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

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Radiotherapy

In brief

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.

Key facts

Study ID

NCT07469267

Run by

Fudan University

People needed

1608

Starts

2025-10-24

Expected to finish

2035-12-31

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female ≥ 18 years of age;
• Newly diagnosed primary invasive breast cancer;
• Clinically stage T1-3N0M0;
• Patients received surgery as first treatment,and have undergone breast conserving-surgery or mastectomy (with or without breast reconstruction) with negative margins;
• Have one or two macrometastases (>2 mm) at sentinel lymph node biopsy,and without further axillary lymph node dissection;
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
• Will receive endocrine therapy for at least 5 years for estrogen receptor (ER) and/or progesterone receptor (PR) positive patients; will receive anti-HER2 (human epidermal growth factor receptor 2) therapy for 1 year for HER2 positive patients;
• Radiation therapy must begin no later than 12 weeks after the last dose of adjuvant chemotherapy or the last breast cancer surgery if no adjuvant chemotherapy;
• Patients have adequate organ function;
• Acquirement of informed consent.

You may not qualify if…

• Patients have received neoadjuvant systemic therapy;
• Clinical stage T4 or IV (metastatic) breast cancer, or presence of regional metastases before surgery;
• History of any prior ipsilateral or contralateral invasive breast cancer, history of other malignancies except for appropriately treated skin basal cell carcinoma and cervical carcinoma in situ;
• History of previous radiotherapy towards the ipsilateral chest/lymph nodes.
• The ipsilateral axillary lymph node dissection or other previous axillary surgery;
• Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, or psychiatric disease), inability to tolerate radiotherapy or systemic therapy if indicated;
• Current pregnancy and/or lactation;
• Inability or unwillingness to comply with protocol requirements.

Where it is running

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• Department of Radiation and Medical Oncology，Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China
• Changde Hospital, Xiangya school of Medicine, Central South University (The first people's hospital of Changde city) — Changde, Hunan, China
• Hunan cancer hospital/The affiliated cancer hospital of xiangya school of medicine,Central South university — Changsha, Hunan, China
• Department of Radiation and Medical Oncology, Affiliated Zhongshan Hospital of Dalian University — Dalian, Liaoning, China
• Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital) — Jinan, Shandong, China
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China
• The Second Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China
• Oncology Department, Guizhou Provincial People's Hospital — Guiyang, Guizhou, China
• Department of Chemoradiation Oncology, The Affiliated Lihuili Hospital of Ningbo University — Ningbo, Zhejiang, China

Full record on ClinicalTrials.gov

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