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

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later May 1, 2027 → May 1, 2028
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Record History

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  1. Notable Primary completion pushed from May 1, 2027 to May 1, 2028 Show 6 more changesShow less
    • Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Study completion pushed from May 15, 2028 to May 15, 2029
    • Start date changed from estimate of Apr 25, 2026 to May 3, 2026
    • Eligibility criteria expanded, about 10 words
    • Study description expanded, about 7 words
    • Site contact updated
  2. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
179 trials monitored
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5,455 trials monitored
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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
Trial Details
NCT Number NCT07532096
Lead Sponsor Xijing Hospital
Conditions
(from sponsor)
Breast Cancer
Related terms Breast Neoplasms
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov