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

NCT07532096 | Not Yet Recruiting DMC

• 1 other identifier: KY20262066-F-1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Breast Cancer

Keywords

Breast cancer; Extensive sentinel lymph node biopsy; Methylene blue

Outcome Measures

Primary Outcomes (1)

• 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.

  Two weeks after the operation

Secondary Outcomes (3)

• The false negative rate of sentinel lymph node biopsy

  Two weeks after the operation

• The detection rate of extended sentinel lymph node dissection

  Two weeks after the operation

• The incidence rate of upper limb lymphedema

  Half a year after the operation, one year after the operation, two years after the operation

Study Arms (1)

ESLNB group

EXPERIMENTAL

Procedure: ESLNB

Interventions

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.

ESLNB group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ju liang Zhang

CONTACT

02984775271; vascularzhang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): April 25, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 15, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

CN (1)