Breast cancer after breast-conserving surgery without sentinel node biopsy: radiotherapy outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter observational cohort collects data on long-term outcomes for patients with early-stage invasive breast cancer who omit sentinel lymph node biopsy and receive adjuvant radiotherapy after breast-conserving surgery. Radiotherapy type, dose, and techniques will be recorded in detail to explore associations with recurrence, survival, toxicities, and quality of life, without prescribing a specific treatment plan. The study aims to describe real-world practice and how variations in radiotherapy after SLNB omission relate to outcomes. No radiotherapy protocol is mandated; treatments follow routine clinical practice at participating sites. The APROOB Cohort seeks to understand whether omitting SLNB combined with diverse radiotherapy approaches yields acceptable long-term results.

Why it matters

Who can join: the full rules

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's running

• Samsung Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Haeyoung Kim
• Email: haeyoung0131.kim@samsung.com
• Phone: +82234102612

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.