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Study identifier: NCT07469267 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Level I-II Axillary Irradiation in Breast Cancer With Sentinel-Node Macro-metastases

Condition: Breast Cancer · Radiotherapy  ·  Sponsor: Fudan University

PhaseNA
Planned participants1608
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Xiaoli Yu, MD, PhD  ·  +86-13817893133  ·  xiaoliyu@fudan.edu.cn

Li Zhang, M.D.  ·  +86-18121299516  ·  lizhang_@fudan.edu.cn

Always discuss trial participation with your own doctor first.

Locations (15)

Oncology Department, Guizhou Provincial People's HospitalGuiyang, Guizhou, ChinaNot Yet Recruiting
The Fourth Hospital of Hebei Medical UniversityShijiazhuang, Hebei, ChinaNot Yet Recruiting
Harbin Medical University Cancer HospitalHarbin, Heilongjiang, ChinaNot Yet Recruiting
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, Hubei, ChinaNot Yet Recruiting
Department of Radiation and Medical Oncology,Zhongnan Hospital of Wuhan UniversityWuhan, Hubei, ChinaNot Yet Recruiting
Changde Hospital, Xiangya school of Medicine, Central South University (The first people's hospital of Changde city)Changde, Hunan, ChinaNot Yet Recruiting
Hunan cancer hospital/The affiliated cancer hospital of xiangya school of medicine,Central South universityChangsha, Hunan, ChinaNot Yet Recruiting
Department of Radiation and Medical Oncology, Affiliated Zhongshan Hospital of Dalian UniversityDalian, Liaoning, ChinaNot Yet Recruiting
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)Jinan, Shandong, ChinaNot Yet Recruiting
Fudan University Shanghai Cancer CenterShanghai, Shanghai Municipality, ChinaRecruiting
Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineShanghai, Shanghai Municipality, ChinaNot Yet Recruiting
Tianjin Medical University Cancer Institute and HospitalTianjin, Tianjin Municipality, ChinaNot Yet Recruiting

+ 3 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07469267