Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer: a Prospective Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- positive margin rate
研究概览
简要总结
The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.
详细描述
The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 patients, age≥18 year
- •A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
- •Patients pathologically diagnosed with untreated breast cancer by core-needle biopsy, with histologically confirmed non-palpable in situ cancer, including pleomorphic lobular carcinoma in situ or invasive non-palpable breast cancer that required localization
- •Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery.
- •Exclusion criteria:
- •Inflammatory breast cancer or Paget's disease
- •Breast deformities and other conditions that impact breast conservation success rate
- •Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded
- •Pregnancy or lactation
- •Patients with hookwire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment
- •Patients with stage IV diseases or unresectable lesions in either breast
- •Patients combined with other diseases that may affect survival
- •Patients with multicentric breast cancer lesions or lesions > 5 cm in diameter on imaging examinations
- •Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy
排除标准
- 未提供
结局指标
主要结局
positive margin rate
时间窗: up to 3 months
It is defined as the proportion of patients in whom in situ or invasive carcinoma is found in the cavity margins after the first resection, including intraoperative frozen-section analysis and postoperative formalin-fixed paraffin-embedded analysis, subject to postoperative analysis.
次要结局
- IDFS(2 years, 3 years, and 5 years)
- The proportion of breast-conserving surgery(up to 3 months after first operation)
- Re-operation rate(up to 3 months after first operation)
研究者
Chang Gong
Clinical Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University