NCT07498400

Exemption of SLNB After Neoadjuvant Therapy for Triple-negative and Her2-positive Breast Cancer

A Multicenter, Randomized Controlled Study on the Exemption of Sentinel Lymph Node Biopsy After Neoadjuvant Therapy for Triple-negative and Her2-positive Breast Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The neoadjuvant system therapy (NAST) can significantly increase the pathological complete response (pCR) rate for patients with triple-negative (TNBC) and HER2-positive breast cancer. Some patients can achieve complete disappearance of the tumor or only residual tumors ≤ 2 cm in preoperative imaging examinations (mammography, ultrasound or MRI), which is defined as clinical complete response (cCR). The traditional surgical approach still requires sentinel lymph node biopsy (SLNB) even for cCR cases to rule out axillary metastasis. However, the association of SLNB with complications such as lymphedema, pain, and limited shoulder joint function has been confirmed in multiple retrospective cohorts, significantly reducing the quality of life of patients. Current guidelines (such as ASCO 2025, SOUND, INSEMA) propose that SLNB can be omitted in low-risk populations, but these recommendations are mainly based on postoperative pathological information (pCR) or overall survival (OS)/progression-free survival (DFS), and lack high-level evidence for the direct assessment of axillary lymph node recurrence rate (AR). Therefore, there is an urgent need to conduct prospective, randomized controlled trials to clarify whether omitting SLNB will lead to an increase in axillary recurrence in T1-2 N0 triple-negative or HER2-positive breast cancer patients who achieve cCR after neoadjuvant treatment. The results of this study will provide evidence-based support for surgical de-radication, potentially significantly reducing surgical-related complications, saving medical resources, and improving the quality of life of patients.

Conditions

• Breast Cancer (Triple Negative Breast Cancer (TNBC))
• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Exemption of SLNB	Breast-conserving surgery (or mastectomy) without sentinel lymph node biopsy (SLNB). Postoperatively, conventional radiotherapy (for breast-conserving therapy), endocrine (HR+) immunotherapy (for triple-negative cases), or HER2-targeted (HER2+) treatment is received.

Timeline

• Start date: 2026-01-01
• Primary completion: 2030-12-31
• Completion: 2031-03-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China