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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
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.
Xijing Hospital
Xi'an, China
Efficacy Measurement
3-year AR (axillary recurrence rate): Axillary lymph node metastasis (stage I - III) confirmed by imaging (US/MRI/CT) or pathology within 3 years after surgery; not included in distant metastasis
Time frame: 3 years
DFS
The time from the subject's enrollment to the first occurrence of a recurrent disease. Recurrent diseases include recurrence on the same side or on the opposite side of the breast, local or regional recurrence, distant recurrence, and any death caused by
Time frame: 3 years
OS
The time from enrollment to death due to any cause.
Time frame: 3 years
Complications
Surgery-related complications (lymphedema, pain, limited shoulder function)
Time frame: 3 years
QLQ C30
Changes in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C30). The assessment form consists of 30 items. Each item is scored from 1 to 4 points. The higher the score, the more severe the symptoms and the poorer the quality of life.
Time frame: 3 years
ICER
Cost-effectiveness (ICER)
Time frame: 3 years
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