Evaluating Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Breast Cancer Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the optimal technical pathway and long-term tumor safety of axillary sentinel lymph node biopsy (SLNB) in patients with initial cN1 breast cancer who have undergone neoadjuvant chemotherapy and have downgraded to ycN0. The study will focus on evaluating axillary recurrence-free survival as the primary endpoint, while secondary endpoints include regional lymph node recurrence-free survival, disease-free survival, overall survival, incidence of postoperative upper limb lymphedema, and patient quality of life. By analyzing real-world data, the study seeks to clarify the best practices for SLNB in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients With ECOG Score 0-1 Points
2. Patients With Breast Cancer Stage cT1-3N1M0 (According to AJCC Version 7) Pathological Diagnosis of Ipsilateral Axillary Lymph Node Metastasis in Patients With Invasive Breast Cancer
3. Patients With Abnormal Axillary Lymph Nodes ≤ 3 Detected by Imaging Examination
4. Patients With Effective Neoadjuvant Therapy (CR+PR)
5. Patients With Clinical Axillary Negative ycN0 After Neoadjuvant Therapy
6. Patients Without Prior History of Ipsilateral Axillary Surgery and Radiation Therapy
7. Patients Without Previous History of Ipsilateral Breast Cancer (Including Carcinoma in Situ)
8. Patients Without Obvious Contraindications for Surgery or Radiation Therapy
9. No Other History of Malignant Tumors Within 5 Years From Enrollment in the Study
10. Patients Who Participate in Other Clinical Trials at the Same Time and Are Judged by the Researchers Not to Affect the Study Protocol Can be Enrolled Normally
11. The patient voluntarily joined this study and signed an informed consent form.

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer；
2. Simultaneous double breast cancer；
3. Baseline cT4;
4. Baseline cN2-3
5. gestation
6. There are contraindications for SLNB;
7. Suffering from serious comorbidities or other comorbidities that may interfere with the planned treatment, or any other circumstances in which the researcher deems the patient unsuitable to participate in this study

Where it's running

• Henan cacer hospital
  Henan, Henan, China Recruiting

Study contacts

• Principal investigator: Zhenzhen Liu — Henan Cancer Hospital
• Study coordinator: Zhenzhen Liu
• Email: liuzhenzhen73@126.com
• Phone: 0371-65587005

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.