Evidence map›Paper›PMID 40466065›Full record

Trial reportThe New England journal of medicine2025

Omitting Regional Nodal Irradiation after Response to Neoadjuvant Chemotherapy.

Eleftherios P Mamounas, Hanna Bandos, Julia R White, Thomas B Julian, Atif J Khan, Simona F Shaitelman, Mylin A Torres, Frank A Vicini, Patricia A Ganz, Susan A McCloskey and 18 more

2 registry-linked trialsAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in The New England journal of medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 69 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01872975 naactive not recruitingnot on this map

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

TypeinterventionalSponsorNSABP Foundation IncRan2013 to 2028Enrolled1,636ConditionsStage IB Breast Cancer, Stage II Breast CancerArmsregional nodal XRT, chestwall XRT, WBI
NCT07643584 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

DEMAND - A Phase II Trial of De-Escalation of Axillary Management in Advanced Nodal Disease

TypeinterventionalSponsorUniversity of Kansas Medical CenterRan2026 to 2031Enrolled120ConditionsBreast CancerArmsAxillary Surgery
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. DEGRO practical guidelines: radiotherapy of breast cancer-regional nodal irradiation.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026
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  9. Author's reply to Rao et al.-"DEGRO practical guidelines: radiotherapy of breast cancer-regional nodal irradiation".Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026
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9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors.

Eleftherios P MamounasAdventHealth Cancer Institute, Orlando, FL.
Hanna BandosNRG Oncology Statistical and Data Management Center, Pittsburgh.
Julia R WhiteUniversity of Kansas Medical Center Comprehensive Cancer Center, Kansas City.
Thomas B JulianAllegheny Health Network Cancer Institute, Pittsburgh.
Atif J KhanMemorial Sloan Kettering Cancer Center, New York.
Simona F ShaitelmanUniversity of Texas M.D. Anderson Cancer Center, Houston.
Mylin A TorresWinship Cancer Institute, Emory University School of Medicine, Atlanta.
Frank A ViciniMichigan Healthcare Professionals, Pontiac.
Patricia A GanzJonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles.
Susan A McCloskeyUniversity of California, Los Angeles, Los Angeles.
Peter C LucasNational Surgical Adjuvant Breast and Bowel Project Pathology Lab, Pittsburgh.
Nilendu GuptaOhio State University, James Cancer Hospital, Columbus.
X Allen LiMedical College of Wisconsin, Milwaukee.
Beryl McCormickMemorial Sloan Kettering Cancer Center, New York.
Benjamin SmithUniversity of Texas M.D. Anderson Cancer Center, Houston.
Rahul D TendulkarCase Western Reserve University Case Comprehensive Cancer Center, Cleveland.
Vivek S KavadiTexas Oncology, US Oncology Network, The Woodlands.
Koji MatsumotoHyogo Cancer Center, Akashi, Hyogo, Japan.
Samantha Andrews SeawardKaiser Permanente National Cancer Institute Community Oncology Research Program, Vallejo, CA.
William J IrvinBon Secours Cancer Institute, Southeast Clinical Oncology Research Consortium, National Cancer Institute Community Oncology Research Program, Midlothian, VA.
Jolinta Y LinWinship Cancer Institute, Emory University School of Medicine, Atlanta.
Robert W MutterMayo Clinic, Rochester, MN.ORCID 0000-0002-9430-7323
Thierry M MuanzaMcGill University, Lady Davis Institute for Medical Research, Sir Mortimer B. Davis Jewish General Hospital, Montreal.
Jannifer StrombergCorewell Health, Oakland University Beaumont School of Medicine, Sterling Heights, MI.
Reshma JagsiWinship Cancer Institute, Emory University School of Medicine, Atlanta.
Anna C WeissUniversity of Rochester School of Medicine and Dentistry, Rochester, NY.
Walter J CurranPiedmont Oncology Institute, Atlanta.
Norman WolmarkUniversity of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI AKHILESH PANDEY · 1985 to 2026
$151.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
NRG Oncology Biospecimen BankU24CA196067 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Tanner J. Freeman, Nilsa Del Carmen Ramirez Milan · 2015 to 2026
$42.6M
NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA196067NCI NIH HHS UG1 CA189867NIH HHS Cancer Center Support Grant P30 CA008748NIH HHS P30CA015083NIH HHS R01-CA261932NIH HHS R01-CA272602NIH HHS U10CA180822NIH HHS U10CA180868NIH HHS U24CA196067NIH HHS UG1CA189867
6 · The paper itself

Abstract

backgroundThe benefit of regional nodal irradiation in the treatment of breast cancer is well established for patients with pathologically positive axillary nodes, but whether it is also beneficial for patients whose nodes become pathologically tumor free (ypN0) after neoadjuvant chemotherapy remains unclear.

methodsWe evaluated whether regional nodal irradiation improves outcomes in patients with biopsy-proven, node-positive breast cancer who reach ypN0 status after neoadjuvant chemotherapy. Patients with breast cancer with a clinical stage of T1 to T3 (tumor size, ≤2 cm to >5 cm), N1, and M0 (indicating spread to one to three axillary lymph nodes but no distant metastasis) who had ypN0 status after neoadjuvant chemotherapy were randomly assigned to receive regional nodal irradiation or no regional nodal irradiation. The primary end point was the interval of freedom from invasive breast cancer recurrence or death from breast cancer (invasive breast cancer recurrence-free interval). Secondary end points included the locoregional recurrence-free interval, the distant recurrence-free interval, disease-free survival, and overall survival. Safety was also assessed.

resultsA total of 1641 patients were enrolled in the trial; 1556 were included in the primary-event analysis: 772 in the irradiation group and 784 in the no-irradiation group. After a median follow-up of 59.5 months, 109 primary end-point events (50 in the irradiation group and 59 in the no-irradiation group) had occurred. Regional nodal irradiation did not significantly increase the invasive breast cancer recurrence-free interval (hazard ratio, 0.88; 95% confidence interval, 0.60 to 1.28; P = 0.51). Point estimates of survival free from the primary end-point events were 92.7% in the irradiation group and 91.8% in the no-irradiation group. Regional nodal irradiation did not increase the locoregional recurrence-free interval, the distant recurrence-free interval, disease-free survival, or overall survival. No deaths related to the protocol-specified therapy were reported, and no unexpected adverse events were observed. Grade 4 adverse events occurred in 0.5% of patients in the irradiation group and 0.1% of those in the no-irradiation group.

conclusionsThe addition of adjuvant regional nodal irradiation did not decrease the risk of invasive breast cancer recurrence or death from breast cancer in patients who had negative axillary nodes after neoadjuvant chemotherapy. (Funded by the National Institutes of Health; NSABP B-51-Radiation Therapy Oncology Group 1304 ClinicalTrials.gov number, NCT01872975.).

Indexed as

Breast NeoplasmsChemotherapy, AdjuvantLymphatic IrradiationNeoadjuvant TherapyNeoplasm Recurrence, LocalAdultAntineoplastic Combined Chemotherapy ProtocolsAxillaBiopsyBreastDisease-Free SurvivalFemaleFollow-Up StudiesHumansIncidenceKaplan-Meier Estimate

Identifiers

PMID40466065
PMCPMC12269788

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.