NCT02200705已完成不适用
Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 34
- 主要终点
- Local Inbreast Breast Tumor Recurrence (IBTR) Rate
研究概览
简要总结
To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Competent to sign informed consent
- •Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
- •Unifocal primary disease NOTE: Patients with multifocal and/or multicentric in breast cancer, or evidence of EIC are NOT eligible. Patients with contralateral disease will remain eligible.
- •Tumor size ≤1.5 cm in greatest diameter in the axis parallel to the treatment probe AND ≤1.5 cm in the axis anti-parallel to the treatment probe AND ≤1.5 cm in Anterior/ Posterior dimension. Tumor size ≤1.5 cm in greatest diameter as measured by breast ultrasound, mammogram and/or MRI. The largest dimension measured will be used to determine eligibility.
- •Nottingham grade 1-
- •Specifically, nuclear and mitotic scores must be less than or equal to
- •Estrogen receptor-positive, progesterone receptor-positive, HER2 negative
- •Breast size adequate for safe cryoablation
- •Lesion must be sonographically visible at the time of treatment.
- •History of previously treated ipsilateral or contralateral breast carcinoma is not an
排除标准
- •if the investigator is certain newly diagnosed carcinoma is new unifocal primary tumor.
- •Exclusion Criteria:
- •Presence of lobular carcinoma
- •Presence of luminal B pathology
- •Nottingham score of 3 (specially nuclear and mitotic score>2)
- •Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC)
- •Presence of multifocal and/or multicentric in breast cancer
- •Presence of multifocal calcifications
- •Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer
- •Presence of prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
- •Patient that is not suitable to cryoablation procedure according to the physician opinion
- •ER AND PR negative, or Her2 positive noted on pre-cryo biopsy
研究组 & 干预措施
single arm, open label
Other
Early stage Breast cancers up to 1.5cm
干预措施: Ice-Sense3TM/ ProSenseTM (Device)
结局指标
主要结局
Local Inbreast Breast Tumor Recurrence (IBTR) Rate
时间窗: up to 5 years
6 months post cryoabltion, then annually for 5 years
次要结局
- Complete Ablation of Primary Tumor(up to 5 years from procedure date.)
- Improvement or Maintenance of Subject's Quality of Life(at 6 months compare to the base line)
- Breast Cosmetics Satisfaction(up to 5 years from procedure data.)
- Regional Recurrence Rate(up to 5 years)
- Distant Metastases Rate(up to 5 years)
- Overall Survival(up to 5 years)
- Breast Cancer Survival.(up to 5 years)
- Adverse Events(up to 2 years for AEs and up to 5 years for SAEs)
- Disease-free Survival (DFS)(up to 5 years)
- Complete Primary Tumor Ablation Rate(up to 5 years from procedure date.)
- Improvement or Maintenance of Subject's Quality of Life(Baseline and 6 months)
- Breast Cosmetics Satisfaction(Up to 5 years following procedure)
- Regional Recurrence Rate(up to 5 years following procedure)
- Distant Metastases Survival Rate(up to 5 years following procedure)
研究者
研究点 (34)
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