The purpose of this study is to determine whether certain patients can safely omit regional lymph node radiotherapy. These women must have hormone-sensitive, Her2-negative tumors, have 1-3 positive axillary nodes and have RecurIndex low-risk.
Age ≥ 18 years old, ≤ 70 years old.
Eastern Cooperative Oncology Group (ECOG) ≤ 2.
Postoperative pathology is clearly diagnosed as invasive breast cancer. Meet the clinical definition of low risk: ①Axillary lymph node micrometastasis (N1mic) or ②N1 patients who meet the following conditions at the same time,
Postoperative pathological diagnosis of axillary lymph node status is any of the following: a. Sentinel lymph node biopsy or axillary lymph node dissection for micrometastasis (N1mic), b. Sentinel lymph node biopsy for 1-2 lymph node macrometastasis (N1sln), c. Sentinel lymph node biopsy + axillary lymph node dissection or simple axillary lymph node dissection for 1-3 lymph node metastasis (N1).
Postoperative radiotherapy was confirmed as T3-4, N0, N2-3, M1 lesion staging before enrollment.
Receive any new adjuvant therapy before surgery, including chemotherapy, endocrine therapy, targeted therapy or radiation therapy.
Patients who underwent total mastectomy and only sentinel lymph node biopsy.
Have a history of contralateral breast cancer.
pT1-2N1M0 breast cancer
Cohort
Prospective
Omission of Regional Radiotherapy
Procedure/SurgeryOmission of Regional Radiotherapy
Local-regional recurrence rate
defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Any first recurrence (AFR)
defined as any recurrence of ipsilateral chest, breast, regional lymph node recurrence, or distant metastases by Imaging or pathology
Local-regional recurrence free survival (LRFS)
defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Recurrence free survival (RFS)
defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Disease free survival (DFS)
defined as time between randomization and the time of disease recur or death occur
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
Sun Yat-sen University
Collaborator