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Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy

StatusActive, Not Recruiting
PhasePhase 3
Started2014-02-24
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 60 months later Jan 1, 2026 → Jan 31, 2031
See other at-risk trials from Alliance for Clinical Trials in Oncology

Amendment history

The 50 most recent of 71 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-08-27
Study Status, Study Description, Eligibility, Contacts/Locations v70
Eligibility criteria+28 characters
[...] erican Joint Committee on Cancer (AJCC) staging 7th edition Patients >= 18 years of age No inflammatory breast cancer No other malignancy within 5 y [...]
Study description+116 characters
[...] proton radiation therapy (PRT) 5 days a week for 5-6 weeks. Patients will also undergo collection of blood on study. ARM II: Patients undergo axillary and nodal radiation therap [...] omprising 3D-CRT, IMRT, or PRT 5 days a week for 5-6 weeks. Patients will also undergo collection of blood on study. After completion of study treatment, patients are followed up at least every 6 months for 2 years and then annually for years 3 years-8.
Study sitesdetails revised at 5 of 1246 sites
2026-07-22
Study Identification, Study Status, Contacts/Locations v69
Primary completion pushed: 2026-01-01 → 2031-01-31
Completion pushed: 2026-01-01 → 2031-01-31
Study sitesdetails revised at 5 of 1246 sites
Study titlerevised
Comparison of Axillary Lymph Node Dissection withWith Axillary Radiation for Patients withWith Node-Positive Breast Cancer Treated withWith Chemotherapy
2025-01-09
Study Identification, Study Status, Contacts/Locations v68
Primary completion date2025-01-01→2026-01-01
Completion date2025-01-01→2026-01-01
Start date2014-02-07→2014-02-24
Study sitesdetails revised at 5 of 1246 sites
Study titlerevised
Comparison of Axillary Lymph Node Dissection Withwith Axillary Radiation for Patients Withwith Node-Positive Breast Cancer Treated Withwith Chemotherapy
2024-02-23
Study Status v67
Primary completion date2024-01-01→2025-01-01
Completion date2024-01-01→2025-01-01
2023-05-02
Study Status, Outcome Measures v66
Completion datenot stated→2024-01-01
Secondary endpointsdetails revised at 2 of 2 entries
Show 45 earlier versions
2022-08-02
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v65
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-01→2024-01-01
Start date2014-02→2014-02-07
Enrollment targetestimated 1660→confirmed 2012
Study sitesdetails revised at 1246 of 1246 sites
2022-06-03
Study Status, Contacts/Locations v64
Study sites1246 entries, revised
Novant Health Cancer SpecialistsInstitute - Matthews NHRMCNovant Health Cancer Institute Radiation Oncology - 16th StreetWilmington University of Wisconsin HospitalCarbone andCancer ClinicsCenter
2022-04-18
Study Status, Contacts/Locations v63
Study sitesdetails revised at 2 of 1246 sites
2022-03-22
Study Status, Contacts/Locations v62
Study sites1246 entries, revised
21stGenesisCare CenturyUSA Oncology- Henderson 21stGenesisCare CenturyUSA Oncology- Las Vegas 21stGenesisCare CenturyUSA Oncology- Vegas Tenaya 21stGenesisCare CenturyUSA Oncology- Fort Apache
2022-02-16
Study Status, Contacts/Locations v61
Study sites1246 entries, revised
JewishUofL HospitalHealth Medical Center Northeast
2022-01-11
Study Status, Contacts/Locations v60
Study sites1245→1246
2021-12-13
Study Status, Contacts/Locations v59
Study sites1243→1245
2021-11-11
Study Status, Contacts/Locations v58
Study sites1239→1243
2021-10-11
Study Status, Contacts/Locations v57
Study sites1226→1239
2021-06-09
Study Status, Contacts/Locations v56
Study sites1217→1226
2021-04-16
Study Status, Eligibility, Contacts/Locations v55
Study sites1212→1217
Eligibility criteria+43 characters
[...] omization At least one lymph node (sentinel or non-sentinel) excised during sentinel lymph node surgery with a metastasis greater than 0.2 mm in greatest dimension [...]
