Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer

Henan Cancer Hospital

Status: Enrolling

Conditions: Sentinel Lymph Node Biopsy

Treatments: Other: SLNB group

Study type: Observational

Funder types: Other

Identifiers

NCT06518135

2024-157

Details and patient eligibility

About

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.

Full 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-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. The main endpoint of the study was axillary recurrence free survival. The secondary study endpoints were regional lymph node recurrence free survival, disease-free survival, overall survival, incidence of postoperative upper limb lymphedema, and patient quality of life.

Enrollment: 508 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

508 participants in 1 patient group

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.

Treatment:

Other: SLNB group