Breast NeoplasmsNCT07850154
Impact of Robotic Versus Endoscopic Surgery on Nipple Nerve Function Following Nipple-Sparing Mastectomy for Breast Cancer
A study testing Robotic-assisted nipple-sparing mastectomy and Endoscopic-assisted nipple-sparing mastectomy in people with Breast Neoplasms, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial summary
This is a multicenter, prospective, randomized parallel controlled two arm clinical trial, designed to systematically evaluate impact of robotic versus endoscopic surgery on breast nerve function in patients undergoing nipple sparing mastectomy for breast cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Robotic-assisted nipple-sparing mastectomy and Endoscopic-assisted nipple-sparing mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 1 Oct 2031
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ductal carcinoma in situ (DCIS), or invasive breast cancer with clinical stage T1-T3, N0-N1 and no distant metastasis;
- Breast size ≤ cup C, without significant breast ptosis;
- Patients with high aesthetic requirements who elect single-incision robotic or endoscopic-assisted nipple-sparing mastectomy;
- Patients eligible for prophylactic mastectomy;
- Patients understand the study protocol and sign the written informed consent form.
Who cannot join
- Tumor invasion of the nipple-areola complex, skin, or chest wall;
- Inflammatory breast cancer;
- Patients with poor general condition who are unable to tolerate surgery.
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
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, Guangdong, 510000
Haiyan Li, +8615813340604, lihaiyan@gwcmc.org
About this study
Official title: A Multicenter, Prospective, Randomized Two-arm Controlled Trial Comparing the Impact of Robotic Versus Endoscopic Surgery on Breast Nerve Function Following Nipple-sparing Mastectomy for Breast Cancer
This is a multicenter, prospective, randomized parallel controlled two arm clinical trial, designed to systematically evaluate impact of robotic versus endoscopic surgery on breast nerve function in patients undergoing nipple sparing mastectomy for breast cancer. The study will comprehensively assess the neurological functional outcomes, oncological safety, quality of life and sexual health, perioperative efficacy, surgical complications, and health economic value of the two minimally invasive approaches.
This study has been approved by the Institutional Review Board of the Affiliated Women and Children's Medical Center of Guangzhou Medical University. Written informed consent will be obtained from all eligible participants prior to enrollment. All patient data will be anonymized and kept strictly confidential. Statistical analyses will be performed using SPSS 27.0 software, with a P value < 0.05 set as the threshold for statistical significance.
- Conditions
- Breast Neoplasms
- Being tested
- Robotic-assisted nipple-sparing mastectomy, Endoscopic-assisted nipple-sparing mastectomy
- Keywords
- Breast cancer, Nipple-sparing mastectomy, Robot-assisted surgery, Endoscopic surgery, Sensation, Erection, Quality of Life, Sexual well-being
- 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-assisted nipple-sparing mastectomyProcedure or surgery
Robotic-assisted nipple-sparing mastectomy for breast cancer.
Endoscopic-assisted nipple-sparing mastectomyProcedure or surgery
Endoscopic-assisted nipple-sparing mastectomy for breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted nipple-sparing mastectomy group | Experimental | Patients undergo robotic-assisted nipple-sparing mastectomy for breast cancer. Receives: Procedure: Robotic-assisted nipple-sparing mastectomy |
| Endoscopic-assisted nipple-sparing subcutaneous mastectomy group | Experimental | Patients undergo endoscopic-assisted nipple-sparing mastectomy for breast cancer. Receives: Procedure: Endoscopic-assisted nipple-sparing mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tactile pressure sensation of the nipple-areola complex at 6 months postoperatively
Tactile pressure sensation will be measured using Semmes-Weinstein monofilaments. The examiner will apply the device to the nipple-areola complex, using filaments of incrementally increasing force (0.07 g, 0.4 g, 2.0 g, 4.0 g, 300 g), and record the lightest filament detectable by the patient.
Measured: 12 months postoperatively
Positive surgical margin rate
Measured: Intraoperative / postoperative (2 weeks after surgery)
Secondary outcomes (13)
Tactile pressure sensation of the nipple-areola complex and breast skin at multiple postoperative time points
Tactile pressure sensation will be measured using Semmes-Weinstein monofilaments. The examiner will apply the device to the nipple-areola complex and predefined quadrants of the surrounding breast skin, using filaments of incrementally increasing force (0.07 g, 0.4 g, 2.0 g, 4.0 g, 300 g), and record the lightest filament detectable by the patient.
