One tiny incision: could robotic surgery transform breast cancer treatment?
NCT ID NCT07781163
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial is investigating whether a single-port robotic system can safely and effectively perform breast cancer surgery through one small hidden incision, instead of larger cuts. The study includes women aged 18-80 with early-stage breast cancer who are candidates for either breast-conserving surgery or nipple-sparing mastectomy with immediate implant reconstruction. Participants will undergo the robotic procedure and be followed for two years to assess surgical success, recovery, and satisfaction with breast appearance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- single-port robot-assisted endoscopic surgery (using the Shurui SR-ENS-600 system) for breast-conserving surgery or nipple-sparing mastectomy with immediate implant reconstruction
- What this could lead to
- If successful, this approach could offer women with early-stage breast cancer a less invasive surgical option with smaller hidden scars, potentially improving recovery and cosmetic satisfaction.
- What could go wrong
- This is a small, early-stage study (30 participants) at one center. The robotic technique may not be suitable for all tumors, and there are risks of complications or the need to convert to open surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
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