This study evaluates the impact of elective regional lymph node irradiation on N1 breast cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane (AT)-based chemotherapy. We randomly assign patients having one to three metastatic lymph nodes (pN1) after breast-conserving surgery (BCS) and AT-based chemotherapy to undergo either whole-breast and regional nodal irradiation (WB+RNI group) or whole-breast irradiation alone (WBI group).
Objective: * Compare the effect of post-BCS WBI vs. WB+RNI on disease-free survival in pN1 breast cancer patients who received AT-based chemotherapy. * Evaluate the impact of WBI or WB+RNI according to molecular subtype of tumor. * Compare the treatment-related toxicities between the WBI and WB+RNI. * Compare the patient's quality of life between the WBI and WB+RNI. Outline: This is a a randomized, multi-center, phase III study. Patients are stratified according to molecular subtype of tumor (luminal A vs luminal vs luminal HER2 vs HER2-enriched vs basal-like), axillary lymph node management (sentinel lymph node biopsy \[SLN\] only vs axillary lymph node dissection+/- SLN) and participating institutions. Patients are randomized to one of two treatment arms. * Arm I: Patients receive WB+RNI. * Arm II: Patients receive WBI alone. Arm circumference and quality of life (EORTC QLQ-C30 \& EORTC QLQ-BR23) are assessed within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 months after completion of radiotherapy, and then annually thereafter for five years. Patients are followed at 3 months after completion of radiotherapy and annually thereafter for seven years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
827
Radiotherapy to the whole breast alone.
Radiotherapy to the whole breast and regional lymph nodes.
Samsung Medical Center
Seoul, South Korea
Disease-free survival
Disease-free survival
Time frame: 7 years
Disease-free survival according to molecular subtype
Disease-free survival according to molecular subtype
Time frame: 5 years
Treatment-related toxicity
acute and chronic toxicities
Time frame: 5 years
European Organization for Research and Treatment of Cancer (EORTC)-Quality of life. Questionnaire 30 (QLQ-C30) measurement
1 (Not at all) to 4 (Very much), 1 (Very poor) to 7 (Excellent). For functional and global quality of life scales, higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.
Time frame: 5 years
EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23) measurement
1 (Not at all) to 4 (Very much). A higher score means more severe symptoms.
Time frame: 5 years
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