Measured: Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively
Temperature sensation of the nipple-areola complex and breast skin
Temperature sensation will be assessed at the nipple-areola complex and predefined quadrants of the breast skin. Cold sensation is tested with an ice hammer, and warm sensation is tested using the heating mode of a massage device.
Measured: Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively
Erection function of the nipple-areola complex
Nipple erection function will be evaluated by stimulation of the nipple-areola complex using the vibration mode of a massage device.
Measured: Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively
Patient-reported outcomes
Patient-reported breast-specific sensory function, quality of life and sexual well-being will be assessed using the BREAST-Q™ Sensation Module (Pre- and Postoperative) Version 2.0 and BREAST-Q™ Breast Cancer Core Scale (Pre- and Postoperative) Version 2.0 (Sexual Well-being subscale). All subscales yield Rasch-transformed scores ranging from 0 (worst outcome) to 100 (best outcome): higher scores represent better breast sensory function, fewer breast symptoms, less negative quality-of-life impact from breast sensation alteration, and superior sexual well-being, respectively.
Measured: Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively
Disease-free survival (DFS)
Disease-free survival (DFS), defined as the time from surgery to the first occurrence of recurrence, metastasis, or death. DFS will be compared between the two study groups.
Measured: Following surgery up to 3 years
Overall survival (OS)
Overall survival (OS), defined as the time from surgery to death from any cause. OS will be compared between the two study groups.
Measured: Following surgery up to 3 years
Recurrence and Metastasis Events
The incidence of axillary recurrence, locoregional recurrence, and distant metastasis is compared between the two groups, with all events confirmed by histopathological or radiological evidence.
Measured: Following surgery up to 3 years
Postoperative Complications
The incidence of postoperative complications, including but not limited to: nipple-areola complex necrosis, infection, seroma, hematoma, is compared between the two groups.
Measured: Within 30 days post-surgery and at long-term follow-up assessments
Cost-Utility Analysis
A cost-utility analysis will be performed to compare the two groups. The incremental cost-utility ratio (ICUR) will be calculated to evaluate the cost-utility of the two surgical strategies.
Measured: Following surgery up to 3 years
Operative Time
Operative time (minutes) is compared between the two groups.
Measured: During surgery, recorded in the operative note
Axillary operation
Record the axillary surgical procedure of the two groups (None/Sentinel lymph node dissection/Axillary lymph node dissection)
Measured: During surgery, recorded in the operative note
Intraoperative Blood Loss
Intraoperative Blood Loss(mL) is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups.
Measured: During surgery, recorded in the operative note
Postoperative Recovery Parameters
Length of postoperative hospital stay (days) and duration of postoperative drainage (days) are compared between the robotic-assisted and endoscopic-assisted groups.
Measured: During index hospitalization and within 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, haiyanli, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850154
- Sponsor's protocol ID
- 285A01
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the prospective design of this study and concerns regarding patient privacy and confidentiality. The data are collected in accordance with the study protocol under the approval of the ethics committee, with written informed consent obtained from all enrolled participants, and the original consent forms do not include provisions for data sharing with external researchers. Therefore, IPD sharing is not planned. However, summarized data and analytical codes may be available from the corresponding author upon reasonable request, subject to institutional and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Two-arm Controlled Trial Comparing the Impact of Robotic Versus Endoscopic Surgery on Breast Nerve Function Following Nipple-sparing Mastectomy for Breast Cancer
- ClinicalTrials.gov ID
- NCT07850154
- Acronym / sponsor ID
- 285A01
- Conditions
- Breast Neoplasms
- Keywords
- Breast cancer, Nipple-sparing mastectomy, Robot-assisted surgery, Endoscopic surgery, Sensation, Erection, Quality of Life, Sexual well-being
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 30 Sep 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 is a multicenter, prospective, randomized parallel controlled two arm clinical trial, designed to systematically evaluate impact of robotic versus endoscopic surgery on breast nerve function in patients undergoing nipple sparing mastectomy for breast cancer. The study will comprehensively assess the neurological functional outcomes, oncological safety, quality of life and sexual health, perioperative efficacy, surgical complications, and health economic value of the two minimally invasive approaches.
