Breast CancerNCT06706726
To Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection Combined With Immediate Breast Reconstruction in Breast Cancer
A study testing sentinel lymph node biopsy and Single-port robotic-assisted axillary lymph node dissection in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
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?
- sentinel lymph node biopsy and Single-port robotic-assisted axillary lymph node dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 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
- Female patients, aged 18-75 years old; The pregnancy test (-) and reliable contraceptive methods are required for premenopausal and perimenopausal patients;
- Patients with the diagnosed breast cancer confirmed by core needle biopsy and unilateral operation was performed; Breast cancer patients with tumor node metastasis stage 0-III according to the 8th edition of the American Joint Commission on Cancer; Preoperative clinical examination or imaging evaluation shows that the distance between the tumor and the Nipple Areolar Complex (NAC) is more than 1cm. The tumor has a diameter of 2-3 cm and can be located in any quadrant or reduced to 3 cm through preoperative neoadjuvant chemotherapy. The distance between the lesion and the skin should be at least 8-10 mm;
- There is no clinical or imaging evidence to prove that the tumor has invaded the skin, chest wall, or nipple areola complex;
- There are indications for breast preservation, but the patient has a strong desire for reconstruction and is unwilling to undergo breast preservation surgery;
- Preventive mastectomy (BRCA1/2 malignant mutation with obvious family history of breast cancer and other high-risk groups);
- Preoperative clinical manifestations and imaging data showed no distant metastasis;
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- No history of breast cancer or other serious underlying diseases in the past;
- Karnofsky performance status score ≥ 70;
- Eastern Cooperative Oncology Group score ≤ 2 ;
- The surgical procedure includes a single-port robot (Endoscopic Instrument Control System SP1000) for subcutaneous gland resection, sentinel lymph node biopsy, axillary lymph node dissection and immediate breast reconstruction;
- Participants are able to understand the research process, voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up;
- No swallowing difficulties; No shoulder joint movement disorders;
- Complete clinical data.
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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Single-center, Double-arm Clinical Study to Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection Combined With Immediate Breast Reconstruction 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, double-arm clinical study was conducted to use the single-port robot and evaluate the effectiveness and safety of the subcutaneous gland resection combined with immediate breast reconstruction in breast cancer.
- Conditions
- Breast Cancer
- Being tested
- sentinel lymph node biopsy, Single-port robotic-assisted axillary lymph node dissection
- Keywords
- Single-port Robotic-assisted subcutaneous gland resection combined with immediate breast reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sentinel lymph node biopsyProcedure or surgery
sentinel lymph node biopsy during the management of breast cancer
Single-port robotic-assisted axillary lymph node dissectionProcedure or surgery
Single-port robotic-assisted（Endoscopic Instrument Control System SP1000) axillary lymph node dissection during the management of breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Group A: Single-port robotic-assisted breast surgery including sentinel lymph node biopsy | Experimental | Single-port robotic-assisted（Endoscopic Instrument Control System SP1000）subcutaneous gland resection and sentinel lymph node biopsy combined with immediate breast reconstruction in the management of breast cancer Receives: Procedure: sentinel lymph node biopsy |
| Group B: Single-port robotic-assisted breast surgery including axillary lymph node dissection | Experimental | Single-port robotic-assisted（Endoscopic Instrument Control System SP1000）subcutaneous gland resection and axillary lymph node dissection combined with immediate breast reconstruction in the management of breast cancer Receives: Procedure: Single-port robotic-assisted 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 posted27 Nov 2024
- Study start1 Dec 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706726
- Sponsor's protocol ID
- BC-Robot-20241101
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Double-arm Clinical Study to Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection Combined With Immediate Breast Reconstruction in Breast Cancer
- ClinicalTrials.gov ID
- NCT06706726
- Acronym / sponsor ID
- BC-Robot-20241101
- Conditions
- Breast Cancer
- Keywords
- Single-port Robotic-assisted subcutaneous gland resection combined with immediate breast reconstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Nov 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, double-arm clinical study was conducted to use the single-port robot and evaluate the effectiveness and safety of the subcutaneous gland resection combined with immediate breast reconstruction in breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Single-port robotic-assisted breast surgery including sentinel lymph node biopsy | Experimental | Procedure: sentinel lymph node biopsySingle-port robotic-assisted（Endoscopic Instrument Control System SP1000）subcutaneous gland resection and sentinel lymph node biopsy combined with immediate breast reconstruction in the management of breast cancer |
| Group B: Single-port robotic-assisted breast surgery including axillary lymph node dissection | Experimental | Procedure: Single-port robotic-assisted axillary lymph node dissectionSingle-port robotic-assisted（Endoscopic Instrument Control System SP1000）subcutaneous gland resection and axillary lymph node dissection combined with immediate breast reconstruction in the management of breast cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female patients, aged 18-75 years old; The pregnancy test (-) and reliable contraceptive methods are required for premenopausal and perimenopausal patients;
- Patients with the diagnosed breast cancer confirmed by core needle biopsy and unilateral operation was performed; Breast cancer patients with tumor node metastasis stage 0-III according to the 8th edition of the American Joint Commission on Cancer; Preoperative clinical examination or imaging evaluation shows that the distance between the tumor and the Nipple Areolar Complex (NAC) is more than 1cm. The tumor has a diameter of 2-3 cm and can be located in any quadrant or reduced to 3 cm through preoperative neoadjuvant chemotherapy. The distance between the lesion and the skin should be at least 8-10 mm;
- There is no clinical or imaging evidence to prove that the tumor has invaded the skin, chest wall, or nipple areola complex;
- There are indications for breast preservation, but the patient has a strong desire for reconstruction and is unwilling to undergo breast preservation surgery;
- Preventive mastectomy (BRCA1/2 malignant mutation with obvious family history of breast cancer and other high-risk groups);
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 |
|---|---|---|
| sentinel lymph node biopsysentinel lymph node biopsy during the management of breast cancer | Procedure or surgery | Group A: Single-port robotic-assisted breast surgery including sentinel lymph node biopsy |
| Single-port robotic-assisted axillary lymph node dissectionSingle-port robotic-assisted（Endoscopic Instrument Control System SP1000) axillary lymph node dissection during the management of breast cancer | Procedure or surgery | Group B: Single-port robotic-assisted breast surgery including axillary lymph node dissection |
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 29 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing sentinel lymph node biopsy and Single-port robotic-assisted axillary lymph node dissection in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
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 13 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 29 Nov 2024. 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?
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 29 Nov 2024.