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

NCT07781163 | Not Yet Recruiting

• 1 other identifier: SPRA-BS Trial
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Outcomes (2)

• 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

Study Arms (1)

single-port

EXPERIMENTAL

Patients in this arm will have single-port robot-assisted breast surgery

Procedure: single-port robot-assisted surgery

Interventions

single-port robot-assisted surgery PROCEDURE

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.

single-port

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): December 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-06