Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:58 AM
Study NCT ID:
NCT07469267
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Level I-II Axillary Irradiation in Breast Cancer With Sentinel-Node Macro-metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1608}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2035-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-08', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Free Survival (DFS)', 'timeFrame': '5 years', 'description': 'Defined as time from randomization until to local, regional, or distant recurrence, or any death, or secondary primary cancer.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '5 years', 'description': 'Defined as the time from randomization to death from any cause.'}, {'measure': 'Regional Recurrence (RR)', 'timeFrame': '5 years', 'description': 'Defined as the time from randomization to the date of the first ipsilateral axillary, supraclavicular, or internal mammary nodal recurrence.'}, {'measure': 'Local Regional Recurrence (LRR)', 'timeFrame': '5 years', 'description': 'Defined as the time from randomization to the date of the first ipsilateral breast, chest wall, axillary, supraclavicular, or internal mammary nodal recurrence.'}, {'measure': 'Distance Recurrence (DR)', 'timeFrame': '5 years', 'description': 'Defined as the time from randomization to the date of the first distant breast cancer recurrence.'}, {'measure': 'Safety outcomes', 'timeFrame': '5 years', 'description': '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.'}, {'measure': 'Patient-reported outcomes', 'timeFrame': '5 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Sentinel Node Macrometastases', 'Regional Nodal Irradiation', 'Level I-II Axillary Irradiation'], 'conditions': ['Breast Cancer', 'Radiotherapy']}, 'descriptionModule': {'briefSummary': 'The RELAX trial is an open-label, multicenter, non-inferiority, randomized, phase 3 clinical trial.\n\nMultiple 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.', 'detailedDescription': 'PRIMARY OBJIECTIVE:\n\nTo 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.\n\nSECONDARY OBJECTIVES:\n\nI. 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.\n\nOutline: Patients are randomized in a 1:1 ratio to two treatment arms.\n\nArm 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.\n\nArm 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female ≥ 18 years of age;\n2. Newly diagnosed primary invasive breast cancer;\n3. Clinically stage T1-3N0M0;\n4. Patients received surgery as first treatment,and have undergone breast conserving-surgery or mastectomy (with or without breast reconstruction) with negative margins;\n5. Have one or two macrometastases (\\>2 mm) at sentinel lymph node biopsy,and without further axillary lymph node dissection;\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;\n7. 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;\n8. 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;\n9. Patients have adequate organ function;\n10. Acquirement of informed consent.\n\nExclusion Criteria:\n\n1. Patients have received neoadjuvant systemic therapy;\n2. Clinical stage T4 or IV (metastatic) breast cancer, or presence of regional metastases before surgery;\n3. 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;\n4. History of previous radiotherapy towards the ipsilateral chest/lymph nodes.\n5. The ipsilateral axillary lymph node dissection or other previous axillary surgery;\n6. 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;\n7. Current pregnancy and/or lactation;\n8. Inability or unwillingness to comply with protocol requirements.'}, 'identificationModule': {'nctId': 'NCT07469267', 'acronym': 'RELAX', 'briefTitle': 'Level I-II Axillary Irradiation in Breast Cancer With Sentinel-Node Macro-metastases', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'FDRT-BC026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Entire regional nodal irradiation', 'description': '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.', 'interventionNames': ['Radiation: Entire regional nodal irradiation']}, {'type': 'EXPERIMENTAL', 'label': 'Level I-II axillary irradiation', 'description': '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.', 'interventionNames': ['Radiation: Level I-II axillary irradiation']}], 'interventions': [{'name': 'Entire regional nodal irradiation', 'type': 'RADIATION', 'description': '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.