The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial
This study is a multicenter, randomized, phase 3 clinical trial in patients with breast cancer, randomizing radiotherapy group (postmastectomy radiation therapy (PMRT)/whole breast irradiation plus regional radiotherapy (WBI+regional RT) versus and no PMRT/WBI alone group. This is a non-inferiority study aiming that there is no significant difference in the 7-year disease-free survival rate between the two groups.
• Patients aged 19 years or older.
• A female patient who underwent breast-conserving surgery or mastectomy for invasive breast cancer.
• Patient with stage pN1 after surgery on histopathologic examination.
⁃ However, if mastectomy was performed, 5 or more nodes should be resected in the case of 1 positive node, and axillary lymph node dissection (ALND) should be performed in case of 2 or 3 positive nodes.
• Patients undergoing or planning to undergo hormone therapy in the case of hormone receptor positive.
• Patients who have received or are expected to undergo targeted therapy in the case of human epidermal growth factor receptor(HER)-2 positive.
• Patients with Eastern Cooperative Oncology Group (ECOG) Scale 0-2.
• Patients who agreed to participate in the study.