Clinical trial · Observational
Axillary Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes
Phase II Study of Axillary Level I-II Areas Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes
NCT02612012CI-TRIAL-00019913unknownClinicalTrials.gov clinicaltrialsProvenance
- 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 study is designed to evaluate the feasibility and safety of axillary radiotherapy for early stage breast cancer with limited positive sentinel lymph nodes.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| axillary radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Axillary radiotherapy
- interventionNames
- Radiation: axillary radiotherapy
Primary outcomes (1)
- measure
- Axillary recurrence
- timeFrame
- 5 years
Secondary outcomes (4)
- measure
- Local-regional recurrence
- timeFrame
- 5 years
- measure
- Disease free survival
- timeFrame
- 5 years
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female * 18\~70 years old * Pathologically confirmed invasive breast cancer * A clinical T1-2N0M0 tumor * Treated with breast conserving surgery and sentinel lymph node biopsy * 1\~2 positive sentinel lymph nodes, including micro-metastases or macro-metastases. * ECOG score 1\~2 * Written informed consent Exclusion Criteria: * Patients underwent complete axillary lymph node dissection * Patients underwent mastectomy * Patients underwent neoadjuvant therapy * Clinically node positive pre-operative * Sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm) * Prior history of invasive breast cancer or previous or concurrent other malignancies within the past 5 years * Previous radiation therapy of breast or thorax * Medical contraindication for radiotherapy * Prior axillary surgery or radiotherapy * Unable or unwilling to receive breast conserving surgery or sentinel lymph node biopsy * Pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.