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

NCT07469267 · tracked via the Priya Life Science China tracker

Sponsor

Fudan University

Phase

Not applicable

Started

2025-10-24

Last updated

2026-03-13

Condition(s) studied

Breast CancerRadiotherapy

Investigational drug(s) / intervention(s)

Entire regional nodal irradiationLevel I-II axillary irradiation

Entire regional nodal irradiation: Radiation is delivered to the breast after BCS or chest wall after mastectomy, whole axillary lymph nodes (levels I-III) and supraclavicular lymph nodes. Internal mammary nodes(IMN) is optional and it is recommended to irradiate IMN when the tumor is located in the medial or central quadrant. Both hypofractionated and conventional fractionated radiation therapy are permitted: the conventional fractionated regimen is 50 Gy in 25 fractions of 2 Gy; the hypofractionated schedule is 42.56 Gy in 16 fractions of 2.66 Gy after mastectomy, or 40.05 Gy in 15 fractions of 2.67 Gy after breast-conserving surgery. Tumor bed after breast-conserving surgery is at the discretion of the treating physician, boost doses will be 10\~16 Gy in 5\~8 fractions of 2 Gy or 10.68\~16.2 Gy in 4\~6 fractions of 2.67 Gy.

Level I-II axillary irradiation: Radiation is delivered to the breast after BCS or chest wall after mastectomy and low axillary lymph nodes (levels I-II). Internal mammary nodes(IMN) is optional and it is recommended to irradiate IMN when the tumor is located in the medial or central quadrant. Both hypofractionated and conventional fractionated radiation therapy are permitted: the conventional fractionated regimen is 50 Gy in 25 fractions of 2 Gy; the hypofractionated schedule is 42.56 Gy in 16 fractions of 2.66 Gy after mastectomy, or 40.05 Gy in 15 fractions of 2.67 Gy after breast-conserving surgery. Tumor bed after breast-conserving surgery is at the discretion of the treating physician, boost doses will be 10\~16 Gy in 5\~8 fractions of 2 Gy or 10.68\~16.2 Gy in 4\~6 fractions of 2.67 Gy.

Study summary

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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Disease Free Survival (DFS) — 5 years
Defined as time from randomization until to local, regional, or distant recurrence, or any death, or secondary primary cancer.

Trial sites (15)

Facility	City	Region	Status
Oncology Department, Guizhou Provincial People's Hospital	Guiyang	Guizhou	Not Yet Recruiting
The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei	Not Yet Recruiting
Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	Not Yet Recruiting
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	Not Yet Recruiting
Department of Radiation and Medical Oncology，Zhongnan Hospital of Wuhan University	Wuhan	Hubei	Not Yet Recruiting
Changde Hospital, Xiangya school of Medicine, Central South University (The first people's hospital of Changde city)	Changde	Hunan	Not Yet Recruiting
Hunan cancer hospital/The affiliated cancer hospital of xiangya school of medicine,Central South university	Changsha	Hunan	Not Yet Recruiting
Department of Radiation and Medical Oncology, Affiliated Zhongshan Hospital of Dalian University	Dalian	Liaoning	Not Yet Recruiting
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)	Jinan	Shandong	Not Yet Recruiting
Fudan University Shanghai Cancer Center	Shanghai	Shanghai Municipality	Recruiting
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality	Not Yet Recruiting
Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin Municipality	Not Yet Recruiting
The Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang	Not Yet Recruiting
Zhejiang Cancer Hospital	Hangzhou	Zhejiang	Not Yet Recruiting
Department of Chemoradiation Oncology, The Affiliated Lihuili Hospital of Ningbo University	Ningbo	Zhejiang	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07469267 on ClinicalTrials.gov ↗ ← All trials in China