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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 5-Year Recurrence-Free Survival Rate — From study enrollment to 5 years
  Recurrence-free survival is defined as the time from study enrollment to the first occurrence of ipsilateral invasive breast recurrence, ipsilateral regional lymph node recurrence, distant metastasis, or breast cancer death. The 5-year recurrence-free survival rate will be estimated using the Kaplan-Meier method.

Trial sites (1)

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