Breast CancerNCT07532096
Extended Sentinel Lymph Node Biopsy With Methylene Blue Single Tracer Post-Neoadjuvant Therapy for Node-Positive Breast Cancer
A study testing ESLNB in people with Breast Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety and feasibility of methylene blue single tracer-based extensive sentinel lymph node biopsy (ESLNB) and provide evidence for simplifying surgical procedures on the basis of ensuring axillary safety, as well as clarify the incidence of postoperative upper limb… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ESLNB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2026to 15 May 2029
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female treatment-naive breast cancer patients aged 18 to 70 years old.
- Histopathologically confirmed invasive breast cancer, either early-stage (T1-2N0-1M0, Stage Ⅰ-Ⅱ) or locally advanced (T3N0-1M0/T1-3N1M0, Stage ⅢA) as defined by the latest ASCO/CAP guidelines; initial clinical axillary stage cN0-1 with pathologically confirmed axillary lymph node positivity via needle biopsy.
- Voluntarily accept a complete course of standard neoadjuvant therapy for 6 or 8 cycles, and achieve clinical axillary node negativity (cN0) in axillary lymph node re-evaluation by ultrasound after completion of neoadjuvant therapy.
- Willing to undergo neoadjuvant therapy plus methylene blue single tracer-guided extensive sentinel lymph node biopsy combined with axillary lymph node dissection.
- Voluntarily participate in the study and sign the informed consent form.
Who cannot join
- Patients over 70 years old.
- Newly diagnosed metastatic breast cancer (Stage Ⅳ).
- Gestational breast cancer patients.
- Patients with abnormal function of vital organs (heart, lung, liver, kidney) or poorly controlled diabetes, who are unable to tolerate surgery.
- Other conditions that the investigator deems unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Single-Arm, Open-Label Study of Extended Sentinel Lymph Node Biopsy Using Methylene Blue as a Single Tracer After Neoadjuvant Therapy in Patients With Axillary Node-Positive Breast Cancer
The goal of this clinical trial is to evaluate the safety and feasibility of methylene blue single tracer-based extensive sentinel lymph node biopsy (ESLNB) and provide evidence for simplifying surgical procedures on the basis of ensuring axillary safety, as well as clarify the incidence of postoperative upper limb lymphedema in female patients with axillary node-positive breast cancer who achieve clinical axillary node negativity after neoadjuvant therapy. The main questions it aims to answer are:
- What is the false negative rate of methylene blue single tracer-based extensive sentinel lymph node biopsy in the above-mentioned breast cancer patients?
- What are the false negative rate and detection rate of methylene blue single tracer-based conventional sentinel lymph node biopsy
- What is the incidence of upper limb lymphedema within 2 years after surgery in these patients?
Read more
Participants will:
- Undergo strict screening to confirm eligibility for the trial and sign an informed consent form
- Receive a complete standard neoadjuvant therapy for 6 or 8 cycles as required
- Undergo personalized breast surgery combined with methylene blue single tracer-based ESLNB plus axillary lymph node dissection
- Accept pathological evaluation of the number of lymph nodes and metastatic lymph nodes in each resected part after surgery
- Receive adjuvant therapies such as targeted therapy, endocrine therapy or local radiotherapy in accordance with clinical guidelines
- Complete regular follow-up for 2 years after surgery (once every 6 months), including physical sign checks, surgical site evaluations, and upper limb circumference measurements to assess lymphedema
Read the detailed description
Participants will:
- Receive a full course of standard neoadjuvant therapy for 6 or 8 cycles as clinically indicated
- Undergo preoperative screening assessments to confirm clinical axillary node negativity after neoadjuvant therapy
- Have 0.5ml of methylene blue injected into the areola before surgery and then receive personalized breast surgery combined with extensive sentinel lymph node biopsy plus axillary lymph node dissection
- Undergo pathological testing to count the total number of resected lymph nodes and metastatic lymph nodes in different axillary regions
- Receive adjuvant treatments like targeted therapy, endocrine therapy or local radiotherapy following clinical practice guidelines
- Attend clinic follow-up visits every 6 months for 2 years after surgery, including physical exams, surgical site checks and upper limb circumference measurements
- Allow their clinical, surgical, pathological and follow-up data to be collected and entered into a dedicated research database Report any physical discomfort or adverse events that occur during the study period to the research medical team in a timely manner
- Conditions
- Breast Cancer
- Being tested
- ESLNB
- Keywords
- Breast cancer, Extensive sentinel lymph node biopsy, Methylene blue
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESLNBProcedure or surgery
First, personalized breast surgery is performed in accordance with the patient's breast tumor condition (e.g., breast-conserving surgery, modified radical mastectomy).
