Evaluation of the Safety and Efficacy of Single-Port Robot-Assisted Endoscopic Breast-Conserving Surgery and Nipple-sparing Matectomy With Reconstruction in Early-Stage Breast Cancer Patients

Evaluation of the Safety and Efficacy of Single-Port Robot-Assisted Endoscopic Breast-Conserving Surgery and Nipple-Sparing Mastectomy With Reconstruction in Early-Stage Breast Cancer Patients: A Single-Center, Single-Arm, Prospective Interventional Clinical Trial

This study is testing a new, less invasive way to perform breast cancer surgery using a single-port robotic system (a robot-assisted surgical tool made in China, called the Shurui SR-ENS-600). The robot works through one small hidden incision (about 3-4 cm) in the armpit or under the breast fold, instead of multiple cuts or a large open wound.

We want to find out whether this robot-assisted surgery is safe and effective for women with early-stage breast cancer who need either:

Breast-conserving surgery (lumpectomy), or

Total removal of breast tissue with immediate reconstruction using a breast implant.

You may be able to join if you:

Are a woman aged 18-70 years;

Have been diagnosed with early-stage breast cancer (by biopsy);

Are suitable for either breast-conserving surgery or mastectomy with immediate implant reconstruction;

Are in good general health (able to tolerate surgery and anesthesia);

Are willing to receive the robotic surgery and complete the follow-up visits.

If you join, you will:

Receive the robotic surgery as your main treatment;

Stay in the hospital for a short period after surgery (about 1-7 days);

Come back for follow-up visits at 1, 3, 6, 12, and 24 months after surgery;

Be asked to complete a few simple questionnaires about your recovery, satisfaction with breast appearance, and quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: single-port robot-assisted surgery

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female patients aged 18 to 80 years;
2. Histopathologically confirmed invasive breast cancer or ductal carcinoma in situ (DCIS);
3. Clinical stage I-II for breast-conserving surgery, or clinical stage I-III for subcutaneous mastectomy with immediate prosthetic reconstruction;
4. Planned to undergo breast-conserving surgery or subcutaneous mastectomy with immediate prosthetic reconstruction;
5. For breast-conserving surgery: maximum tumor diameter ≤ 3 cm, with a favorable tumor-to-breast volume ratio for breast conservation;
6. For subcutaneous mastectomy with immediate prosthetic reconstruction: willingness and appropriate indication for prosthetic reconstruction, with moderate breast volume;
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
8. American Society of Anesthesiologists (ASA) physical status classification I-III;

9. Adequate vital organ function meeting the following criteria:

   Hematology: absolute neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 90 × 10⁹/L, hemoglobin ≥ 90 g/L;

   Liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5 × ULN;

   Renal function: creatinine ≤ 1.5 × ULN;

   Coagulation function: INR ≤ 1.5, APTT ≤ 1.5 × ULN;

10. Voluntary participation with written informed consent signed.

Exclusion Criteria:

1. Prior history of breast surgery (excluding biopsy procedures);
2. Prior history of chest wall radiotherapy;
3. Pregnant or lactating women;
4. Concurrent malignancy (excluding adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
5. Severe cardiopulmonary dysfunction precluding tolerance to general anesthesia;
6. Severe hepatic or renal insufficiency;
7. Coagulation disorders or ongoing anticoagulant therapy that cannot be discontinued;
8. Active infection, particularly in the breast region;
9. Allergy or intolerance to silicone implant materials (for patients undergoing prosthetic reconstruction);
10. Severe breast ptosis or excessively large breast volume (for patients undergoing prosthetic reconstruction);
11. Presence of any contraindication to surgery, or any condition that the investigator deems unsuitable for study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single-port; Patients in this arm will have single-port robot-assisted breast surgery	Procedure: single-port robot-assisted surgery; All enrolled participants will receive single-port robot-assisted endoscopic breast cancer surgery. Patient will receive either breast-conserving surgery (BCS) or nipple-sparing mastectomy with immediate prosthetic reconstruction depending on the tumor burden.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical success rate	Defined as robotic surgery completed without conversion to conventional open surgery or conventional endoscopic/laparoscopic surgery, with R0 resection achieved.	Perioperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Total operative time	Perioperative
Estimated intraoperative blood loss	Perioperative
Robotic console time	Perioperative
Postoperative hospital stay	at hospital discharge, assessed up to 4 weeks postoperatively

Other Outcome Measures

Outcome Measure	Time Frame
Positive margin rate	Perioperative
3-year disease-free survival (DFS)	From date of surgery completion until date of first recurrence or death, ass essed up to 3 years

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: August 21, 2026
• First Posted (Actual): August 24, 2026

Study Record Updates

• Last Update Posted (Actual): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: SPRA-BS Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No