Breast CancerNCT07321145
A Retrospective Analysis of Robot-Assisted Versus Endoscopic Breast-Conserving Surgery for Breast Cancer
A study testing Robotic breast-conserving surgery and Endoscopic breast-conserving surgery in people with Breast Cancer and Breast Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Robotic surgical systems provide notable advantages including enhanced dexterity, a magnified three-dimensional high-definition view, and high-resolution imaging, thereby improving operative stability and precision. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Breast Surgery
- What is being tested?
- Robotic breast-conserving surgery and Endoscopic breast-conserving surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2025to 31 May 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
- Pathologically confirmed breast cancer prior to surgery
- Sufficient glandular volume with a tumor-to-breast volume ratio ≤20%
- A unifocal lesion confined to the glandular tissue
- Clear desire for breast conservation and willingness to undergo R-BCS or E-BCS
- No evidence of distant metastasis, no involvement of the skin or chest wall
- Eligibility for standard postoperative radiotherapy
Who cannot join
- The presence of diffuse suspicious lesions or microcalcifications for which wide local resection was unlikely to achieve adequate negative margins or satisfactory aesthetic outcomes
- Bilateral breast cancer or inflammatory breast cancer
- After neoadjuvant therapy, requirement for additional concurrent surgical procedures
- Inability to tolerate general anesthesia or undergo surgery
- Contraindications to radiotherapy or a history of prior chest wall irradiation, pregnancy- or lactation-associated breast cancer
- Refuse to undergo R-BCS or E-BCS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Haiyan Li, +86 15813340604, lihy27@mail.sysu.edu.cn
About this study
Robotic surgical systems provide notable advantages including enhanced dexterity, a magnified three-dimensional high-definition view, and high-resolution imaging, thereby improving operative stability and precision. These features make robotic systems particularly suitable for procedures performed within confined operative spaces. As the breast is a solid organ without a natural cavity, robotic systems demonstrate strong adaptability for breast surgery. Robot-assisted breast-conserving surgery (RABCS) is one of the currently utilized robotic techniques in clinical breast cancer surgery. However, as robotic breast surgery remains in its early stage of development, evidence regarding the clinical outcomes of RABCS remains limited in the literature. Therefore, this study compares the surgical outcomes of endoscopic breast-conserving surgery and robot-assisted breast-conserving surgery in breast cancer patients, aiming to assess and elucidate the clinical value of RABCS.
- Conditions
- Breast Cancer, Breast Surgery
- Being tested
- Robotic breast-conserving surgery, Endoscopic breast-conserving 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.
Robotic breast-conserving surgeryProcedure or surgery
To perform breast-conserving surgery using a robotic system, thereby validating the safety and feasibility of robotic breast-conserving surgery.
Endoscopic breast-conserving surgeryProcedure or surgery
To perform breast-conserving surgery using a endoscopic system.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic breast-conserving surgery | Active comparator | Not described Receives: Procedure: Endoscopic breast-conserving surgery |
| Robotic breast-conserving surgery | Experimental | Not described Receives: Procedure: Robotic breast-conserving surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication rate
Measured: 1 month postoperatively
Secondary outcomes (3)
Operation time
Measured: Intraoperative
Aesthetic outcomes
We utilized the novel assessment tool developed by Lai et al. tailored to minimally invasive breast surgery, with specific attention to scar length, appearance, and position.
References:
Lai HW, Mok CW, Chang YT, Chen DR, Kuo SJ, Chen ST. Endoscopic assisted breast conserving surgery for breast cancer: Clinical outcome, learning curve, and patient reported aesthetic results from preliminary 100 procedures. Eur J Surg Oncol. 2020;46(8):1446-1455. doi:10.1016/j.ejso.2020.02.020
Measured: 3 month postoperatively
Blood loss
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start27 Jun 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiyan Li, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321145
- Sponsor's protocol ID
- 2025ZSLYEC-374
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang Z, Fu X, Li Z, Teng Y, Pan F, Li H. Robotic versus endoscopic breast-conserving surgery: a comparative analysis of clinical outcomes and aesthetic outcomes in breast cancer. J Robot Surg. 2026 May 13;20(1):492. doi: 10.1007/s11701-026-03466-7.
PubMed 42126517
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Robot-Assisted Versus Endoscopic Breast-Conserving Surgery for Breast Cancer
- ClinicalTrials.gov ID
- NCT07321145
- Acronym / sponsor ID
- 2025ZSLYEC-374
- Conditions
- Breast Cancer, Breast Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 6 Jan 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.
Robotic surgical systems provide notable advantages including enhanced dexterity, a magnified three-dimensional high-definition view, and high-resolution imaging, thereby improving operative stability and precision. These features make robotic systems particularly suitable for procedures performed within confined operative spaces. As the breast is a solid organ without a natural cavity, robotic systems demonstrate strong adaptability for breast surgery. Robot-assisted breast-conserving surgery (RABCS) is one of the currently utilized robotic techniques in clinical breast cancer surgery. However, as robotic breast surgery remains in its early stage of development, evidence regarding the clinical outcomes of RABCS remains limited in the literature. Therefore, this study compares the surgical outcomes of endoscopic breast-conserving surgery and robot-assisted breast-conserving surgery in breast cancer patients, aiming to assess and elucidate the clinical value of RABCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic breast-conserving surgery | Active comparator | Procedure: Endoscopic breast-conserving surgery |
| Robotic breast-conserving surgery | Experimental | Procedure: Robotic breast-conserving surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients aged 18 to 80 years
- Pathologically confirmed breast cancer prior to surgery
- Sufficient glandular volume with a tumor-to-breast volume ratio ≤20%
- A unifocal lesion confined to the glandular tissue
- Clear desire for breast conservation and willingness to undergo R-BCS or E-BCS
Key exclusion criteria (6 listed)
- The presence of diffuse suspicious lesions or microcalcifications for which wide local resection was unlikely to achieve adequate negative margins or satisfactory aesthetic outcomes
- Bilateral breast cancer or inflammatory breast cancer
- After neoadjuvant therapy, requirement for additional concurrent surgical procedures
- Inability to tolerate general anesthesia or undergo surgery
- Contraindications to radiotherapy or a history of prior chest wall irradiation, pregnancy- or lactation-associated breast cancer
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 |
|---|---|---|
| Robotic breast-conserving surgeryTo perform breast-conserving surgery using a robotic system, thereby validating the safety and feasibility of robotic breast-conserving surgery. | Procedure or surgery | Robotic breast-conserving surgery |
| Endoscopic breast-conserving surgeryTo perform breast-conserving surgery using a endoscopic system. | Procedure or surgery | Endoscopic breast-conserving surgery |
Primary outcome
Postoperative complication rate
Time frame: 1 month postoperatively
3 secondary outcomes
Operation time
Time frame: Intraoperative
Aesthetic outcomes
Time frame: 3 month postoperatively
Blood loss
Time frame: Perioperative
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 6 Jan 2026.
- Derived from this study: PubMed 42126517Huang Z, Fu X, Li Z, Teng Y, Pan F, Li H. Robotic versus endoscopic breast-conserving surgery: a comparative analysis of clinical outcomes and aesthetic outcomes in breast cancer. J Robot Surg. 2026 May 13;20(1):492. doi: 10.1007/s11701-026-03466-7.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic breast-conserving surgery and Endoscopic breast-conserving surgery in people with Breast Cancer and Breast Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Haiyan Li (+86 15813340604, lihy27@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complication rate (time frame: 1 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07321145, which also lists 1 linked publication.
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 6 Jan 2026.