NCT07803081 Radiotherapy and Long-term Outcomes in Early Breast Cancer With SLNB Omission
| NCT ID | NCT07803081 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-08-06 |
| Primary Completion | 2036-08-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2026-08-06 with a primary completion date of 2036-08-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07803081 clinical trial?
This trial is open to female participants only, aged 19 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07803081 currently recruiting?
Yes, NCT07803081 is actively recruiting participants. Contact the research team at haeyoung0131.kim@samsung.com for enrollment information.
Where is the NCT07803081 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07803081 clinical trial?
NCT07803081 is sponsored by Samsung Medical Center. The trial plans to enroll 500 participants.
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