2021-03-05
Study Status, Contacts/Locations v54
Study sites1210→1212
2021-02-05
Study Status, Contacts/Locations v53
Study sites1198→1210
2021-01-08
Study Status, Contacts/Locations v52
Study sites1192→1198
2020-12-08
Study Status, Contacts/Locations v51
Study sites1189→1192
2020-11-10
Study Status, Contacts/Locations v50
Study sites1187→1189
2020-10-08
Study Status, Contacts/Locations v49
Study sites1186→1187
2020-09-03
Study Status, Contacts/Locations v48
Study sites1181→1186
2020-07-22
Study Status, Contacts/Locations v47
Study sites1173→1181
2020-06-03
Study Status, Contacts/Locations v46
Study sites1158→1173
2020-05-15
Suspended→Recruiting Study Status, Study Description, Study Design, Eligibility, Contacts/Locations v45
Trial statusSuspended→Recruiting
Reason stoppedStudy met its pre-registration patient goal, may reopen for additional patients.→not stated
Enrollment target2918→1660
Eligibility criteria+553 characters
Pre-Registration Eligibility Criteria: Patients ≥ 18 years of age Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior [...] o or at most 14 days after starting neoadjuvant chemotherapy. * Note: Biopsy of intramammary nodes does not fulfill eligibility criteria. Patients must have had estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2 (HER2) status (by immunohistochemistry [IHC] and/or fluorescence in situ hybridization [FISHISH]) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy. * Note: If HER2 status has not been clearly deter [...] [...]
Study description-1,878 characters
StudyPRIMARY OutlineOBJECTIVE: AllI. patients will undergo surgery to identify sentinel lymph node(s). If a lymph node (sentinel or non-sentinel) is determined to be positive on intra-operative pathology the patient will be registered/randomized intra-operatively. Patients who do not have a sentinel lymph node identified will not be re [...] To evaluate whether radiation to the undissected axilla and [...] t cancer recurrence-free interval in patients with positive SLNsentinel lymph node(s) (SLN[s]) after completion of neoadjuvant chemotherapy. SecondarySECONDARY ObjectivesOBJECTIVES: I. To evaluate whethe [...] [...]
Study sitesdetails revised at 1158 of 1158 sites
2020-05-06
Study Status, Contacts/Locations v44
Study sites1158 entries, revised
University of Arizona Cancer Center at Saint Joseph's Cancer Care SpecialistsCenter of Illinois-SwanseaO'Fallon HaysHaysMed MedicalUniversity of Kansas Health System Olathe Health Cancer Center OlatheAscension Medical Center Via Christi Hospital- Pittsburg University of Kansas Health System Saint Francis Hospital and Medical Center - TopekaCampus The University of Kansas Cancer Center - North The University of Kansas Cancer Center - Lee's Summit Ascension Saint Michael's Hospital
2020-04-09
Study Status, Contacts/Locations v43
Study sites1158 entries, revised
HawaiiQueen's OncologyCancer IncCenrer - POB I HawaiiQueen's OncologyCancer IncCenter - Kuakini HawaiiQueen's OncologyCancer IncCenter -Pali MomiPearlridge
2020-03-04
Study Status, Contacts/Locations v42
Study sites1158 entries, revised
Hematology/Oncology Clinic LLPPLLC Messino Cancer Care of Western North CarolinaCenters Radiology Associates of Appleton/ThedaCare Regional Medical Center - Appleton
2020-02-04
Study Status, Contacts/Locations v41
Study sites1158 entries, revised
Yale-NewSmilow HavenCancer ShorelineHospital MedicalCare Center - Guiford LawrenceSmilow Cancer Hospital Care Center - Waterford MultiCare Deaconess Cancer and MemorialBlood CancerSpecialty Center Rockwood Cancer- Treatment Center-DHEC-Downtown
2020-01-07
Study Status, Contacts/Locations v40
Study sites1158 entries, revised
Oncology Hematology Care Inc-Anderson Providence OncologyCancer Institute Clackamas Clinic MultiCare Deaconess Cancer and HematologyBlood CareSpecialty Southeast RockwoodCenter - North MultiCare Deaconess Cancer Treatmentand Blood Specialty Center Rockwood Clinic- Cancer Treatment Center-Valley
2019-11-19
Study Status, Contacts/Locations v39
Study sites1158 entries, revised
Beaumont Hospital ?- Dearborn Mission Hospital Inc-Memorial Campus MD Anderson inWest KatyHouston
2019-10-22
Recruiting→Suspended Study Status, Contacts/Locations v38
Trial statusRecruiting→Suspended
Reason stoppednot stated→Study met its pre-registration patient goal, may reopen for additional patients.
