The purpose of this study is to validate whether clinically low-risk, and RecurIndex high-risk N1 patients receiving regional lymph node radiotherapy can further improve clinical outcomes.
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, a）Age ≥ 40 years old, b）Vascular tumor thrombus (LVI) negative or allow few positive LVI (excluding extensive or massive LVI), c）Three subtypes are allowed (Lumina A, Lumina B/HER2 negative, Lumina B/HER2 positive) , namely ER positive (ER ≥ 1%), HER2 negative (HER2 expression negative or + by IHC, or 2+ but negative by FISH) or ER positive (ER ≥ 1%), HER2 positive (3+ by IHC, or 2+ but positive by FISH).
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.
Parallel
regional nodal irradiation
Radiationexternal-beam radiotherapy (XRT)
WBI
RadiationWhole Breast Irradiation
chestwall XRT
Radiationchestwall irradiation
Invasive disease-free survival (IDFS)
defined as the time between randomization and either local recur, 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
Distant metastasis free survival (DMFS)
defined as time between randomization and the time of 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
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
Sun Yat-sen University
Collaborator