Next, blue-stained lymphatic vessels are dissected and identified to locate and resect the primary sentinel lymph nodes (SLNs).
Subsequently, the lymphoid tissue in the extensive sentinel lymph node region (2-3cm around the resected SLNs) is completely excised (defined as ESLNB in this study).
Finally, systematic dissection and clearance of the remaining axillary lymph node regions are conducted to complete ALND.
Post-surgical wound management: The surgical wound is rinsed and soaked successively with sterile distilled water and normal saline for hemostasis; a drainage tube is placed, and the skin is sutured layer by layer in accordance with standard surgical protocols.
| Study group | Role | What they receive |
|---|---|---|
| ESLNB group | Experimental | Not described Receives: Procedure: ESLNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The false negative rate of extended sentinel lymph node biopsy.
A false negative is defined as follows: after the extended sentinel lymph node biopsy indicates a negative result, metastasis is still found in the subsequently examined axillary lymph nodes.
Measured: Two weeks after the operation
Secondary outcomes (3)
The false negative rate of sentinel lymph node biopsy
The false negative rate of sentinel lymph node biopsy using methylene blue single tracer, that is, axillary lymph nodes are positive but the sentinel lymph nodes still have lymph node metastasis
Measured: Two weeks after the operation
The detection rate of extended sentinel lymph node dissection
Number of lymph nodes detected through preoperative sentinel lymph node dissection
Measured: Two weeks after the operation
The incidence rate of upper limb lymphedema
The patients develop lymphedema in the arm on the surgical side after the breast cancer surgery.
Measured: Half a year after the operation, one year after the operation, two years after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start3 May 2026
- Primary completion1 May 2028 (estimated)
- Study completion15 May 2029 (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.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532096
- Sponsor's protocol ID
- KY20262066-F-1
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Open-Label Study of Extended Sentinel Lymph Node Biopsy Using Methylene Blue as a Single Tracer After Neoadjuvant Therapy in Patients With Axillary Node-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07532096
- Acronym / sponsor ID
- KY20262066-F-1
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Extensive sentinel lymph node biopsy, Methylene blue
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 3 May 2026 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 15 May 2029 (estimated)
- First posted
- 15 Apr 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.
The goal of this clinical trial is to evaluate the safety and feasibility of methylene blue single tracer-based extensive sentinel lymph node biopsy (ESLNB) and provide evidence for simplifying surgical procedures on the basis of ensuring axillary safety, as well as clarify the incidence of postoperative upper limb lymphedema in female patients with axillary node-positive breast cancer who achieve clinical axillary node negativity after neoadjuvant therapy. The main questions it aims to answer are:
- What is the false negative rate of methylene blue single tracer-based extensive sentinel lymph node biopsy in the above-mentioned breast cancer patients?
- What are the false negative rate and detection rate of methylene blue single tracer-based conventional sentinel lymph node biopsy
- What is the incidence of upper limb lymphedema within 2 years after surgery in these patients?
