Evaluation for the Effectiveness and Safety of Cryo-ablation in the Treatment of Early Invasive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Stage 1: Effectiveness of cryo-ablation
研究概览
简要总结
Recently, researchers in America reported a clinical research (Alliance Z1072) which proved that cryo-ablation could be considered as a non-surgical treatment of early-stage breast cancer. The long term effectiveness and safety of cryo-ablation in early invasive breast cancer is still unknown. Therefore, this prospective study are designed to evaluate the effectiveness and safety of cryo-ablation in early invasive 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •invasive ductal carcinoma proved by core needle biopsy. Other type of breast cancer should be well considered and decided by investigators. Pathological report should be complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary).
- •lump can be detected by ultrasound.
- •image results (including ultrasound, mammography and MR image) prove the lump is single-center, the maximum diameter of the lump <2cm.
- •with enough breast tissue, and enough space from lump to skin.
- •patients is not pregnant and has no plan for pregnancy in 2 years.
- •ECOG level: 0-2
- •serum creatinine≤1.1 mg/dl
- •for patients with double side (left and right side) breast cancer, both side of the tumor should meet the inclusion criteria.
- •patients are accessible for the follow up and mentally healthy.
- •≥18 years old
- •invasive ductal carcinoma proved by core needle biopsy. Other type of breast cancer should be well considered and decided by investigators. Pathological report should be complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary).
- •lump can be detected by ultrasound.
- •image results (including ultrasound, mammography and MR image) prove the lump is single-center, the maximum diameter of the lump <1.5cm.
- •with enough breast tissue, and enough space from lump to skin.
- •clinically N0 before cryo-ablation.
- •patients is not pregnant and has no plan for pregnancy in 2 years.
- •ECOG level: 0-2
- •serum creatinine≤1.1 mg/dl
- •for patients with double side (left and right side) breast cancer, both side of the tumor should meet the inclusion criteria.
- •patients are accessible for the follow up and mentally healthy.
排除标准
- •< 18 years old
- •the same side breast of the lump have been treated by surgery or other physical treatment within 3months.
- •benign tumor or tumor in situ or tumor in situ with micro-invasion proved by core needle biopsy. Pathological report is not complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary).
- •image results (including ultrasound, mammography and MR image) prove the lump is multi-center, the maximum diameter of the lump ≥2cm.
- •image results (including ultrasound, mammography) prove calcium region ≥ 5mm
- •lump can not be clearly detected by ultrasound. For example, the boundary of tumor is not clear, or the maximum diameter detected by MRI is more than 1.5 times larger than the maximum diameter detected by ultrasound.
- •before the endpoint, patients is treated by other local treatment.
- •ECOG Level >2
- •serum creatinine>1.1 mg/dl
- •patients are not accessible for the follow up and mentally unhealthy.
- •patients are pregnant or lactating, or have plan for pregnancy in 2 years.
- •other situations which make patients not suitable for the trail or cryo-ablation.
- •< 18 years old
- •the same side breast of the lump have been treated by surgery or other physical treatment within 3months.
- •benign tumor or tumor in situ or tumor in situ with micro-invasion proved by core needle biopsy. Pathological report is not complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary).
- •absolute contraindication for breast conserving surgery.
- •image results (including ultrasound, mammography and MR image) prove the lump is multi-center, the maximum diameter of the lump ≥1.5cm.
- •image results (including ultrasound, mammography) prove calcium region ≥ 5mm
- •lump can not be clearly detected by ultrasound. For example, the boundary of tumor is not clear, or the maximum diameter detected by MRI is more than 1.5 times larger than the maximum diameter detected by ultrasound.
- •NOT clinically N0 before cryo-ablation.
- •patients are treated after neoadjuvant chemotherapy or neoadjuvant endocrine therapy.
- •patients with advanced breast cancer or other type of cancers.
- •with BRCA1/2 mutation
- •before the endpoint, patients is treated by other local treatment.
- •ECOG Level >2
- •serum creatinine>1.1 mg/dl
- •can not finish the radiotherapy afterwards or with contraindication of radiotherapy
- •patients are not accessible for the follow up and mentally unhealthy.
- •patients are pregnant or lactating, or have plan for pregnancy in 2 years.
- •other situations which make patients not suitable for the trail or cryo-ablation.
结局指标
主要结局
Stage 1: Effectiveness of cryo-ablation
时间窗: 1 month
In the first stage, patients will receive traditional surgery 1month after the cryo-ablation. After the traditional surgery (mastectomy or breast conserving surgery), the pathological report will show whether there is tumor tissue left in the breast tissue. If there is no tumor left in breast, cryo-ablation is effective in eliminating the tumor. Otherwise, cryo-ablation is ineffective.
Stage 2: Effectiveness of cryo-ablation (3 months after cryo-ablation)
时间窗: 3 month
In the second stage, patients will receive muti-point core needle biopsy (which collect multi-point tissue from the region which was once the tumor region, as reported by MRI or ultrasound) 3months after the cryo-ablation. After the multi-point core needle biopsy, the pathological report will show whether there there is tumor tissue left in the breast tissue. If there is no tumor left in breast, cryo-ablation is effective in eliminating the tumor. Otherwise, cryo-ablation is ineffective.
Stage 2: LRFS(local-regional free survival)
时间窗: 5 years
In the second stage, 5-year local-regional free survival will be evaluated for patients with the treatment of cryo-ablation and traditional surgery is spared.
次要结局
- Stage 1: instant success rate(3 minutes)
- Stage 1: negative predictive value of ultrasound(14 days and 28 days)
- Stage 2: breast self evaluation(5 years)
- Stage 1: adverse events(1 month)
- Stage 2: instant success rate(3 minutes)
- Stage 2: shrinking rate(5 years)
- Stage 2: adverse events(5 years)