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RECRUITING
NCT07803081

Radiotherapy and Long-term Outcomes in Early Breast Cancer With SLNB Omission

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

Summary

This prospective, multicenter observational cohort study evaluates long-term outcomes in patients with early-stage invasive breast cancer who undergo breast-conserving surgery without sentinel lymph node biopsy or other axillary surgery and subsequently receive adjuvant radiotherapy. The study will evaluate recurrence, survival, radiotherapy-related toxicities, and quality of life. Radiotherapy will be delivered according to routine clinical practice at each participating institution without protocol-mandated treatment assignment. Detailed radiotherapy characteristics, including treatment volume, technique, dose and fractionation, tumor-bed boost, and radiation dose to axillary lymph node levels I-III, will be prospectively collected to evaluate their associations with clinical outcomes.

Official title: A Prospective Cohort Study of Radiotherapy Characteristics and Long-term Outcomes in Early Breast Cancer Omitting Sentinel Lymph Node Biopsy: The APROOB Cohort Study

Key Details

Gender

FEMALE

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2026-08-06

Completion Date

2036-08-05

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

RADIATION

Adjuvant Breast Radiotherapy

Adjuvant radiotherapy is delivered after breast-conserving surgery according to routine clinical practice at each participating institution. Radiotherapy may include whole-breast irradiation or partial-breast irradiation, with treatment technique, dose, fractionation, and tumor-bed boost determined by the treating physician. The study does not assign or mandate a specific radiotherapy regimen.

Locations (1)

Samsung Medical Center

Seoul, South Korea