Breast CancerRELAXNCT07469267
Level I-II Axillary Irradiation in Breast Cancer With Sentinel-Node Macro-metastases
A study testing Entire regional nodal irradiation and Level I-II axillary irradiation in people with Breast Cancer and Radiotherapy, run by Fudan University at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Radiotherapy
- What is being tested?
- Entire regional nodal irradiation and Level I-II axillary irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,608 participants
- Where
- 15 sitesChina
- Study dates
- 24 Oct 2025to 31 Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Not yet recruiting
Changde Hospital, Xiangya school of Medicine, Central South University (The first people's hospital of Changde city)
Changde, Hunan
Tao Wu, +86-15873644000, radiotherapy_wutao@qq.com
Tao Wu
- Not yet recruiting
Hunan cancer hospital/The affiliated cancer hospital of xiangya school of medicine,Central South university
Changsha, Hunan
Hui Wang, +86-13973135460, wanghui@hnca.org.cn
Hui Wang
- Not yet recruiting
Department of Radiation and Medical Oncology, Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning
Zhe Wang, +86-13889445515, wangzhe@dlu.edu.cn
Zhe Wang
- Not yet recruiting
Oncology Department, Guizhou Provincial People's Hospital
Guiyang, Guizhou
Yong Li, +86-13628566285, liyong7229771@163.com
Yong Li
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
Ting Zhang, +86-15157125533, zezht@zju.edu.cn
Ting Zhang
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Xia Zhou, +86-13858065520, 1154389861@qq.com
Xia Zhou
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Qingyong Xu, +86-13664601878, xuqingyong1976@163.com
Qingyong Xu
- Not yet recruiting
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
Jinan, Shandong
Wei Huang, +86-13181713436, alvinbird@126.com
Wei Huang
- Not yet recruiting
Department of Chemoradiation Oncology, The Affiliated Lihuili Hospital of Ningbo University
Ningbo, Zhejiang
Kaitai Liu, +86-13732112205, lkt1982@126.com
Kaitai Liu
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Xiaoli Yu, MD, PhD, +86-13817893133, xiaoliyu@fudan.edu.cn
Li Zhang, M.D., +86-18121299516, lizhang_@fudan.edu.cn
- Not yet recruiting
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Chunling Jiang, +86-13979109200, jclil2002@163.com
Chunling Jiang
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Zhikun Liu, +86-13833185705, zhikunliu1978@163.com
Zhikun Liu
- Not yet recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Jing Wang, +86-13920762182, wj62182@126.com
Jing Wang
- Not yet recruiting
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Tengfei Chao, +86-17720503401, turnface@126.com
Tengfei Chao
- Not yet recruiting
Department of Radiation and Medical Oncology，Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Haijun Yu, +86-13971665181, haijunyu@whu.edu.cn
Haijun Yu
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJIECTIVE:
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.
SECONDARY OBJECTIVES:
- to estimate the difference of overall survival; II. to estimate the difference of ipsilateral regional recurrence; III. to estimate the difference of ipsilateral local regional recurrence; IV. to estimate the difference of distant recurrence; V. to estimate the difference of radiation related toxicities and quality of life.
Outline: Patients are randomized in a 1:1 ratio to two treatment arms.
Arm A (Level I-II axillary irradiation): Radiation is delivered to the breast after breast conserving surgery(BCS) or chest wall after mastectomy, level I-II axillary 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.
Arm B (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. IMN is optional and it is recommended to irradiate IMN when the tumor is located in the medial or central quadrant.
- Conditions
- Breast Cancer, Radiotherapy
- Being tested
- Entire regional nodal irradiation, Level I-II axillary irradiation
- Keywords
- Breast Cancer, Sentinel Node Macrometastases, Regional Nodal Irradiation, Level I-II Axillary Irradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entire regional nodal irradiationRadiation
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 irradiationRadiation
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 group | Role | What they receive |
|---|---|---|
| Entire regional nodal irradiation | Active comparator | 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. Receives: Radiation: Entire regional nodal irradiation |
| Level I-II axillary irradiation | Experimental | 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. Receives: Radiation: Level I-II axillary irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS)
Defined as time from randomization until to local, regional, or distant recurrence, or any death, or secondary primary cancer.
