Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial.

The integration of robotic platforms in breast oncology has witnessed substantial expansion, fueled by their inherent advantages in minimally invasive access and enhanced intraoperative maneuverability. Most of the robotic-assisted breast surgery has been performed using multi-arm robots. However, the implementation of single-port robotic (SPr) systems in mammary interventions continues to undergo rigorous clinical evaluation, particularly regarding long-term oncological safety and cost-effectiveness metrics. Notably, multi-arm robotic systems demonstrate constrained operability in the restricted mammary workspace, whereas the transaxillary, single-port approach demonstrates enhanced spatial adaptability, achieving more optimal instrument articulation in confined surgical fields while concurrently optimizing aesthetic outcomes through precise subcutaneous tissue dissection. The study (ClinicalTrials.gov ID: NCT06738654) constituted a prospective, single-arm, non-randomized trial for primary exploration of feasibility and safety regarding a single-port robotic system in breast-conserving surgery (BCS) in six patients with early-stage breast cancer undergoing transaxillary, SPr-assisted, partial mastectomy with sentinel lymph node biopsy (SLNB). A total of 6 patients from Daping Hospital (Army Medical Center) between December 2024 and February 2025 were included in this study, with the first successful implementation performed on December 24, 2024. Intraoperative frozen-section histopathology confirmed negative resection margins in all patients, meeting the criteria for surgical success. The mean operative time was 232 min, with an average postoperative drainage volume of 250 mL. The axillary drainage tubes remained for an average of 10 days; the mean hospital stay was 10 days. Quality of life assessment through FACT-B demonstrated satisfaction scores. The six cases demonstrate the procedural safety and oncological feasibility of transaxillary SPr-assisted BCS within minimally invasive breast oncology. Mechanistically, the axillary portal approach achieves scar containment through only one incision in the inframammary fold, while preserving the native breast architecture. This technique significantly improves postoperative quality of life metrics through precise subcutaneous fascia preservation, reducing psycho-emotional distress associated with visible scarring. The technical paradigm aligns with oncoplastic principles by reconciling radical tumor excision with contemporary aesthetic demands in breast cancer candidates.