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Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer: Non-randomized Phase II, Prospective Single Arm Study Clinical Trial
The purpose of the study is to evaluate treatment outcomes of breast cancer with internal mammary or supraclavicular lymph node metastasis according to total radiation dose of postoperative radiation therapy differentiated by tumor response to neoadjuvant chemotherapy. The main questions it aims to answer are: * 5-year disease-free survival * 5-year overall survival * 5-year locoregional recurrence * Adverse events after radiation therapy * Quality of life Participants will be assessed by multi-dimensional methods before and after radiotherapy: * Disease status evaluation including physical and radiological examination * Quality of life assessment with questionnaires (BREAST-Q) * Adverse event assessment according to CTCAE version 5.0
Age
19 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Samsung Medical Center
Seoul, South Korea
Start Date
March 16, 2023
Primary Completion Date
March 16, 2028
Completion Date
March 16, 2030
Last Updated
June 29, 2025
120
ESTIMATED participants
Whole breast / chest wall & regional lymph node irradiation
RADIATION
Internal mammary or supraclavicular lymph node boost
RADIATION
Lead Sponsor
Samsung Medical Center
NCT06806930
NCT07188246
Data Source & Attribution
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