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
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.
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.
Single group
ESLNB
Procedure/SurgeryFirst, 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.
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.
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
The detection rate of extended sentinel lymph node dissection
Number of lymph nodes detected through preoperative sentinel lymph node dissection
The incidence rate of upper limb lymphedema
The patients develop lymphedema in the arm on the surgical side after the breast cancer surgery.
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