Measured: 5 years
Secondary outcomes (6)
Overall survival (OS)
Defined as the time from randomization to death from any cause.
Measured: 5 years
Regional Recurrence (RR)
Defined as the time from randomization to the date of the first ipsilateral axillary, supraclavicular, or internal mammary nodal recurrence.
Measured: 5 years
Local Regional Recurrence (LRR)
Defined as the time from randomization to the date of the first ipsilateral breast, chest wall, axillary, supraclavicular, or internal mammary nodal recurrence.
Measured: 5 years
Distance Recurrence (DR)
Defined as the time from randomization to the date of the first distant breast cancer recurrence.
Measured: 5 years
Safety outcomes
The frequency and severity of acute and late radiation-related adverse events are assessed and graded based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. For some events that CTCAE grading are not available, RTOG/the European Organization for Research and Treatment of Cancer (EORTC) late radiation morbidity scale and LENT-SOMA criteria are used.
Measured: 5 years
Patient-reported outcomes
Assessment of treatment-related symptoms, health-related quality of life via three questionnaires, including the EORTC Quality of Life Questionnaire (EORTC-QLQ-C30; version 3), breast cancer module (QLQ-BR23) and upper limb function via the Quick Disabilities of the Arm, Shoulder and Hand (q-DASH) questionnaire.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start24 Oct 2025
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,608 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoli Yu, Fudan University
- Investigators
- Xiaoli Yu, MD, PhD, Principal investigator, Fudan UniversityZhaozhi Yang, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469267
- Sponsor's protocol ID
- FDRT-BC026
- Acronym
- RELAX
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07469267
- Acronym / sponsor ID
- RELAX / FDRT-BC026
- Conditions
- Breast Cancer, Radiotherapy
- Keywords
- Breast Cancer, Sentinel Node Macrometastases, Regional Nodal Irradiation, Level I-II Axillary Irradiation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,608 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJIECTIVE:
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.
SECONDARY OBJECTIVES:
- to estimate the difference of overall survival; II. to estimate the difference of ipsilateral regional recurrence; III. to estimate the difference of ipsilateral local regional recurrence; IV. to estimate the difference of distant recurrence; V. to estimate the difference of radiation related toxicities and quality of life.
Outline: Patients are randomized in a 1:1 ratio to two treatment arms.
Arm A (Level I-II axillary irradiation): Radiation is delivered to the breast after breast conserving surgery(BCS) or chest wall after mastectomy, level I-II axillary 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.
Arm B (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. IMN is optional and it is recommended to irradiate IMN when the tumor is located in the medial or central quadrant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entire regional nodal irradiation | Active comparator | Radiation: Entire regional nodal irradiationRadiation 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. |
| Level I-II axillary irradiation | Experimental | Radiation: Level I-II axillary irradiationRadiation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entire regional nodal irradiationRadiation 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. | Radiation | Entire regional nodal irradiation |
| Level I-II axillary irradiationRadiation 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. | Radiation | Level I-II axillary irradiation |
Primary outcome
Disease Free Survival (DFS)
Time frame: 5 years
Defined as time from randomization until to local, regional, or distant recurrence, or any death, or secondary primary cancer.
6 secondary outcomes
Overall survival (OS)
Time frame: 5 years
Regional Recurrence (RR)
Time frame: 5 years
Local Regional Recurrence (LRR)
Time frame: 5 years
Distance Recurrence (DR)
Time frame: 5 years
Safety outcomes
Time frame: 5 years
Patient-reported outcomes
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoli Yu, MD, PhD principal investigator
Fudan University
Zhaozhi Yang, MD, PhD principal investigator
Fudan University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entire regional nodal irradiation and Level I-II axillary irradiation in people with Breast Cancer and Radiotherapy, run by Fudan University at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Yu, MD, PhD (+86-13817893133, xiaoliyu@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.