Participants will:
- Undergo strict screening to confirm eligibility for the trial and sign an informed consent form
- Receive a complete standard neoadjuvant therapy for 6 or 8 cycles as required
- Undergo personalized breast surgery combined with methylene blue single tracer-based ESLNB plus axillary lymph node dissection
- Accept pathological evaluation of the number of lymph nodes and metastatic lymph nodes in each resected part after surgery
- Receive adjuvant therapies such as targeted therapy, endocrine therapy or local radiotherapy in accordance with clinical guidelines
- Complete regular follow-up for 2 years after surgery (once every 6 months), including physical sign checks, surgical site evaluations, and upper limb circumference measurements to assess lymphedema
Detailed description
Participants will:
- Receive a full course of standard neoadjuvant therapy for 6 or 8 cycles as clinically indicated
- Undergo preoperative screening assessments to confirm clinical axillary node negativity after neoadjuvant therapy
- Have 0.5ml of methylene blue injected into the areola before surgery and then receive personalized breast surgery combined with extensive sentinel lymph node biopsy plus axillary lymph node dissection
- Undergo pathological testing to count the total number of resected lymph nodes and metastatic lymph nodes in different axillary regions
- Receive adjuvant treatments like targeted therapy, endocrine therapy or local radiotherapy following clinical practice guidelines
- Attend clinic follow-up visits every 6 months for 2 years after surgery, including physical exams, surgical site checks and upper limb circumference measurements
- Allow their clinical, surgical, pathological and follow-up data to be collected and entered into a dedicated research database Report any physical discomfort or adverse events that occur during the study period to the research medical team in a timely manner
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESLNB group | Experimental | Procedure: ESLNB |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female treatment-naive breast cancer patients aged 18 to 70 years old.
- Histopathologically confirmed invasive breast cancer, either early-stage (T1-2N0-1M0, Stage Ⅰ-Ⅱ) or locally advanced (T3N0-1M0/T1-3N1M0, Stage ⅢA) as defined by the latest ASCO/CAP guidelines; initial clinical axillary stage cN0-1 with pathologically confirmed axillary lymph node positivity via needle biopsy.
- Voluntarily accept a complete course of standard neoadjuvant therapy for 6 or 8 cycles, and achieve clinical axillary node negativity (cN0) in axillary lymph node re-evaluation by ultrasound after completion of neoadjuvant therapy.
- Willing to undergo neoadjuvant therapy plus methylene blue single tracer-guided extensive sentinel lymph node biopsy combined with axillary lymph node dissection.
- Voluntarily participate in the study and sign the informed consent form.
Key exclusion criteria (5 listed)
- Patients over 70 years old.
- Newly diagnosed metastatic breast cancer (Stage Ⅳ).
- Gestational breast cancer patients.
- Patients with abnormal function of vital organs (heart, lung, liver, kidney) or poorly controlled diabetes, who are unable to tolerate surgery.
- Other conditions that the investigator deems unsuitable for study participation.
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 |
|---|---|---|
| ESLNBFirst, personalized breast surgery is performed in accordance with the patient's breast tumor condition (e.g., breast-conserving surgery, modified radical mastectomy). Next, blue-stained lymphatic vessels are dissected and identified to locate and resect the primary sentinel lymph nodes (SLNs). Subsequently, the lymphoid tissue in the extensive sentinel lymph node region (2-3cm around the resected SLNs) is completely excised (defined as ESLNB in this study). Finally, systematic dissection and clearance of the remaining axillary lymph node regions are conducted to complete ALND. Post-surgical wound management: The surgical wound is rinsed and soaked successively with sterile distilled water and normal saline for hemostasis; a drainage tube is placed, and the skin is sutured layer by layer in accordance with standard surgical protocols. | Procedure or surgery | ESLNB group |
Primary outcome
The false negative rate of extended sentinel lymph node biopsy.
Time frame: Two weeks after the operation
A false negative is defined as follows: after the extended sentinel lymph node biopsy indicates a negative result, metastasis is still found in the subsequently examined axillary lymph nodes.
3 secondary outcomes
The false negative rate of sentinel lymph node biopsy
Time frame: Two weeks after the operation
The detection rate of extended sentinel lymph node dissection
Time frame: Two weeks after the operation
The incidence rate of upper limb lymphedema
Time frame: Half a year after the operation, one year after the operation, two years after the operation
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 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESLNB in people with Breast Cancer, run by Xijing Hospital 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 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The false negative rate of extended sentinel lymph node biopsy. (time frame: Two weeks after the operation). 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 16 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.