Clinical Trial

Clinical Efficacy and Safety Assessment of Breast-Conserving Surgery for Central Breast Cancer: A Prospective Randomized Controlled Trial

Recruiting
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Summary
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.
Trial Details
NCT Number NCT06938360
Lead Sponsor Xijing Hospital
Collaborators: Shaanxi Provincial People's Hospital, Tang-Du Hospital
Conditions Breast Cancer
Enrollment 158 participants
Start Date 2025-02-20
Primary Completion 2028-02-20 (estimated)
Study Completion 2030-02-20 (estimated)
Updated on ClinicalTrials.gov 2025-04-22