NCT06518135

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 508 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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-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.

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-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.

Conditions

• Sentinel Lymph Node Biopsy

Interventions

Type	Name	Description
OTHER	SLNB group	After the completion of neoadjuvant therapy, axillary SLNB should be performed first before breast surgery; If the frozen pathology SLNs are negative, ALND will no longer be performed; If frozen pathological SLNs are positive, ALND should be performed directly; If frozen pathology is false negative.

Timeline

• Start date: 2024-04-30
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2024-07-24
• Last updated: 2024-12-17

Locations

1 site across 1 country: China