This study has been approved by the Institutional Review Board of the Affiliated Women and Children's Medical Center of Guangzhou Medical University. Written informed consent will be obtained from all eligible participants prior to enrollment. All patient data will be anonymized and kept strictly confidential. Statistical analyses will be performed using SPSS 27.0 software, with a P value < 0.05 set as the threshold for statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted nipple-sparing mastectomy group | Experimental | Procedure: Robotic-assisted nipple-sparing mastectomyPatients undergo robotic-assisted nipple-sparing mastectomy for breast cancer. |
| Endoscopic-assisted nipple-sparing subcutaneous mastectomy group | Experimental | Procedure: Endoscopic-assisted nipple-sparing mastectomyPatients undergo endoscopic-assisted nipple-sparing mastectomy for breast cancer. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Ductal carcinoma in situ (DCIS), or invasive breast cancer with clinical stage T1-T3, N0-N1 and no distant metastasis;
- Breast size ≤ cup C, without significant breast ptosis;
- Patients with high aesthetic requirements who elect single-incision robotic or endoscopic-assisted nipple-sparing mastectomy;
- Patients eligible for prophylactic mastectomy;
- Patients understand the study protocol and sign the written informed consent form.
Key exclusion criteria (3 listed)
- Tumor invasion of the nipple-areola complex, skin, or chest wall;
- Inflammatory breast cancer;
- Patients with poor general condition who are unable to tolerate surgery.
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-assisted nipple-sparing mastectomyRobotic-assisted nipple-sparing mastectomy for breast cancer. | Procedure or surgery | Robotic-assisted nipple-sparing mastectomy group |
| Endoscopic-assisted nipple-sparing mastectomyEndoscopic-assisted nipple-sparing mastectomy for breast cancer. | Procedure or surgery | Endoscopic-assisted nipple-sparing subcutaneous mastectomy group |
Primary outcome
Tactile pressure sensation of the nipple-areola complex at 6 months postoperatively
Time frame: 12 months postoperatively
Tactile pressure sensation will be measured using Semmes-Weinstein monofilaments. The examiner will apply the device to the nipple-areola complex, using filaments of incrementally increasing force (0.07 g, 0.4 g, 2.0 g, 4.0 g, 300 g), and record the lightest filament detectable by the patient.
Positive surgical margin rate
Time frame: Intraoperative / postoperative (2 weeks after surgery)
13 secondary outcomes
Tactile pressure sensation of the nipple-areola complex and breast skin at multiple postoperative time points
Time frame: Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively
Temperature sensation of the nipple-areola complex and breast skin
Time frame: Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively
Erection function of the nipple-areola complex
Time frame: Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively
Patient-reported outcomes
Time frame: Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively
Disease-free survival (DFS)
Time frame: Following surgery up to 3 years
Overall survival (OS)
Time frame: Following surgery up to 3 years
Recurrence and Metastasis Events
Time frame: Following surgery up to 3 years
Postoperative Complications
Time frame: Within 30 days post-surgery and at long-term follow-up assessments
Cost-Utility Analysis
Time frame: Following surgery up to 3 years
Operative Time
Time frame: During surgery, recorded in the operative note
Axillary operation
Time frame: During surgery, recorded in the operative note
Intraoperative Blood Loss
Time frame: During surgery, recorded in the operative note
Postoperative Recovery Parameters
Time frame: During index hospitalization and within 30 days post-surgery
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 30 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the prospective design of this study and concerns regarding patient privacy and confidentiality. The data are collected in accordance with the study protocol under the approval of the ethics committee, with written informed consent obtained from all enrolled participants, and the original consent forms do not include provisions for data sharing with external researchers. Therefore, IPD sharing is not planned. However, summarized data and analytical codes may be available from the corresponding author upon reasonable request, subject to institutional and ethical approval.
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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-assisted nipple-sparing mastectomy and Endoscopic-assisted nipple-sparing mastectomy in people with Breast Neoplasms, run by Guangzhou Women and Children's Medical Center 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 5 inclusion and 3 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 30 Sep 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 (+8615813340604, lihaiyan@gwcmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tactile pressure sensation of the nipple-areola complex at 6 months postoperatively (time frame: 12 months postoperatively). The study lists 2 primary outcomes in all. 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 30 Sep 2026.