Breast CancerNCT07781163
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
A study testing single-port robot-assisted surgery in people with Breast Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- single-port robot-assisted surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 14Show fewer
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
About this study
Official title: 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:
Read more
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
- Being tested
- single-port robot-assisted surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-port robot-assisted surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| single-port | Experimental | Patients in this arm will have single-port robot-assisted breast surgery Receives: Procedure: single-port robot-assisted surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success rate
Defined as robotic surgery completed without conversion to conventional open surgery or conventional endoscopic/laparoscopic surgery, with R0 resection achieved.
Measured: Perioperative
Secondary outcomes (4)
Total operative time
Measured: Perioperative
Estimated intraoperative blood loss
Measured: Perioperative
Robotic console time
Measured: Perioperative
Postoperative hospital stay
Measured: at hospital discharge, assessed up to 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start30 Dec 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781163
- Sponsor's protocol ID
- SPRA-BS Trial
- Status last verified
- Jun 2026
- First submitted
- 18 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07781163
- Acronym / sponsor ID
- SPRA-BS Trial
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-port | Experimental | Procedure: single-port robot-assisted surgeryPatients in this arm will have single-port robot-assisted breast surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single-port robot-assisted 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. | Procedure or surgery | single-port |
Primary outcome
Surgical success rate
Time frame: Perioperative
Defined as robotic surgery completed without conversion to conventional open surgery or conventional endoscopic/laparoscopic surgery, with R0 resection achieved.
4 secondary outcomes
Total operative time
Time frame: Perioperative
Estimated intraoperative blood loss
Time frame: Perioperative
Robotic console time
Time frame: Perioperative
Postoperative hospital stay
Time frame: at hospital discharge, assessed up to 4 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing single-port robot-assisted surgery in people with Breast Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success rate (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.