Clinical trial · Observational
Radiotherapy and Long-term Outcomes in Early Breast Cancer With SLNB Omission
A Prospective Cohort Study of Radiotherapy Characteristics and Long-term Outcomes in Early Breast Cancer Omitting Sentinel Lymph Node Biopsy: The APROOB Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Early-Stage Invasive Breast Carcinoma | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Breast Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- APROOB Cohort
- description
- 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 according to routine clinical practice. Radiotherapy may include whole-breast or partial-breast irradiation, with treatment characteristics determined by the treating physician and participating institution.
- interventionNames
- Radiation: Adjuvant Breast Radiotherapy
Primary outcomes (1)
- measure
- 5-Year Recurrence-Free Survival Rate
- timeFrame
- From study enrollment to 5 years
- description
- 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.
Secondary outcomes (10)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available