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.
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;
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);
Single group
single-port robot-assisted surgery
Procedure/SurgeryAll 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.
Surgical success rate
Defined as robotic surgery completed without conversion to conventional open surgery or conventional endoscopic/laparoscopic surgery, with R0 resection achieved.
Total operative time
Estimated intraoperative blood loss
Robotic console time
Postoperative hospital stay
Positive margin rate
3-year disease-free survival (DFS)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
