Clinical Efficacy and Safety Assessment of Breast-Conserving Surgery for Central Breast Cancer: A Prospective Randomized Controlled Trial
This study enrolled 158 patients with primary central early-stage breast cancer and randomly assigned them to two groups. The control group underwent total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), while the experimental group received breast-conserving surgery combined with radiotherapy (nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement was present; conversion to total mastectomy required for intraoperative or postoperative positive margins). The primary endpoint was local recurrence rate, with secondary endpoints including disease-free survival (DFS), overall survival (OS), patient-reported outcomes (PRO), and surgery-related complications.
• Female patients aged 18-70 years with primary breast cancer;
• Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:
‣ TNM stage T1-2;
⁃ Nodal stage N0-1;
• Ductal carcinoma in situ (DCIS) with maximum tumor diameter \<3 cm;
• Paget's disease;
• Neoadjuvant chemotherapy permitted for eligible patients;
• Unicentric lesion confirmed by breast ultrasound, mammography, and MRI;
• Nipple-areolar complex resection required for preoperative imaging or pathologically confirmed nipple involvement;
• Enrolled patients randomized 1:1 to breast-conserving surgery or total mastectomy group;
• Participants voluntarily signed informed consent forms and completed ethics review procedures.