An interventional study of Whole breast irradiation and Whole breast and nodal irradiation in Breast Neoplasm, sponsored by Samsung Medical Center. Active, not recruiting at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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:
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 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.
Exclusion Criteria:
Post-lumpectomy radiotherapy to the whole breast alone.
Radiation: Whole breast irradiation
Post-lumpectomy radiotherapy to the whole breast and regional lymph node.
Radiation: Whole breast and nodal irradiation
Radiotherapy to the whole breast alone.
Radiotherapy to the whole breast and regional lymph nodes.
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Samsung Medical Center