Study sitesdetails revised at 1158 of 1158 sites
2019-10-21
Study Status, Contacts/Locations v37
Study sites1158 entries, revised
City of Hope RanchoUpland UMass Cucamonga University of MassachusettsMemorial Medical SchoolCenter - University Campus Charleston Hematology Oncology Associates- Roper Charleston Hematology Oncology Associates- PA-Saint Francis GreenvillePrisma Health System Cancer Institute - Easley GreenvillePrisma Health System Cancer Institute - Butternut GreenvillePrisma Health System Cancer Institute - Faris Prisma Health Greenville Memorial Hospital GreenvillePrisma Health System Cancer Institute - Eastside GreenvillePrisma Health System Cancer Institute - Greer GreenvillePrisma Health System Cancer Ins [...] [...]
2019-09-18
Study Status, Contacts/Locations v36
Study sites1160→1158
2019-08-02
Study Status, Contacts/Locations v35
Study sites1161→1160
2019-06-18
Study Status, Contacts/Locations v34
Study sites1161 entries, revised
Florida Hospital Cancer InstituteAdventHealth Altamonte Florida HospitalAdventHealth Kissimmee FloridaAdventHealth HospitalMedical Group Urology at Orlando FloridaAdventHealth Urology Associates-Orlando Florida HospitalAdventHealth East Orlando Florida Hospital Cancer InstituteAdventHealth Winter Park Atrium Health LincolnPineville/LCI-LincolnPineville
2019-05-14
Study Status, Contacts/Locations v33
Study sites1155→1161
2019-02-19
Study Status, Contacts/Locations v32
Study sites1146→1155
2019-01-22
Study Status, Contacts/Locations v31
Study sites1132→1146
2018-12-04
Study Status, Sponsor/Collaborators v30
Collaborators1 to 2 entries
Canadian Cancer Trials Group
2018-11-19
Study Status, Contacts/Locations v29
Study sitesdetails revised at 3 of 1132 sites
2018-09-05
Study Status, Contacts/Locations v28
Study sites1129→1132
2018-08-06
Study Status, Contacts/Locations v27
Study sites1124→1129
2018-07-16
Study Status, Contacts/Locations v26
Study sites1112→1124
2018-06-08
Study Status, Contacts/Locations v25
Study sites1101→1112
2018-05-04
Study Status, Contacts/Locations v24
Study sites1094→1101
2018-04-06
Study Status, Contacts/Locations v23
Study sites1080→1094
2018-03-06
Study Status, Contacts/Locations v22
Study sites1074→1080
2018-02-05
Study Status, Contacts/Locations v21
Study sites1071→1074
This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.
Trial Details
NCT Number NCT01901094
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI), Canadian Cancer Trials Group
Conditions Stage II Breast Cancer, Stage IIIA Breast Cancer
Enrollment 2,012 participants
Start Date 2014-02-24
Primary Completion 2031-01-31 (estimated)
Study Completion 2031-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-31