Single-port robotic breast-conserving surgery through the armpit

Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer.

This project will try single-port robotic breast-conserving surgery through the armpit in adults (18–65) with early invasive breast cancer who are candidates for breast conservation and compare it with traditional open breast-conserving surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Academic / other)
• Locations: 2 sites (Chongqing, Chongqing Municipality and 1 other locations)
• Trial ID: NCT06738654 on ClinicalTrials.gov

What this trial studies

Adults who meet inclusion criteria will receive either single-port robot-assisted breast-conserving surgery via an axillary incision or conventional open breast-conserving surgery, with the surgical approach chosen based on patient financial considerations and equipment availability rather than random assignment. Preoperative imaging and clinical data are collected, and intraoperative metrics such as operating time, blood loss, and intraoperative events are recorded. Postoperative outcomes include complications, pain scores, pathological margins, length of hospital stay, and complication/mortality rates tracked at 28 and 90 days. The study compares safety, feasibility, perioperative recovery, and cosmetic-related outcomes between the two approaches.

Who should consider this trial

Good fit: Adults aged 18–65 with early-stage invasive breast cancer who are suitable candidates for breast-conserving surgery, have not had prior chest surgery or radiotherapy, and have no contraindications to anesthesia are the intended participants.

Not a fit: Patients with inflammatory breast cancer, extensive or multifocal disease that makes negative margins or an acceptable cosmetic result unlikely, diffuse malignant calcifications, positive margins that cannot be cleared by re-resection, prior chest surgery or radiotherapy, or those who refuse the procedure are unlikely to benefit.

Why it matters

Potential benefit: If successful, the single-port axillary robotic approach could reduce visible chest scarring and better preserve breast shape while matching or improving recovery and complication rates versus open surgery.

How similar studies have performed: Robotic and endoscopic approaches to breast-conserving and nipple-sparing procedures have been reported in small series with promising cosmetic and recovery results, but the single-port axillary robotic technique remains relatively novel and has limited comparative published data.

Eligibility criteria

Inclusion Criteria:

1. The patient himself has very high requirements for beauty, and requires no scar on the chest;
2. No chest surgery and radiotherapy.
3. No contraindications to surgery and anesthesia.
4. Clinical I, stage of early breast cancer and the breast has an appropriate volume, can maintain a good breast shape after surgery.
5. Patients in the clinical period who meet the standard of breast conservation surgery after preoperative treatment.
6. Age: 18 and 65 years old.

Exclusion Criteria:

1. Inflammatory breast cancer.
2. The tumor is extensive and it's difficult to achieve negative margins or an ideal breast - conserving appearance.
3. Diffusely distributed malignant - characteristic calcifications.
4. The margin is positive after local extensive tumor resection, and a negative margin in pathological examination still can't be ensured after re - resection.
5. The patient refuses.

Where this trial is running

Chongqing, Chongqing Municipality and 1 other locations

• Aramy medical center. — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Army Medical Center — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: yan xu Xu, Doctor

Conditions Invasive Breast Carcinoma