About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- regional nodal irradiation
- WBI
- chestwall XRT
Treatment groups
Sponsors and collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
Sun Yat-sen University
Collaborator