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NCT Number: NCT07532096

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESLNB

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ju liang Zhang

CONTACT

[email protected]

02984775271

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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