Axillary Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes

Study Overview
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Brief Summary
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This study is designed to evaluate the feasibility and safety of axillary radiotherapy for early stage breast cancer with limited positive sentinel lymph nodes.

Detailed Description
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Randomized clinical trials have demonstrated that complete axillary lymph node dissection is not necessary in patients with 1-2 positive sentinel lymph nodes who undergo breast conserving surgery, whole breast irradiation, and systemic therapy. However, whether or not the regional lymph node should be irradiated and if radiation given, whether or not all levels of axillary lymph node and internal mammary and supraclavicular lymph node should be irradiated is unknown. The purpose of this study is to evaluate the feasibility and safety of axillary level I-II areas radiotherapy for early stage breast cancer with 1-2 positive sentinel lymph nodes and no further axillary lymph node dissection.

Official Title
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Phase II Study of Axillary Level I-II Areas Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: axillary radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Axillary radiotherapy<br> | Radiation: axillary radiotherapy<br>* Whole breast irradiation and axillary level I-II areas radiotherapy. The prescription dose is 50Gy in 25 fractions in 5 weeks. Tumor bed boost is necessary with 10Gy in 5 fractions in one week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axillary recurrence |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local-regional recurrence |  | 5 years | 
| Disease free survival |  | 5 years | 
| Overall survival |  | 5 years | 
| Complications |  | baseline，1，2，3，4，5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, positive sentinel lymph nodes, axillary radiotherapy