Radiotherapy and Long-term Outcomes in Early Breast Cancer With SLNB Omission
Recruiting · NCT07803081 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Female patients aged 19 years or older with histologically confirmed invasive breast cancer
- Patients who have undergone breast-conserving surgery with curative intent
- Patients who did not undergo axillary lymph node surgery, including sentinel lymph node biopsy, at the time of breast cancer surgery
- No evidence of distant metastasis on clinical and imaging evaluation before surgery
- Planned to receive adjuvant radiotherapy after breast-conserving surgery
- Ability and willingness to provide written informed consent before study participation
Exclusion criteria
- Patients initially diagnosed with breast carcinoma in situ before surgery who did not undergo sentinel lymph node biopsy but were subsequently found to have invasive breast cancer on final surgical pathology
- Receipt of neoadjuvant systemic therapy before breast cancer surgery
- History of a malignancy other than breast cancer within 5 years before study enrollment, except adequately treated non-melanoma skin cancer or carcinoma in situ other than breast carcinoma in situ
- Recurrent breast cancer
- Bilateral breast cancer or inflammatory breast cancer
- Prior radiotherapy to the ipsilateral breast or chest region
- Patients considered by the investigator to be unsuitable for study participation or long-term follow-up
Where it is running
1 location listed.
- Samsung Medical Center - Seoul, South Korea