A Prospective, Single-center, Double-arm Clinical Study to Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer (NJMU-Reconstruction Cohort)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Local recurrence free survival rate (LRFS)
研究概览
简要总结
The new technology of endoscopic-assisted system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of endoscopic-assisted mastectomy and immediate breast reconstruction in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, double-arm clinical study was conducted to use the endoscopic-assisted system and evaluate the effectiveness and safety of the mastectomy combined with immediate breast reconstruction in breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, aged 18-75 years old; The pregnancy test (-) and reliable contraceptive methods are required for premenopausal and perimenopausal patients;
- •Patients with the diagnosed breast cancer confirmed by core needle biopsy and unilateral operation was performed; Breast cancer patients with tumor node metastasis stage 0-III according to the 8th edition of the American Joint Commission on Cancer; Preoperative clinical examination or imaging evaluation shows that the distance between the tumor and the Nipple Areolar Complex (NAC) is more than 1cm. The tumor has a diameter of 2-3 cm and can be located in any quadrant or reduced to 3 cm through preoperative neoadjuvant chemotherapy. The distance between the lesion and the skin should be at least 8-10 mm;
- •There is no clinical or imaging evidence to prove that the tumor has invaded the skin, chest wall, or nipple areola complex;
- •There are indications for breast preservation, but the patient has a strong desire for reconstruction and is unwilling to undergo breast preservation surgery;
- •Preventive mastectomy (BRCA1/2 malignant mutation with obvious family history of breast cancer and other high-risk groups);
- •Preoperative clinical manifestations and imaging data showed no distant metastasis;
- •No history of breast cancer or other serious underlying diseases in the past;
- •Karnofsky performance status score ≥ 70;
- •Eastern Cooperative Oncology Group score ≤ 2 ;
- •The surgical procedure includes endoscopic-assisted/conventional mastectomy, sentinel lymph node biopsy/axillary lymph node dissection and immediate breast reconstruction;
- •Participants are able to understand the research process, voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up;
- •No swallowing difficulties; No shoulder joint movement disorders;
- •Complete clinical data.
排除标准
- •Male breast cancer or inflammatory breast cancer;
- •Metastatic breast cancer (stage IV); Tumor invasion of the skin, pectoralis major muscle, or NAC;
- •The clinical data is basically incomplete;
- •Previously received chemotherapy in an external hospital or has undergone tumor resection in an external hospital;
- •Bilateral breast cancer surgery;
- •Other surgical methods;
- •Preoperative distant metastasis or supraclavicular lymph node dissection;
- •Complicated with other malignant tumors or had malignant tumors other than breast cancer in recent 5 years;
- •The serious disease of non malignant tumors combined will affect the patient's compliance or put the patient in a dangerous state;
- •Dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms.
研究组 & 干预措施
endoscopic-assisted mastectomy and immediate breast reconstruction
endoscopic-assisted mastectomy and immediate breast reconstruction
干预措施: endoscopic-assisted mastectomy and immediate breast reconstruction (Procedure)
mastectomy and immediate breast reconstruction
mastectomy and immediate breast reconstruction
干预措施: mastectomy and immediate breast reconstruction (Procedure)
结局指标
主要结局
Local recurrence free survival rate (LRFS)
时间窗: 3 years
Local recurrence refers to the recurrence of the chest wall or breast on the same side as the surgical site.
Regional recurrence free survival rate (RRFS)
时间窗: 3 years
Regional recurrence refers to the recurrence in the drainage area of ipsilateral internal mammary lymph nodes, axillary lymph nodes, or supraclavicular and infraclavicular lymph nodes.
次要结局
- Disease free survival (DFS)(3 years)
- Distant metastasis free survival rate (DMFS)(3 years)
- Main complication rate(3 years)