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

• Conditions: Breast Cancer
• Interventions: Radiation: axillary radiotherapy

• Registration Number: NCT02612012
• Lead Sponsor: Fudan University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-10
• Status Verified: 2015-11
• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-20
• Last Update Submitted: 2015-11-20
• Study First Posted: 2015-11-23
• Last Update Posted: 2015-11-23
• Primary Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 475

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Axillary radiotherapy	axillary radiotherapy	-

Primary Outcome Measures

Name	Time	Method
Axillary recurrence	5 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years
Complications	baseline，1，2，3，4，5 years
Local-regional recurrence	5 years
Disease free survival	5 years

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China