RecruitingNot ApplicableNCT07469267

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

Entire Regional Nodal Irradiation vs. Level I-II Axillary Irradiation in Clinically Node-negative Breast Cancer Patients With 1-2 Sentinel Node Macro-metastases (RELAX)：A Prospective, Multicenter, Randomized, Phase 3 Clinical Trial

Sponsor

Fudan University

Enrollment

1,608 participants

Start Date

Oct 24, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Radiotherapy

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: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether targeted radiation to the armpit (axillary) lymph node area can replace full lymph node removal surgery in breast cancer patients who have limited cancer spread to sentinel lymph nodes. **You may be eligible if...** - You are female, age 18 or older - You have newly diagnosed invasive breast cancer, stage T1–T3 with no distant spread - You had breast-conserving surgery or mastectomy with clear margins - You have one or two macrometastases (cancer deposits over 2 mm) in sentinel lymph nodes, with no further lymph node removal done - You have good overall health (ECOG 0 or 1) - You plan to receive appropriate hormone or anti-HER2 therapy if indicated - Radiation can begin within 12 weeks of your last surgery or chemotherapy **You may NOT be eligible if...** - You received chemotherapy or other systemic treatment before surgery - You have stage T4 or metastatic breast cancer - You have had prior breast cancer on the same side, or other cancers (with minor exceptions) - You previously had radiation to the same chest or lymph node area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONEntire 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.

RADIATIONLevel 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.

Locations(15)

Oncology Department, Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

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

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 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

Department of Chemoradiation Oncology, The Affiliated Lihuili Hospital of Ningbo University

Ningbo, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07469267

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