Breast CancerNCT06561646
To Evaluate the Effectiveness and Safety of the Single-port Robotic-assisted Breast Surgery in Breast Cancer
A study testing single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy and single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy and single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2024to 31 Dec 2028
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Male breast cancer or inflammatory breast cancer;
- Metastatic breast cancer (stage IV); Tumor invasion of the skin, pectoralis major muscle, or NAC;
- The clinical data is basically incomplete;
- Previously received chemotherapy in an external hospital or has undergone tumor resection in an external hospital;
- Bilateral breast cancer surgery;
- Other surgical methods;
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- Preoperative distant metastasis or supraclavicular lymph node dissection;
- Complicated with other malignant tumors or had malignant tumors other than breast cancer in recent 5 years;
- The serious disease of non malignant tumors combined will affect the patient's compliance or put the patient in a dangerous state;
- Dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms.
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
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210009
Qiang Ding, Professor, +8613951731373, dingqiang@njmu.edu.cn
About this study
Official title: A Prospective, Single-center, Single-arm Clinical Study to Evaluate the Effectiveness and Safety of the Single-port Robotic-assisted Breast Surgery in Breast Cancer
The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the abdominal endoscopic surgery system and evaluate the effectiveness and safety of the single-port robotic-assisted breast surgery in breast cancer.
- Conditions
- Breast Cancer
- Being tested
- single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy, single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection
- Keywords
- single-port robotic-assisted breast 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 robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsyProcedure or surgery
the single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy in the management of breast cancer
single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissectionProcedure or surgery
the single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection in the management of breast cancer
| Study group | Role | What they receive |
|---|---|---|
| single-port robotic-assisted breast surgery | Experimental | the single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy in the management of breast cancer; single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection Receives: Procedure: single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy; Procedure: single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence free survival rate
Local recurrence refers to the recurrence of the chest wall or breast on the same side as the surgical site.
Measured: Ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start21 Aug 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (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 The First Affiliated Hospital with Nanjing Medical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561646
- Sponsor's protocol ID
- BC-Robot-20240810
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Indicate if there is a plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Single-arm Clinical Study to Evaluate the Effectiveness and Safety of the Single-port Robotic-assisted Breast Surgery in Breast Cancer
- ClinicalTrials.gov ID
- NCT06561646
- Acronym / sponsor ID
- BC-Robot-20240810
- Conditions
- Breast Cancer
- Keywords
- single-port robotic-assisted breast surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 21 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Aug 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.
The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the abdominal endoscopic surgery system and evaluate the effectiveness and safety of the single-port robotic-assisted breast surgery in breast cancer.
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 robotic-assisted breast surgery | Experimental | Procedure: single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy, Procedure: single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissectionthe single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy in the management of breast cancer; single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Male breast cancer or inflammatory breast cancer;
- Metastatic breast cancer (stage IV); Tumor invasion of the skin, pectoralis major muscle, or NAC;
- The clinical data is basically incomplete;
- Previously received chemotherapy in an external hospital or has undergone tumor resection in an external hospital;
- Bilateral breast cancer 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 |
|---|---|---|
| single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsythe single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy in the management of breast cancer | Procedure or surgery | single-port robotic-assisted breast surgery |
| single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissectionthe single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection in the management of breast cancer | Procedure or surgery | single-port robotic-assisted breast surgery |
Primary outcome
Local recurrence free survival rate
Time frame: Ten years
Local recurrence refers to the recurrence of the chest wall or breast on the same side as the surgical site.
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 20 Aug 2024.
- Individual participant dataSharing planned: Yes. Indicate if there is a plan to make individual participant data (IPD) available to other researchers.
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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 single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy and single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 0 inclusion and 10 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 20 Aug 2024. 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 Qiang Ding, Professor (+8613951731373, dingqiang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence free survival rate (time frame: Ten years). 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 20 Aug 2024.