Invasive Breast Carcinoma单孔机器人-SPRNCT06738654
Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer.
A study testing robot-surgery and traditional open surgry in people with Invasive Breast Carcinoma, run by Xu Yan at 2 sites in China.
Trial summary
Evaluate the safety,feasibility and quality of life(QoL)of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Invasive Breast Carcinoma
- What is being tested?
- robot-surgery and traditional open surgry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesChina
- Study dates
- 31 Dec 2024to 31 Dec 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient himself has very high requirements for beauty, and requires no scar on the chest;
- No chest surgery and radiotherapy.
- No contraindications to surgery and anesthesia.
- Clinical I, stage of early breast cancer and the breast has an appropriate volume, can maintain a good breast shape after surgery.
- Patients in the clinical period who meet the standard of breast conservation surgery after preoperative treatment.
- Age: ≥18 years old.
Who cannot join
- Inflammatory breast cancer.
- The tumor is extensive and it's difficult to achieve negative margins or an ideal breast - conserving appearance.
- Diffusely distributed malignant - characteristic calcifications.
- The margin is positive after local extensive tumor resection, and a negative margin in pathological examination still can't be ensured after re - resection.
- The patient refuses.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Aramy medical center.
Chongqing, Chongqing Municipality, 400042
Yan Xu, 86 23 68729250, xy931@163.com
- Recruiting
Army Medical Center
Chongqing, Chongqing Municipality
Yan Xu, +86 15923100038, xy931@163.com
About this study
Evaluate the safety,feasibility and quality of life(QoL)of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in breast cancer breast-conserving surgery, in order to select a more effective and safe surgical method. Subjects who meet the inclusion criteria will enter the research process, with surgery including SPr-breast-conserving surgery or open-breast-conserving surgery, and the choice of the two surgical methods is based on the patient's financial situation and the availability of equipment;
Read the detailed description
Evaluate the safety and feasibility of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in breast cancer breast-conserving surgery, in order to select a more effective and safe surgical method. Subjects who meet the inclusion criteria will enter the research process, with surgery including SPr-breast-conserving surgery or open-breast-conserving surgery, and the choice of the two surgical methods is based on the patient's financial situation and the availability of equipment; - Preoperative hospitalization period: Collect patient disease information (including mammography, breast ultrasound, breast enhanced MRI, etc.) - On the day of surgery: Record operating time, intraoperative blood loss, intraoperative complications, intraoperative adverse events, etc.; - Postoperative hospitalization period: Record postoperative complications (postoperative bleeding, necrosis of the flap or nipple-areola complex, subcutaneous emphysema, infection, capsule spasm, postoperative shoulder pain and discomfort, etc.), postoperative pain scores, postoperative pathological biopsy; - Postoperative hospital stay: Calculated from the day of surgery to the day of discharge; - 28 days postoperatively: Understand the complication rate and mortality rate within 28 days postoperatively; - 90 days postoperatively: Understand the complication rate and mortality rate within 90 days postoperatively; - 3-year disease-free survival period (calculated from the time of surgery to the last follow-up or recurrence and metastasis date, recurrence is defined as recurrence in the surgical area and distant metastasis); - 3-year overall survival rate (calculated from the time of surgery to the last follow-up or death).
In addition, postoperative quality of life and psychosocial satisfaction were assessed in all patients. Questionnaire surveys for quality of life were conducted at 1 week, 1 month, 3 months, 6 months, 12 months, 24 months and 36 months after surgery.
- Conditions
- Invasive Breast Carcinoma
- Being tested
- robot-surgery, traditional open surgry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-surgeryProcedure or surgery
Breast-conserving surgery for breast cancer using single-port robotic surgery.
traditional open surgryProcedure or surgery
Breast-conserving surgery for breast cancer using traditional open surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Breast-conserving surgery for breast cancer using traditional open surgery. Receives: Procedure: traditional open surgry |
| Experimental Group | Experimental | Breast-conserving surgery for breast cancer using single-port robotic surgery. Receives: Procedure: robot-surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The successful rate of breast-conserving surgery
Whether intraoperative frozen section biopsy of the surgical margins detects cancer cells; if it is negative after two or fewer attempts, then the breast-conserving surgery is considered successful.
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (1)
Post-surgery Quality of Life
Measured: Post-suegery in 1 week, 1month,3months,6months,12moths,24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start31 Dec 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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 Invasive Breast CarcinomaStudies of the same condition, open and under way.
- 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
- Model description
- Experimental Group: Breast-conserving surgery for breast cancer using single-port robotic surgery. Control Group: Breast-conserving surgery for breast cancer using traditional open surgery.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu Yan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738654
- Sponsor's protocol ID
- AMCIIT241104
- Acronym
- 单孔机器人-SPR
- Status last verified
- Aug 2026
- First submitted
- 29 Nov 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it contains privacy about patients
Publications
Yu F, Zhang G, Guo L, Luo F, Chen Y, Xu Y. Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial. J Vis Exp. 2025 Aug 19;(222). doi: 10.3791/68459.
