Omission of ALND in Breast Cancer Patients With Axillary pCR
Axillary Lymph Node Dissection, Pathological Complete Response, Neoadjuvant Systemic Therapy
About this trial
This is an interventional treatment trial for Axillary Lymph Node Dissection focused on measuring Breast Cancer, Neoadjuvant Systemic Therapy, Axillary Surgery
Eligibility Criteria
Inclusion Criteria: Female aged between 18 and 70 years; Pathologically confirmed invasive breast cancer (regardless of pathological type) with a clinical stage cT1-3; Pathologically confirmed positive axillary lymph nodes with a clinical stage of N1-3; Receiving a full course of neoadjuvant therapy (including neoadjuvant chemotherapy, neoadjuvant targeted therapy, neoadjuvant immunotherapy); Positive axillary lymph nodes successfully stained by carbon nanoparticles injection with/without titanium clip marking; All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki- 67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases; Preoperative clinical assessment (including physical examination, imaging, with or without nomogram assessment) suggests positive axillary lymph nodes converted to negative (ycN0); ECOG score 0 - 1; Patients voluntarily participated in this study and signed the informed consent form Exclusion Criteria: Bilateral breast cancer; Breast cancer during lactation period or pregnancy; Physical examination or imaging examination confirmed presence of distant metastases; Previous history of malignant tumor; History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity; History of radiation therapy to the breast or chest; Positive incision margins for breast-conserving surgery/mastectomy; Positive results of intraoperative rapid freeze pathology (including isolated tumor cells and micrometastases) for SrLNB (ypN+); Those who unable to complete the full course of follow-up adjuvant therapy as prescribed for various reasons; Aspartate transaminase (AST) and alanine transaminase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase(ALP) ≥ 2.5 times the upper limit of normal, total bile ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; Left Ventricular Ejection Fractions (LVEF) < 50% in cardiac ultrasound; Severe coagulation dysfunction, serious systemic disease, or uncontrolled infection; Without personal freedom and independent civil capacity; Those with mental disorders, addictions, who were not eligible for enrollment in the judgment of the investigator.
Sites / Locations
- The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Experimental
Omit ALND
Omitting Axillary Lymph Node Dissection (ALND) in SrLNB-proven axillary complete response patients. Finishing regional lymph node irradiation (RNI) including the axilla after surgery.