Actively Recruiting
Level I-II Axillary Irradiation in Breast Cancer With Sentinel-Node Macro-metastases
Led by Fudan University · Updated on 2026-03-13
1608
Participants Needed
15
Research Sites
531 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The RELAX trial is an open-label, multicenter, non-inferiority, randomized, phase 3 clinical trial. Multiple randomized trials have demonstrated the safety of omitting complete axillary-lymph-node dissection in patients with invasive breast cancer and limited sentinel lymph node metastases. However, the necessity and optimal extent of regional nodal irradiation remains uncertain. The aim of this study is to evaluate whether level I-II axillary irradiation is non-inferior to whole regional nodal irradiation in terms of disease-free survival in clinically node-negative breast cancer patients with 1-2 sentinel lymph node macro-metastases.
CONDITIONS
Official Title
Level I-II Axillary Irradiation in Breast Cancer With Sentinel-Node Macro-metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female 18 years of age or older
- Newly diagnosed primary invasive breast cancer
- Clinically stage T1-3N0M0
- Received surgery as first treatment with breast conserving surgery or mastectomy and negative margins
- Have one or two macrometastases (>2 mm) at sentinel lymph node biopsy without further axillary lymph node dissection
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Planned endocrine therapy for at least 5 years if estrogen and/or progesterone receptor positive
- Planned anti-HER2 therapy for 1 year if HER2 positive
- Radiation therapy to start no later than 12 weeks after last chemotherapy dose or surgery
- Adequate organ function
- Provided informed consent
You will not qualify if you...
- Received neoadjuvant systemic therapy
- Clinical stage T4 or IV breast cancer or presence of regional metastases before surgery
- History of any prior invasive breast cancer or other malignancies except treated skin basal cell carcinoma and cervical carcinoma in situ
- Prior radiotherapy to ipsilateral chest or lymph nodes
- Prior ipsilateral axillary lymph node dissection or other axillary surgery
- Current severe uncontrolled systemic disease or inability to tolerate treatments
- Current pregnancy or lactation
- Unable or unwilling to comply with study protocol requirements
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Oncology Department, Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Not Yet Recruiting
2
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Not Yet Recruiting
3
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Not Yet Recruiting
4
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
5
Department of Radiation and Medical Oncology，Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Not Yet Recruiting
6
Changde Hospital, Xiangya school of Medicine, Central South University (The first people's hospital of Changde city)
Changde, Hunan, China
Not Yet Recruiting
7
Hunan cancer hospital/The affiliated cancer hospital of xiangya school of medicine,Central South university
Changsha, Hunan, China
Not Yet Recruiting
8
Department of Radiation and Medical Oncology, Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
Not Yet Recruiting
9
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
Jinan, Shandong, China
Not Yet Recruiting
10
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
11
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
12
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
13
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Not Yet Recruiting
14
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
15
Department of Chemoradiation Oncology, The Affiliated Lihuili Hospital of Ningbo University
Ningbo, Zhejiang, China
Not Yet Recruiting
Research Team
X
Xiaoli Yu, MD, PhD
CONTACT
L
Li Zhang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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