PubMed 40920680
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer.
- ClinicalTrials.gov ID
- NCT06738654
- Acronym / sponsor ID
- 单孔机器人-SPR / AMCIIT241104
- Conditions
- Invasive Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Xu YanUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Dec 2024 (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.
Evaluate the safety,feasibility and quality of life(QoL)of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in breast cancer breast-conserving surgery, in order to select a more effective and safe surgical method. Subjects who meet the inclusion criteria will enter the research process, with surgery including SPr-breast-conserving surgery or open-breast-conserving surgery, and the choice of the two surgical methods is based on the patient's financial situation and the availability of equipment;
Detailed description
Evaluate the safety and feasibility of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in breast cancer breast-conserving surgery, in order to select a more effective and safe surgical method. Subjects who meet the inclusion criteria will enter the research process, with surgery including SPr-breast-conserving surgery or open-breast-conserving surgery, and the choice of the two surgical methods is based on the patient's financial situation and the availability of equipment; - Preoperative hospitalization period: Collect patient disease information (including mammography, breast ultrasound, breast enhanced MRI, etc.) - On the day of surgery: Record operating time, intraoperative blood loss, intraoperative complications, intraoperative adverse events, etc.; - Postoperative hospitalization period: Record postoperative complications (postoperative bleeding, necrosis of the flap or nipple-areola complex, subcutaneous emphysema, infection, capsule spasm, postoperative shoulder pain and discomfort, etc.), postoperative pain scores, postoperative pathological biopsy; - Postoperative hospital stay: Calculated from the day of surgery to the day of discharge; - 28 days postoperatively: Understand the complication rate and mortality rate within 28 days postoperatively; - 90 days postoperatively: Understand the complication rate and mortality rate within 90 days postoperatively; - 3-year disease-free survival period (calculated from the time of surgery to the last follow-up or recurrence and metastasis date, recurrence is defined as recurrence in the surgical area and distant metastasis); - 3-year overall survival rate (calculated from the time of surgery to the last follow-up or death).
In addition, postoperative quality of life and psychosocial satisfaction were assessed in all patients. Questionnaire surveys for quality of life were conducted at 1 week, 1 month, 3 months, 6 months, 12 months, 24 months and 36 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental Group: Breast-conserving surgery for breast cancer using single-port robotic surgery. Control Group: Breast-conserving surgery for breast cancer using traditional open surgery.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: traditional open surgryBreast-conserving surgery for breast cancer using traditional open surgery. |
| Experimental Group | Experimental | Procedure: robot-surgeryBreast-conserving surgery for breast cancer using single-port robotic surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient himself has very high requirements for beauty, and requires no scar on the chest;
- No chest surgery and radiotherapy.
- No contraindications to surgery and anesthesia.
- Clinical I, stage of early breast cancer and the breast has an appropriate volume, can maintain a good breast shape after surgery.
- Patients in the clinical period who meet the standard of breast conservation surgery after preoperative treatment.
Key exclusion criteria (5 listed)
- Inflammatory breast cancer.
- The tumor is extensive and it's difficult to achieve negative margins or an ideal breast - conserving appearance.
- Diffusely distributed malignant - characteristic calcifications.
- The margin is positive after local extensive tumor resection, and a negative margin in pathological examination still can't be ensured after re - resection.
- The patient refuses.
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 |
|---|---|---|
| robot-surgeryBreast-conserving surgery for breast cancer using single-port robotic surgery. | Procedure or surgery | Experimental Group |
| traditional open surgryBreast-conserving surgery for breast cancer using traditional open surgery. | Procedure or surgery | Control Group |
Primary outcome
The successful rate of breast-conserving surgery
Time frame: From enrollment to the end of treatment at 2 weeks
Whether intraoperative frozen section biopsy of the surgical margins detects cancer cells; if it is negative after two or fewer attempts, then the breast-conserving surgery is considered successful.
1 secondary outcome
Post-surgery Quality of Life
Time frame: Post-suegery in 1 week, 1month,3months,6months,12moths,24months
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 21 Aug 2026.
- Derived from this study: PubMed 40920680Yu F, Zhang G, Guo L, Luo F, Chen Y, Xu Y. Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial. J Vis Exp. 2025 Aug 19;(222). doi: 10.3791/68459.
- Individual participant dataSharing planned: No. it contains privacy about patients
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robot-surgery and traditional open surgry in people with Invasive Breast Carcinoma, run by Xu Yan at 2 sites 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 6 inclusion and 5 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 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 yan xu Xu, Doctor (023-68729250, xy931@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The successful rate of breast-conserving surgery (time frame: From enrollment to the end of treatment at 2 weeks). 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 NCT06738654, 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 21 Aug 2026.