\n\nBoth 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.', 'armGroupLabels': ['Entire regional nodal irradiation']}, {'name': 'Level I-II axillary irradiation', 'type': 'RADIATION', 'description': '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.\n\nBoth 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.', 'armGroupLabels': ['Level I-II axillary irradiation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guiyang', 'state': 'Guizhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Li', 'role': 'CONTACT', 'email': 'liyong7229771@163.com', 'phone': '+86-13628566285'}, {'name': 'Yong Li', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Oncology Department, Guizhou Provincial People's Hospital", 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhikun Liu', 'role': 'CONTACT', 'email': 'zhikunliu1978@163.com', 'phone': '+86-13833185705'}, {'name': 'Zhikun Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Fourth Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingyong Xu', 'role': 'CONTACT', 'email': 'xuqingyong1976@163.com', 'phone': '+86-13664601878'}, {'name': 'Qingyong Xu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tengfei Chao', 'role': 'CONTACT', 'email': 'turnface@126.com', 'phone': '+86-17720503401'}, {'name': 'Tengfei Chao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haijun Yu', 'role': 'CONTACT', 'email': 'haijunyu@whu.edu.cn', 'phone': '+86-13971665181'}, {'name': 'Haijun Yu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Radiation and Medical Oncology，Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changde', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Wu', 'role': 'CONTACT', 'email': 'radiotherapy_wutao@qq.com', 'phone': '+86-15873644000'}, {'name': 'Tao Wu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Changde Hospital, Xiangya school of Medicine, Central South University (The first people's hospital of Changde city)", 'geoPoint': {'lat': 29.03205, 'lon': 111.69844}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Wang', 'role': 'CONTACT', 'email': 'wanghui@hnca.org.cn', 'phone': '+86-13973135460'}, {'name': 'Hui Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hunan cancer hospital/The affiliated cancer hospital of xiangya school of medicine,Central South university', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Dalian', 'state': 'Liaoning', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhe Wang', 'role': 'CONTACT', 'email': 'wangzhe@dlu.edu.cn', 'phone': '+86-13889445515'}, {'name': 'Zhe Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Radiation and Medical Oncology, Affiliated Zhongshan Hospital of Dalian University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Huang', 'role': 'CONTACT', 'email': 'alvinbird@126.com', 'phone': '+86-13181713436'}, {'name': 'Wei Huang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoli Yu, MD, PhD', 'role': 'CONTACT', 'email': 'xiaoliyu@fudan.edu.cn', 'phone': '+86-13817893133'}, {'name': 'Li Zhang, M.D.', 'role': 'CONTACT', 'email': 'lizhang_@fudan.edu.cn', 'phone': '+86-18121299516'}, {'name': 'Xiaoli Yu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunling Jiang', 'role': 'CONTACT', 'email': 'jclil2002@163.com', 'phone': '+86-13979109200'}, {'name': 'Chunling Jiang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Wang', 'role': 'CONTACT', 'email': 'wj62182@126.com', 'phone': '+86-13920762182'}, {'name': 'Jing Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ting Zhang', 'role': 'CONTACT', 'email': 'zezht@zju.edu.cn', 'phone': '+86-15157125533'}, {'name': 'Ting Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xia Zhou', 'role': 'CONTACT', 'email': '1154389861@qq.com', 'phone': '+86-13858065520'}, {'name': 'Xia Zhou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kaitai Liu', 'role': 'CONTACT', 'email': 'lkt1982@126.com', 'phone': '+86-13732112205'}, {'name': 'Kaitai Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Chemoradiation Oncology, The Affiliated Lihuili Hospital of Ningbo University', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}], 'centralContacts': [{'name': 'Xiaoli Yu, MD, PhD', 'role': 'CONTACT', 'email': 'xiaoliyu@fudan.edu.cn', 'phone': '+86-13817893133'}, {'name': 'Li Zhang, M.D.', 'role': 'CONTACT', 'email': 'lizhang_@fudan.edu.cn', 'phone': '+86-18121299516'}], 'overallOfficials': [{'name': 'Xiaoli Yu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}, {'name': 'Zhaozhi Yang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Department of Radiation Oncology, Fudan University Shanghai Cancer Center', 'investigatorFullName': 'Xiaoli Yu', 'investigatorAffiliation': 'Fudan University'}}}}