AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 18 Years - anyFemaleFudan University
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Female ≥ 18 years of age; 2. Newly diagnosed primary invasive breast cancer; 3. Clinically stage T1-3N0M0; 4. Patients received surgery as first treatment,and have undergone breast conserving-surgery or mastectomy (with or without breast reconstruction) with negative margins; 5. Have one or two macrometastases (\>2 mm) at sentinel lymph node biopsy,and without further axillary lymph node dissection; 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; 7. 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; 8. 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; 9. Patients have adequate organ function; 10. Acquirement of informed consent. Exclusion Criteria: 1. Patients have received neoadjuvant systemic therapy; 2. Clinical stage T4 or IV (metastatic) breast cancer, or presence of regional metastases before surgery; 3. 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; 4. History of previous radiotherapy towards the ipsilateral chest/lymph nodes. 5. The ipsilateral axillary lymph node dissection or other previous axillary surgery; 6. 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; 7. Current pregnancy and/or lactation; 8. Inability or unwillingness to comply with protocol requirements.
💊

What it tests

  • Entire regional nodal irradiation
  • Level I-II axillary irradiation
📍

Where

15 sites
Oncology Department, Guizhou Provincial People's Hospital
Guiyang, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Harbin Medical University Cancer Hospital
Harbin, China
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Department of Radiation and Medical Oncology,Zhongnan Hospital of Wuhan University
Wuhan, China
Changde Hospital, Xiangya school of Medicine, Central South University (The first people's hospital of Changde city)
Changde, China
Hunan cancer hospital/The affiliated cancer hospital of xiangya school of medicine,Central South university
Changsha, China
Department of Radiation and Medical Oncology, Affiliated Zhongshan Hospital of Dalian University
Dalian, China

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy