Status:
RECRUITING
Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Sentinel Lymph Node Biopsy
Eligibility:
All Genders
18-70 years
Brief Summary
SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long...
Detailed Description
SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long...
Eligibility Criteria
Inclusion
- Patients With ECOG Score 0-1 Points
- 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
- Patients With Abnormal Axillary Lymph Nodes ≤ 3 Detected by Imaging Examination
- Patients With Effective Neoadjuvant Therapy (CR+PR)
- Patients With Clinical Axillary Negative ycN0 After Neoadjuvant Therapy
- Patients Without Prior History of Ipsilateral Axillary Surgery and Radiation Therapy
- Patients Without Previous History of Ipsilateral Breast Cancer (Including Carcinoma in Situ)
- Patients Without Obvious Contraindications for Surgery or Radiation Therapy
- No Other History of Malignant Tumors Within 5 Years From Enrollment in the Study
- 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
- The patient voluntarily joined this study and signed an informed consent form.
Exclusion
- Stage IV (metastatic) breast cancer；
- Simultaneous double breast cancer；
- Baseline cT4;
- Baseline cN2-3
- gestation
- There are contraindications for SLNB;
- 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
Key Trial Info
Start Date :
April 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT06518135
Start Date
April 30 2024
End Date
March 31 2028
Last Update
December 17 2024
Active Locations (1)
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1
Henan cacer hospital
Henan, Henan, China, 450008