cohort study is to evaluate local tumor control 12 months after cryoablation of the primary breast tumor in patients with metastatic breast cancer.
Secondary objectives include evaluation of procedure-related safety, postoperative complications, pain, quality of life, treatment interruption, and implementation outcomes such as acceptability, appropriateness, feasibility, fidelity, and sustainability among both patients and healthcare professionals.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged ≥18 years.
- •Histologically confirmed metastatic breast carcinoma, regardless of histological subtype, hormone receptor status, HER2 status, or tumor grade.
- •Receiving systemic anticancer treatment for metastatic breast cancer, including chemotherapy, immunotherapy, endocrine therapy, targeted therapy, or combination regimens.
- •Clinical response or stable disease according to RECIST v1.1 on the most recent imaging assessment performed within 3 months before enrollment, except for the primary breast lesion, which may be progressing.
- •Eligible for cryoablation of the primary breast tumor:
- •ECOG Performance Status ≤
- •Effective contraception for women of childbearing potential.
- •Able and willing to provide written informed consent.
排除标准
- •Contraindication to cryoablation according to the investigator and/or interventional radiologist.
- •Contraindication to gadolinium-enhanced breast MRI according to institutional practice and radiologist assessment.
- •Pregnant or breastfeeding women.
- •Participation in another interventional clinical study with an ongoing exclusion period or that could interfere with the present study according to investigator judgment.
- •Psychiatric disorder or any medical condition that, in the opinion of the investigator, could compromise study participation or compliance with study procedures.
- •Adults under legal protection or unable to provide informed consent.
- •Persons deprived of liberty by judicial or administrative decision.
- •Absence of health insurance coverage.
结局指标
主要结局
Ipsilateral Breast Tumor Recurrence at 12 Months
时间窗: 12 months after cryablation
Presence of ipsilateral breast tumor recurrence (IBTR) 12 months after cryoablation of the primary breast tumor. IBTR is defined as invasive local recurrence identified on breast MRI and, when indicated, confirmed by biopsy.
次要结局
未报告次要终点