Extended Sentinel Lymph Node Biopsy With Methylene Blue Single Tracer Post-Neoadjuvant Therapy for Node-Positive Breast Cancer

April 8, 2026 updated by: Xijing Hospital

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?

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESLNB group
Procedure: ESLNB

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two weeks after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The false negative rate of sentinel lymph node biopsy
Time Frame: Two weeks after the operation
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
Two weeks after the operation
The detection rate of extended sentinel lymph node dissection
Time Frame: Two weeks after the operation
Number of lymph nodes detected through preoperative sentinel lymph node dissection
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
The patients develop lymphedema in the arm on the surgical side after the breast cancer surgery.
Half a year after the operation, one year after the operation, two years after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 25, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 15, 2028

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20262066-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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