Clinical trial · Observational
Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer
Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer: a Prospective, Multicenter, Single Arm, Real World Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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-term tumor safety data is still insufficient. Therefore, it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real world.This study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sentinel Lymph Node Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SLNB group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- SLNB group
- description
- Standard sentinel lymph node biopsy group, if frozen pathology SLNs are negative, no ALND will be performed; If frozen pathological SLNs are positive, ALND should be performed directly; If the frozen pathology is false negative, it is recommended to complete ALND within 12 weeks after SLNB surgery.
- interventionNames
- Other: SLNB group
Primary outcomes (1)
- measure
- Axillary recurrence-free survival
- timeFrame
- 5th year after surgery
- description
- The time from surgery to axillary recurrence or last follow-up
Secondary outcomes (5)
- measure
- regional lymph node recurrence-free survival
- timeFrame
- 5th year after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available